Efficacy of radial shock wave therapy for ankle spasticity in patients with stroke within 3 months of onset: a prospective quasi-experimental study

So, still a failure; no cure for spasticity. The goal is to cure spasticity, not just reduce it.

When you are the 1 in 4 per WHO that has a stroke with spasticity, you'll want your spasticity cured. You better start solving that now.

Since you are using a subjective measurement scale(Modified Ashworth Scale) nothing here inspires any sort of confidence. In fact I would assume that the participants are using the Hawthorne effect to please the researchers. 

Efficacy of radial shock wave therapy for ankle spasticity in patients with stroke within 3 months of onset: a prospective quasi-experimental study

• Yuichi Hiramatsu,
• Hajime Yagura,
• Hiroaki Fujimoto,
• Megumi Hatakenaka,
• Teiji Kawano,
• Shota Segawa,
• Makiko Rai,
• Ryutaro Hayashi,
• Akihiko Nakae,
• Haruka Asano,
• Takuya Ogawa &
• Ichiro Miyai 

We are providing an unedited version of this manuscript to give early access to its findings. Before final publication, the manuscript will undergo further editing. Please note there may be errors present which affect the content, and all legal disclaimers apply.

Abstract

Background

Extracorporeal shock wave therapy (ESWT) is widely used to reduce poststroke spasticity (PSS). However, limited evidence exists regarding its efficacy in patients with stroke within 3 months of onset. Therefore, this study aimed to investigate the association between ESWT administered 1 to 3 months after stroke and changes in spasticity and joint mobility in patients with PSS.

Methods

Prospective quasi-experimental study. Fifty-two patients with PSS affecting the ankle joint were enrolled from March 2023 to March 2025, and allocated into three groups based on the time elapsed from stroke onset: 1, 2, or 3 months. All patients underwent radial ESWT to the gastrocnemius and soleus muscles once weekly for 3 consecutive weeks. Spasticity and joint mobility were evaluated using the Modified Ashworth Scale (MAS) and passive range of motion (PROM) measurements before and after each session, and at 1 and 5 weeks post-treatment.

Results

Except for the MAS score obtained after the first session, significant immediate reductions in the MAS scores and PROM measurements were observed after all shock wave therapy sessions. Compared to baseline, cumulative changes were greatest after the third session, with a mean reduction of 0.6 points in the MAS score and a 6.4° increase in the PROM. These changes were maintained for 5 weeks. No serious adverse events related to shock wave therapy were reported.

Conclusions

ESWT during the early subacute stage was associated with improvements(NOT GOOD ENOUGH!) in spasticity and joint mobility in patients with PSS. Repeated sessions showed greater cumulative changes compared with a single session.

Trial registration UMIN-CTR000050477.

Using the Barthel Index and modified Rankin Scale as Outcome Measures for Stroke Rehabilitation Trials; A Comparison of Minimum Sample Size Requirements

The Rankin Scale and the Barthel Index are subjective, so should have no place in measuring recovery. 

I consider the Rankin scale useless, not objective except for #6, dead?

Rankin Scale and the Berthel Index ARE NOT DAMAGE DIAGNOSES, they do not give you the 3d location of your dead and damaged neurons. In my opinion, they are FUCKING WORTHLESS to getting you recovered! 

The latest here:

Using the Barthel Index and modified Rankin Scale as Outcome Measures for Stroke Rehabilitation Trials; A Comparison of Minimum Sample Size Requirements

Kris McGill, PhDa kris.mcgill.research@outlook.com ∙ Catherine Sackley, PhDb ∙ Jon Godwin, PhDc ∙ … ∙ Belen Rubio Ballester, PhDe ∙ Marian C Brady, PhDa On behalf of VISTA-Rehabilitation collaborators⁎ … Show more

Abstract

Underpowered trials risk inaccurate results. Recruitment to stroke rehabilitation randomised controlled trials (RCTs) is often a challenge. Statistical simulations offer an important opportunity to explore the adequacy of sample sizes in the context of specific outcome measures. We aimed to examine and compare the adequacy of stroke rehabilitation RCT sample sizes using the Barthel Index (BI) or modified Rankin Scale (mRS) as primary outcomes.

We conducted computer simulations using typical experimental event rates (EER) and control event rates (CER) based on individual participant data (IPD) from stroke rehabilitation RCTs. Event rates are the proportion of participants who experienced clinically relevant improvements in the RCT experimental and control groups. We examined minimum sample size requirements and estimated the number of participants required to achieve a number needed to treat within clinically acceptable boundaries for the BI and mRS.

Results 

We secured 2350 IPD (18 RCTs). For a 90% chance of statistical accuracy on the BI a rehabilitation RCT would require 273 participants per randomised group. Accurate interpretation of effect sizes would require 1000s of participants per group. Simulations for the mRS were not possible as a clinically relevant improvement was not detected when using this outcome measure. Stroke rehabilitation RCTs with large sample sizes are required for accurate interpretation of effect sizes based on the BI. The mRS lacked sensitivity to detect change and thus may be unsuitable as a primary outcome in stroke rehabilitation trials.

Measuring arm function early after stroke: is the DASH good enough?

 Nothing objective in this questionnaire so very little use in mapping this to the EXACT needed protocols! 'Measurements' do nothing towards recovery unless they point DIRECTLY TO EXACT RECOVERY PROTOCOLS!
DASH QUESTIONAIRE HERE:

Measuring arm function early after stroke: is the DASH good enough?

Karen Baker 1, Louise Barrett 2, E Diane Playford 1, Trefor Aspden 3, Afsane Riazi 3, Jeremy Hobart 2 Correspondence to> Professor Jeremy Hobart, Clinical Neurology Research Group, Plymouth University Peninsula Schools of Medicine and Dentistry, Room N13 ITTC Building, Plymouth Science Park, Derriford, Plymouth PL6 8BX, UK; jeremy.hobart@plymouth.ac.uk

Abstract

Objective 

Despite a growing call to use patient-reported outcomes in clinical research, few are available for measuring upper limb function post-stroke. We examined the Disabilities of the Arm, Shoulder and Hand (DASH) to evaluate its measurement performance in acute stroke. In doing so, we compared results from traditional and modern psychometric methods.

Methods 

172 people with acute stroke completed the DASH. Those with upper limb impairments completed the DASH again at 6 weeks (n=99). Data (n=271) were analysed using two psychometric paradigms: traditional psychometric (Classical Test Theory, CTT) analyses examined data completeness, scaling assumptions, targeting, reliability and responsiveness; Rasch Measurement Theory (RMT) analyses examined scale-to-sample targeting, scale performance and person measurement.

Results 

CTT analyses implied the DASH was psychometrically robust in this sample. Data completeness was high, criteria for scaling assumptions were satisfied (item-total correlations 0.55–0.95), targeting was good, internal consistency reliability was high (Cronbach's α=0.99) and responsiveness was clinically moderate (effect size=0.51). However, RMT analyses identified important limitations: scale-to-sample targeting was suboptimal, 4 items had disordered response category thresholds, 16 items exhibited misfit, 3 pairs of items had high residual correlations (>0.60) and 84 person fit residuals exceeded the recommended range.

Conclusions 

RMT methods identified limitations missed by CTT and indicate areas for improvement of the DASH as an upper limb measure for acute stroke. Findings, similar to those identified in multiple sclerosis, highlight the need for scales to have strong conceptual underpinnings, with their development and modification guided by sophisticated psychometric methods.

https://doi.org/10.1136/jnnp-2015-310557

EXPRESS: Methodology of the Fatigue After STroke Educational Recovery (FASTER) group randomised controlled trial

My jaw dropped to the floor on this one. SUBJECTIVE FATIGUE? You're just trying to make patients 'think' they are better by doing nothing concrete. What fucking objective bullshit.

EXPRESS: Methodology of the Fatigue After STroke Educational Recovery (FASTER) group randomised controlled trial

 

 

Show all authors

Suzanne Lyn Barker-Collo, Rita Krishnamurthi, Takayoshi Ikeda, ...

First Published March 16, 2021 Research Article 

https://doi.org/10.1177/17474930211006295

Article information

Abstract

Rationale: 

Post-stroke fatigue (PSF) affects up to 92% of stroke survivors, causing significant burden. Educational Cognitive Behavioural Therapy (CBT) fatigue groups show positive results in other health conditions.

Aims: 

FASTER will determine if educational CBT Fatigue Management Group (FMG) reduces subjective fatigue in adults post-stroke.

Design: 

Prospective, multi-centre, two-arm, single-blind, phase III RCT (parallel, superiority design), with blinded assessments at baseline, 6-weeks, and 3-months post-programme commencement. With n=200 (100 per group, 20% drop-out) the trial will have 85% power (2-sided, p= 0.05) to detect minimally clinically important differences of 0.60 (SD=1.27) in Fatigue severity scale and 1.70 points (SD=3.6) in Multidimensional Fatigue Inventory-20 at 3-months.

Outcomes: 

Primary outcomes are self-reported fatigue severity and dimensionality (i.e., types of fatigue experienced - physical, psychological and/or cognitive) post-intervention (6-weeks). Secondary outcomes include subjective fatigue at 3-months, and health-related quality of life, disability, sleep, pain, mood, service use/costs, and caregiver burden at each follow-up.

Discussion: 

FASTER will determine whether FMG reduces fatigue post-stroke.(It does nothing of the sort.)

Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000626167).

Keywords Cognitive Behavioural, Group, Intervention, Protocol, Stroke, fatigue

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EXPRESS: Methodology of the Fatigue After STroke Educational Recovery (FASTER) group randomised controlled trial

 Wrong, wrong, wrong aim. Survivors want reductions in objective fatigue, NOT YOUR LAZY IDEA of subjective fatigue. My God, your mentors and senior researchers allowed that crapola aim? Subjective is way too easily swayed by researcher bias and leading questions.

EXPRESS: Methodology of the Fatigue After STroke Educational Recovery (FASTER) group randomised controlled trial

Show all authors

Suzanne Lyn Barker-Collo, Rita Krishnamurthi, Takayoshi Ikeda, ...

First Published March 16, 2021 Research Article 

https://doi.org/10.1177/17474930211006295

Article information

 

Abstract

Rationale: Post-stroke fatigue (PSF) affects up to 92% of stroke survivors, causing significant burden. Educational Cognitive Behavioural Therapy (CBT) fatigue groups show positive results in other health conditions.

Aims: FASTER will determine if educational CBT Fatigue Management Group (FMG) reduces subjective fatigue in adults post-stroke.

Design: Prospective, multi-centre, two-arm, single-blind, phase III RCT (parallel, superiority design), with blinded assessments at baseline, 6-weeks, and 3-months post-programme commencement. With n=200 (100 per group, 20% drop-out) the trial will have 85% power (2-sided, p= 0.05) to detect minimally clinically important differences of 0.60 (SD=1.27) in Fatigue severity scale and 1.70 points (SD=3.6) in Multidimensional Fatigue Inventory-20 at 3-months.

Outcomes: Primary outcomes are self-reported fatigue severity and dimensionality (i.e., types of fatigue experienced - physical, psychological and/or cognitive) post-intervention (6-weeks). Secondary outcomes include subjective fatigue at 3-months, and health-related quality of life, disability, sleep, pain, mood, service use/costs, and caregiver burden at each follow-up.

Discussion: FASTER will determine whether FMG reduces fatigue post-stroke.

Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000626167).

Keywords Cognitive Behavioural, Group, Intervention, Protocol, Stroke, fatigue

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Pants dressing failure

 I can't successfully get my pants, shorts or underwear on without sitting down. I failed at the portion of the Berg Balance scale where you are supposed to stand on one leg for 5 seconds. I failed at this in therapy all the time, still fail at it now(maybe 2 seconds now). NEVER RECEIVED ANY  therapy protocols to address that failure. It seems most of the point of my physical therapy was testing so the PTs could successfully bill the insurance companies.  There was absolutely no pay for performance in any of my therapy. It there was, nobody would have gotten paid. THAT would concentrate your hospital's attention. I would have to say nothing in the Berg Balance scale is objective, 0-4 scale means subjective.

Berg Balance Scale

Objective

The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.

Intended Population

Elderly population with impairment of balance, patients with acute stroke (Berg et al 1995, Usuda et al 1998).

Method of Use

Equipment required

[1]

• A ruler
• 2 standard chairs (one with arm rests, one without)
• A footstool or step
• 15 ft walkway
• Stopwatch or wristwatch

The scale

Name: __________________________________ Date: ___________________

Location: ________________________________ Rater: ___________________

ITEM DESCRIPTION SCORE (0-4)

Sitting to standing ________
Standing unsupported ________
Sitting unsupported ________
Standing to sitting ________
Transfers ________
Standing with eyes closed ________
Standing with feet together ________
Reaching forward with outstretched arm ________
Retrieving object from floor ________
Turning to look behind ________
Turning 360 degrees ________
Placing alternate foot on stool ________
Standing with one foot in front ________
Standing on one foot ________

Total ________

 

A Case Series Clinical Trial of a Novel Approach Using Augmented Reality That Inspires Self-body Cognition in Patients With Stroke: Effects on Motor Function and Resting-State Brain Functional Connectivity

Since you are using subjective measurement scales(Fugl-Meter and Modified Ashworth Scale) nothing here inspires any sort of confidence. In fact I would assume that the participants are using the Hawthorne effect to please the researchers.

A Case Series Clinical Trial of a Novel Approach Using Augmented Reality That Inspires Self-body Cognition in Patients With Stroke: Effects on Motor Function and Resting-State Brain Functional Connectivity

Fuminari Kaneko^1,2*, Keiichiro Shindo^1,2, Masaki Yoneta^1,2,3, Megumi Okawada^1,2,3, Kazuto Akaboshi^1,2,3 and Meigen Liu¹

• ¹Department of Rehabilitation Medicine, Keio University School of Medicine, Tokyo, Japan
• ²Department of Rehabilitation, Shonan Keiiku Hospital, Fujisawa, Japan
• ³Hokuto Social Medical Corporation, Obihiro, Japan

Barring a few studies, there are not enough established treatments to improve upper limb motor function in patients with severe impairments due to chronic stroke. This study aimed to clarify the effect of the kinesthetic perceptional illusion induced by visual stimulation (KINVIS) on upper limb motor function and the relationship between motor function and resting-state brain networks. Eleven patients with severe paralysis of upper limb motor function in the chronic phase (seven men and four women; age: 54.7 ± 10.8 years; 44.0 ± 29.0 months post-stroke) participated in the study. Patients underwent an intervention consisting of therapy using KINVIS and conventional therapeutic exercise (TherEX) for 10 days. Our originally developed KiNvis™ system was applied to induce KINVIS while watching the movement of the artificial hand. Clinical outcomes were examined to evaluate motor functions and resting-state brain functional connectivity (rsFC) by analyzing blood-oxygen-level-dependent (BOLD) signals measured using functional magnetic resonance imaging (fMRI). The outcomes of motor function (Fugle-Meyer Assessment, FMA) and spasticity (Modified Ashworth Scale, MAS) significantly improved after the intervention. The improvement in MAS scores for the fingers and the wrist flexors reached a minimum of clinically important differences. Before the intervention, strong and significant negative correlations between the motor functions and rsFC of the inferior parietal lobule (IPL) and premotor cortex (PMd) in the unaffected hemisphere was demonstrated. These strong correlations were disappeared after the intervention. A negative and strong correlation between the motor function and rsFC of the bilateral inferior parietal sulcus (IPS) significantly changed to strong and positive correlation after the intervention. These results may suggest that the combination approach of KINVIS therapy and TherEX improved motor functions and decreased spasticity in the paralyzed upper extremity after stroke in the chronic phase, possibly indicating the contribution of embodied-visual stimulation. The rsFC for the interhemispheric IPS and intrahemispheric IPL and PMd may be a possible regulatory factor for improving motor function and spasticity.
Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01274117.

A Revised Motor Activity Log Following Rasch Validation (Rasch-Based MAL-18) and Consensus Methods in Chronic Stroke and Multiple Sclerosis

I'd have to say this is useless for rehab.

Motor Activity Log (MAL)

Subjective so not useful for determining what rehab protocols should be used. Of course such protocols don't exist yet.

 

A Revised Motor Activity Log Following Rasch Validation (Rasch-Based MAL-18) and Consensus Methods in Chronic Stroke and Multiple Sclerosis 

Ann Van de Winckel PhD, MSPT, PT, Lynne Gauthier, PhD

First Published August 18, 2019 Brief Report

https://doi.org/10.1177/1545968319868717

Article information

Abstract

Objectives. To derive a shorter version of the Motor Activity Log Quality-of-Movement Scale (MAL-28) with enhanced content and construct validity.
Design. Validation cohort.
Setting. Outpatient rehabilitation within an academic laboratory.  
Participants. Retrospective consecutive sample of 149 community-dwelling adults with chronic mild/moderate upper-extremity hemiparesis caused by stroke or multiple sclerosis (MS). Intervention. Not applicable.  
Methods. Participants received the MAL-28 at baseline and following upper-extremity rehabilitation. Rasch Measurement Theory informed threshold ordering of scoring categories, tests of fit, differential item functioning, targeting, response dependency, local dependency, and reliability (person separation index [PSI]). Seasoned examiners rated the content validity of each item. Test-retest reliability of the revised scale was calculated.  
Results. We established content and construct validity for 18 items. The resultant 18-item MAL fit the model (χ² = 77.93; df = 72; P = .30) and targeted the population—that is, minimal floor (12.08%) or ceiling effects (0%), with acceptable reliability (PSI = 0.84) and good test-retest reliability [ICC(1, 1) = 0.86]. The hierarchy of item difficulty was independent of sex, age, affected side, diagnosis, or intervention type used, and there was local dependency in 3 pairs of items. Responses from a subsequent testing session were dependent on the responses from prior testing, indicating response dependency, for which a correction was proposed. Once response dependency was neutralized, there was a 15% greater treatment response.  
Conclusions. Content and construct validity are established for Rasch-based MAL-18 for chronic stages of stroke and MS. A Rasch-based conversion table enables clinical use of the MAL-18.

Keywords validity, Motor Activity Log, stroke, multiple sclerosis, Rasch, upper extremity

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Acute stroke rehabilitation for gait training with cyborg type robot Hybrid Assistive Limb: A pilot study

You mean these earlier two were not enough to determine efficacy?

FIM is pretty much useless since it is subjective.Cherry picking participants again because those who can walk at one week had much smaller strokes. 

 

A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton – The HALESTRO Study (HAL-Exoskeleton STROke Study)

April 2019 

Biofeedback effect of hybrid assistive limb in stroke rehabilitation: A proof of concept study using functional near infrared spectroscopy

January 2018

The latest here. 

 

Acute stroke rehabilitation for gait training with cyborg type robot Hybrid Assistive Limb: A pilot study

Author links open overlay panelChiakiYokota^ac

YukioYamamoto^aMasatoshiKamada^aMichikazuNakai^bKunihiroNishimura^bDaisukeAndo^cTakeoSato^cMasatoshiKoga^cMasafumiIhara^dKazunoriToyoda^cYasuyukiFujimoto^aHirotakaOdani^aKazuoMinematsu^cTakashiNakajima^e

https://doi.org/10.1016/j.jns.2019.07.012Get rights and content

Under a Creative Commons license

open access

Highlights

•

Hybrid Assistive Limb (HAL) promotes functional recovery post-stroke.

•

There is limited published data on the efficacy of HAL on gait training post-stroke.

•

The FIM scale is useful to gauge efficacy of HAL for acute stroke rehabilitation.

Abstract

Robot-assisted gait training following acute stroke could allow patients with severe disability to receive a high dosage and intensity of gait training compared with conventional physical therapy (CP). However, given the limited data on gauging the efficacy of Hybrid Assistive Limb (HAL) on gait training in patients with acute stroke, we aimed to evaluate several outcome measures following gait training with HAL. Patients with first-ever stroke, who required a walking aid and were able to start gait training within 1 week of stroke onset were included in the current study. Patients were assigned to either the CP or HAL group. Outcome measures were collected at baseline, and at the 2nd (at 2–6 weeks), and 3rd (at 3–5 months) assessments. All patients underwent physical therapy until the 3rd assessment; patients in the HAL group underwent gait training using HAL until the 2nd assessment. Thirty-seven patients (19 from CP and 18 from HAL, median age = 69 years) completed the study. At the 2nd assessment, the total Functional Independence Measure (FIM) score was higher in the HAL group than in the CP group (90.1 vs. 79.0, p = 0.042). In conclusion, the FIM scale could be used to identify responsiveness to acute stroke rehabilitation using HAL.

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Keywords

Robot-assisted rehabilitation

Acute stroke

Gait training

HAL

FIM

Measures

1. Introduction

Minimizing physical impairment and facilitating functional recovery following stroke is the most important target of managing patients with acute stroke. There is accumulating evidence of enhanced plasticity, such as alterations of gene expression, inhibitory/excitatory synaptic input balance, and structural changes including synaptogenesis, which occur immediately after stroke [[1], [2], [3], [4], [5]]. Task-specific motor training that is initiated soon after stroke facilitates the reorganization of connections in a sensitive manner, which reportedly induces dramatic recovery if residual motor cortical areas are spared [[6], [7], [8]]. Thus, motion-focused training during the early phase of post-stroke may prove to be a promising intervention to increase the resolution of impairment in a proportional manner in patients with stroke.

There are still several challenges associated with making an acute stroke rehabilitation protocol. A very early rehabilitation trial (AVERT) demonstrated that a higher dose and very early mobilization within 24 h of stroke onset in acute strokes did not improve functional outcome at 3 months in patients with very early mobilization, compared to those who received usual care [9]. According to a meta-analysis, newly developed electromechanical-assisted training using various devices for walking, in combination with physical therapy, within 3 months after stroke improved independent walking compared with gait training without a device [10]. However, a device selection and rehabilitation protocol to enhance recovery of function in patients with acute stroke has not yet been established.

A cyborg-type robot, Hybrid Assistive Limb (HAL), which is manufactured by Cyberdyne Inc., Tsukuba, Japan, is a promising robotic device using innovative technology cybernics, where man and machine are connected mechanically and electronically, is used in the system. A biped non-medical model of HAL, HAL-FL05, was chosen in the present clinical setting according to Japanese device regulation. Briefly, HAL can estimate and decode the wearer's motion intension of bilateral hips and knee joints in real time from bioelectrical signals, such as the wearer's motor unit potentials on the skin with joint angles and shoe force plate signals analyses. It can enhance the wearer's gait movement by means of appropriate actuator torque using four actuators on the bilateral hip and knee joints, as described in detail elsewhere [11]. In Japan, HAL was approved as a medical device for patients with eight rare neuromuscular diseases in 2015; however, it has not yet been approved for patients with acute stroke. Although there are reports on the safety or feasibility of the HAL system [12,13], and its beneficial effects on gait [14,15], its effectiveness on gait training following acute stroke has not yet been confirmed. Before a randomized controlled clinical trial to test the efficacy of HAL in patients with acute stroke can be conducted, appropriate outcome measures must first be established.

The aim of the present study was to evaluate several outcome measures following gait training, which was initiated within 1 week of acute stroke onset, to design a confirmatory clinical trial for gait training using HAL in the future.

More at link.

Individualised treatment the future for stroke patients

Too long, didn't listen.  This falls into the same trap as those stating, 'All strokes are different, all stroke recoveries are different'.  Anybody that says this hasn't understood stroke at all. There are 10 million stroke survivors a year, the basics of their damage will be quite similar so recovery can be similar.

First we need objective damage diagnosis. None of this subjective crapola of  these:

•     The Fugl-Meyer upper extremity scale has no objective distinction for changes in ability and thus would be useless as a measurement tool.

• The Modified Ashworth Scale is way too subjective to be of any use in knowing if improvements are occurring.   

• FIM is pretty much useless since it is subjective. 

• Rankin scale is worthless, not objective except for 6 - death.

• You still don't know that the NIHSS subjective stroke scale is worthless?

 

 

 

Second; Stroke rehab protocols with the highest efficacy are then mapped to the damage diagnosis and successfully implemented to recovery. 

 

Individualised treatment the future for stroke patients

When your family member has a stroke, you get thrown headfirst into a health system that can feel big, scary and confusing.
So how can we make stroke recovery more patient focused? How can we listen to the people living through this hard time to create a recovery program that works best for them?
Gillian Mason, clinical trials manager, physiotherapist and researcher with the Hunter Medical Research Institute, is asking this question in her work.

Duration: 12min 29sec

Broadcast: Tue 25 Jun 2019, 9:00am

Comparing the responsiveness of the Functional Autonomy Measurement System (SMAF) with that of the Functional Independence Measure (FIM) in post-stroke rehabilitation

Since neither of these is objective they are pretty much useless in deciding what rehab protocol is needed for specific recoveries. 

Functional Autonomy Measurement System

FIM is pretty much useless since it is subjective.

 

Comparing the responsiveness of the Functional Autonomy Measurement System (SMAF) with that of the Functional Independence Measure (FIM) in post-stroke rehabilitation

Impact of infarct location on functional outcome following endovascular therapy for stroke

You mean we might finally get infarct location mapped to functional disability? And that could mean objective damage diagnosis rather than the subjective crapola of the Rankin scale.  Progress might finally be made.  

Impact of infarct location on functional outcome following endovascular therapy for stroke

1. Charlotte Rosso1,2,
2. Raphael Blanc3,
3. Julien Ly1,2,
4. Yves Samson1,2,
5. Stéphane Lehéricy1,4,
6. Benjamin Gory5,
7. Gautier Marnat6,
8. Mikael Mazighi3,
9. Arturo Consoli7,
10. Julien Labreuche8,
11. Suzana Saleme9,
12. Vincent Costalat10,
13. Serge Bracard5,
14. Hubert Desal11,
15. Michel Piotin3,
16. Bertrand Lapergue7
17. on behalf of the ASTER Trial and Pitié-Salpêtrière Investigators

Author affiliations

Abstract

Objectives The relationship between stroke topography (ie, the regions damaged by the infarct) and functional outcome can aid clinicians in their decision-making at the acute and later stages. However, the side (left or right) of the stroke may also influence the identification of clinically relevant regions. We sought to determine which brain regions are associated with good functional outcome at 3 months in patients with left-sided and right-sided stroke treated by endovascular treatment using the diffusion-weighted imaging-Alberta Stroke Program Early CT Score (DWI-ASPECTS).

Methods Patients with ischaemic stroke (n = 405) were included from the ASTER trial and Pitié-Salpêtrière registry. Blinded readers rated ASPECTS on day 1 DWI. Stepwise logistic regression analyses were performed to identify the regions related to 3-month outcome in left (n = 190) and right (n = 215) sided strokes with the modified Rankin scale (0–2) as a binary independent variable and with the 10 regions-of-interest of the DWI-ASPECTS as independent variables.

Results Median National Institute of Health Stroke Scale (NIHSS) at baseline was 17 (IQR: 12–20), median age was 70 years (IQR: 58–80) and median day-one NIHSS 9 (IQR: 4–18). Not all brain regions have the same weight in predicting good outcome at 3 months; moreover, these regions depend on the affected hemisphere. In left-sided strokes, the multivariate analysis revealed that preservation of the caudate nucleus, the internal capsule and the cortical M5 region were independent predictors of good outcome. In right-sided strokes, the cortical M3 and M6 regions were found to be clinically relevant.

Conclusion Cortical non-motors areas related to outcome differed between left-sided and right-sided strokes. This difference might reflect the specialisation of the dominant and non-dominant hemispheres for language and attention, respectively. These results may influence decision-making at the acute and later stages.

Trial registration number NCT02523261.

http://dx.doi.org/10.1136/jnnp-2018-318869

Utility-weighted modified Rankin Scale: Still too crude to be a truly patient-centric primary outcome measure?

I can't tell what this actually is but it has been out for 5 years already. But since the original Rankin scale was totally subjective and pretty much useless I don't see how this improves things.  Until we get to an objective 3d damage diagnosis, location and size of dead and damaged neurons, we will never get to rehab protocols based on factual objective criteria. Until then your doctor and therapists are completely guessing what needs to be fixed. 

See this example of nine reasons for a movement disability:

You can't tell me these all have the same solution, I'm not that stupid.
1. Penumbra damage to the motor cortex.
2. Dead brain in the motor cortex.
3. Penumbra damage in the pre-motor cortex.
4. Dead brain in the pre-motor cortex.
5. Penumbra damage in the executive control area.
6. Dead brain in the executive control area.
7. Penumbra damage in the white matter underlying any of these three.
8. Dead brain in the white matter underlying any of these three.
9. Spasticity preventing movement from occurring.
First we need an objective 3d damage diagnosis, without that there is no point in going forward. Dr. Watson likely to the rescue. 

 

A Utility-Weighted Modified Rankin Scale: Derivation and Application to Completed Stroke Trials (P5.008)

April 2014

 

Utility-weighted modified Rankin Scale: Still too crude to be a truly patient-centric primary outcome measure?

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Venesha Rethnam, Julie Bernhardt, Helen Dewey, ...

First Published February 12, 2019 Research Article

https://doi.org/10.1177/1747493019830583

Article information

Abstract

Background

The utility-weighted modified Rankin Scale (UW-mRS) is an outcome measure recently proposed to improve statistical efficiency and interpretability of the mRS. Statistical properties of the UW-mRS have been well investigated, but construct validity has yet to be established.

Aims

To investigate the construct validity of the UW-mRS as a primary outcome measure by assessing variability in utility values within and between mRS categories, over time post-stroke, and by different derivation methods.

Methods

UW-mRS was derived using assessment of quality of life (AQoL-4D) and mRS scores at 3 and 12 months (n = 2030) from a large randomized controlled trial, A Very Early Rehabilitation Trial (AVERT). Receiver operator characteristic (ROC) analysis of AQoL-4D was conducted to differentiate between sequential mRS categories. Intraclass correlation was used to explore variability in utility values over time post-stroke, UW-mRS values, and derivation methods from multiple studies.

Results

UW-mRS values for mRS categories 0–6 at three months were 0.80, 0.78, 0.63, 0.37, 0.11, 0.03, and 0. Based on AQoL-4D utility values, areas under the ROC curve varied from 0.54 to 0.87. Time post-stroke explained 42%–56% of variability in AQoL-4D utility values in patients with no change in mRS between 3 and 12 months. The choice of the derivation method contributed to 25% of the variability in UW-mRS values. (Whatever this gobbledegook means. Obviously not meant for layperson survivors. If you can't explain this to normal people you have failed in your research.)

Conclusions

The high variability in utility values between and within mRS categories, over time post-stroke, and using different derivation methods is not adequately reflected in the UW-mRS. These threats to construct validity warrant caution when using UW-mRS as a primary outcome measure.

Trial registration

Australian New Zealand Clinical Trials Registry (ACTRN12606000185561

EFFECT OF DELAYED POST-STROKE REHABILITATION PROGRAM ON PATIENT'S FUNCTIONAL OUTCOME

Nothing here suggests that delayed admission causes poorer outcomes. Much more likely that they had worse strokes. This could have been determined if an objective damage diagnosis was done. I blame the mentors and senior researchers for not having the research set up properly.  FIM is pretty much useless since it is subjective.

EFFECT OF DELAYED POST-STROKE REHABILITATION PROGRAM ON PATIENT'S FUNCTIONAL OUTCOME

 Noreen Akhtar, Atif Ahmed Khan * , Aisha Ayyub ** Armed Forces Institute of Regenerative Medicine/National University of Medical Sciences (NUMS) Rawalpindi Pakistan, * Combined Military Hospital Kohat /National University of Medical Sciences (NUMS) Pakistan, ** KMU Institute of Medical Sciences (KIMS) Kohat Pakistan

ABSTRACT 

Objective: To examine the effects of delayed admission to rehabilitation on functional outcomes in post stroke patients. Study Design: Observational study . Place and Duration of Study: Department of Physical Medicine and Rehabilitation of Combined Military Hospital Kohat , from Sep 2016 to Sep 2017.
Material and Methods: A total of 55 patients with age ranging from 20 - 80 years who were diagnosed with first ever stroke and reported within 150 days of the onset of stroke to rehabilitation setup were selected through non-probability purposive sampling. The patients were divided into 2 groups as early (group - A ≤ 30 days) and delayed admission group (group - B=30 - 150 days) based on the length of time from stroke onset to admission to inpatient rehabilitation facility . Reasons for delay admission were identified and noted. Functional independence measure (FIM) score was used to assess functional status of the patient at admission. Patients in both groups underwent identical eight weeks of regular rehabilitation program with therapy sessions 3 hours a day, 5 days a week. Functional independence measure score was noted again at eight week of indoor rehabilitation. Results: Total 52 patients completed the study with 27 (51.9%) male and 25 (48.1%) female. Lack of awareness of Rehabilitation was the most common patient related factor found in 11 (34.4%) while Lack of caregiver support was most common external factor reported in 6 (18.7%). The patients with early admission to inpatient rehabilitation facility had a better functional independent measurement scores gain than the patients with delayed admission to inpatient rehabilitation facility (40.4 ± 11.4 vs. 11.9 ± 8.4, p =0.01) . However, FIM scores at admission in both groups were not statistically significant.
Conclusion: Delayed admission to inpatient rehabilitation facility after stroke event caused poorer functional outcomes in stroke patients.

Accuracy vs. Reproductibility in the National Institutes of Health Stroke Scale: When the NIHSS Does Not Assess All the Symptoms

You still don't know that the NIHSS subjective stroke scale is worthless? You can't do a goddamn thing with it; map recovery protocols to a objective starting point. No research is reproducible using this since it has nothing objective in it.

 

Accuracy vs. Reproductibility in the National Institutes of Health Stroke Scale: When the NIHSS Does Not Assess All the Symptoms

Elena Zapata-Arriaza, MD
@ElenaZaps

Eskioglou E, Huchmandzadeh Millotte M, Amiguet M, Michel P. National Institutes of Health Stroke Scale Zero Strokes: Immeasurable but Not Innocent. Stroke. 2018
The National Institutes of Health Stroke Scale (NIHSS) is the most widely employed deficit rating scale in modern neurology and has became the gold standard for stroke severity rating in recent published clinical trials. However, it is essential to know that the scale was not designed to serve as a bedside rating tool for widespread use outside of research trials. The goal of NIHSS is to assure reproducibility, not accuracy.
The authors performed a retrospective analysis of all acute ischemic stroke patients admitted to the stroke unit and intensive care unit of the Lausanne University Hospital from 2003 to 2013. The main goal of this paper was to highlight the characteristics of ischemic strokes with a NIHSS = 0, as well as to determine the long-term evolution of these patients. The originality of the paper is the aim itself, which makes us wonder whether the NIHSS is a sufficiently accurate scale to determine the severity of all ischemic strokes. The authors included all patients with a suspected stroke according to the classical World Health Organization definition. The sample was divided between NIHSS=0 and NIHSS > or equal to 1, and brain and vascular state was assessed mostly by computed tomography. During follow-up, mortality, stroke or transient ischemic attack recurrence and functional outcome (3 and 12 months) were collected.

Among 2997 included patients, 108 had a NIHSS=0. After multivariate analysis, NIHSS=0 subgroup patients showed statistically significant differences. The main findings are displayed in the Table below. The most outstanding clinical and radiological findings related to NIHSS=0 strokes were a lower prestroke disability, a delay in hospital arrival, lacunar and infratentorial presentation, higher ASPECTS at admission and less arterial stenosis or occlusion.

Two NIHSS=0 patients died within 3 months from early stroke recurrence, and 5 others after 12 months (2 cancers, 1 pneumonia, 2 undetermined causes). Favorable outcome was clearly more frequent in NIHSS=0 patients. Recurrence rates were similar for strokes (6.6% in NIHSS=0 versus 8.8% in NIHSS ≥1) and for strokes and TIAs combined (11.4% versus 11.0%). About 28.5% NIHSS=0 patients had unfavorable 3 months outcome (mRS score of ≥2), and 46.7% had some remaining symptoms or handicap (mRS score of ≥1), mostly related in the multivariate analysis with infratentorial stroke localization and acute cerebellar symptoms.
Interesting assessment can be obtained from this paper. First, the NIHSS scale may be insufficient to detect certain neurological deficits with prognostic and functional implications. There may be patients with an NIHSS = 0 and disability in the post-stroke follow-up. This powerful message reveals the limitations in the clinical accuracy of a scale created to be reproducible and whose main application field are clinical trials. Likewise, the persistence of disability associated with cerebellar symptoms and stroke in the posterior territory highlights the underestimation of the NIHSS scale in this stroke localization. To determine a stroke patient’s severity, the complete and properly described neurological examination is closer to the real clinical patient state, and therefore will better guide us to the future evolution of the patient.
Secondly, the recurrence of stroke is similar in both subgroups, although patients with NIHSS = 0 have a CT without alterations. This should alert us to the following: Clinical examination is always the starting point that should lead the management and clinical follow-up. Patients with a non-quantifiable deficit are at risk of recurrence and deserve secondary prevention and adequate follow-up.
Finally, it is important to note that in this article, the image analysis is performed mainly by CT. Such assessment could misdiagnose mimics as strokes; MRI could identify situations where symptoms are not due to vascular causes. In any case, it is important to emphasize that the NIHSS is not infallible, and it must be taken into account the aim of its origin, which was reproducibility, not clinical accuracy.