Rehabilitation of motor impairments in patients after cerebral stroke in the early recovery period using a treadmill with biofeedback

 Send your competent? doctor after the EXACT PROTOCOL! Inability to do that IS PURE INCOMPETENCE!

Rehabilitation of motor impairments in patients after cerebral stroke in the early recovery period using a treadmill with biofeedback

• Authors: Akhmadeeva L.R.¹, Goldyrev E.O.¹, Bagautdinov K.F.¹, Blinova N.M.¹
• Affiliations:
  1. Bashkir State Medical University
• Issue: Vol 11, No 2 (2026)
• Pages: 111-116
• Section: Neurology
• Published: 28.03.2026
• URL: https://innoscience.ru/2500-1388/article/view/704173
• DOI: https://doi.org/10.35693/SIM704173
• ID: 704173

Abstract

Aim: to evaluate the clinical effectiveness of integrating treadmill training with a biofeedback (BFB) system into an early post-stroke rehabilitation program for managing motor disorders and improving functional outcomes.

Material and methods. The study involved 60 patients during the first 6 months after ischemic stroke. Participants were randomized into two groups: the main (experimental) group and the control group. Both groups received standard comprehensive therapy, including physiotherapy, mechanotherapy, and occupational therapy. The main group additionally underwent a course of treatment on a treadmill with BFB (Walker View), which provided feedback on parameters of the support reaction and step symmetry. For an objective assessment of dynamics, a set of clinical scales (Timed Up and Go test, 10-meter walk test, Berg Balance Scale) and instrumental analysis of gait parameters (walking speed, step length) were used. The assessment was conducted before and after a 14-day rehabilitation course.

Results. The conducted study demonstrated a statistically significant improvement in all assessed parameters in both groups, confirming the effectiveness of standard rehabilitation. However, in the main group where BFB was applied, the dynamics of improvement were better. A comparative analysis showed that these patients achieved a more pronounced reduction in the time taken to complete the “Timed Up and Go” (20% vs. 17%) and 10-meter walk tests (23.3% vs. 23.1%), a substantial increase in scores on the Berg Balance Scale (27.4% vs. 15.1%), as well as a significant increase in step length (41.2% vs. 27.3%) and no difference in walking speed.

Conclusion. The integrating treadmill training with biofeedback into an early post-stroke rehabilitation program increases the effectiveness of walking recovery compared to standard therapy. The method promotes improved gait symmetry, balance, increased speed and step length, ultimately leading to enhanced functional independence of patients. Further research is required to determine the clinical effectiveness of treadmill gait training with BFB in a larger sample of patients and with a longer follow-up.

Perceived importance of walking among hospitalized patients with stroke: a thematic analysis

 ABSOLUTELY FUCKING USELESS! You deliver EXACT REHAB PROTOCOLS! Don't you know anything about survivor requirements? 'Perceived' has nothing to do with getting recovered. DELIVER RECOVERY!

Perceived importance of walking among hospitalized patients with stroke: a thematic analysis

Shingo Mitsue 1† *

T

Tatsuya Ogawa 2

Y

Yuji Minamikawa 1,2

S

Shinichi Shimada 3



Shu Morioka 1,4*

• 1. Department of Neurorehabilitation, Graduate School of Health Sciences, Kio University, Nara, Japan

• 2. Department of Rehabilitation, Nishiyamato Rehabilitation Hospital, Nara, Japan

Abstract

Introduction: 

Improved walking ability is a common rehabilitation goal for individuals following a stroke.(WRONG! They want back to normal; 100% recovery! You're fired for using the tyranny of low expectations to dumb down survivor goals!) However, the reasons why hospitalized individuals with stroke consider walking to be important are not yet fully understood. This study aimed to elucidate the perceived importance of walking among hospitalized patients with stroke.

Methods: 

This qualitative study employed thematic analysis. Hospitalized individuals with stroke undergoing gait rehabilitation were purposively sampled to capture variation in sex, age, and walking ability. The participants underwent in-person semi-structured interviews regarding the importance of walking, which were audio-recorded, transcribed verbatim, and systematically coded to generate themes.

Results: 

A total of 19 patients participated in the study. Thematic analysis revealed six major themes. (1) Resumption of daily life: walking was perceived as essential for returning to pre-stroke activities and routines. (2) Health promotion and prevention of functional decline: participants viewed walking as important for maintaining health and preventing deterioration. (3) Uncomfortable walking: participants described physical and environmental challenges associated with walking. (4) Relationships with others: concerns were expressed about how walking difficulties might affect relationships with family and others. (5) Labeling of decreased walking ability: participants were conscious of how their walking was perceived by others. (6) Social environment: walking was linked to broader social factors such as work and transportation.

Conclusion: 

The importance of walking for hospitalized patients with stroke ranges from impersonal and generalizable reasons to highly individualized and diverse factors, with implications for individualized walking rehabilitation.

1 Introduction

Stroke is a sudden-onset condition, with approximately 80% of people who have experienced stroke experiencing impaired walking ability (1), with gait disturbance as one of the most critical issues (2). Currently, many stroke rehabilitation programs focus on enhancing the biomechanical and neurological aspects of individuals post-stroke (3). While such approaches offer structured methods for functional recovery, the use of standardized assessments and interventions may inadvertently limit the extent to which the preferences and values of people post-stroke are incorporated into their rehabilitation (4). Schoeb and Bürge (5) reported that individuals undergoing physical therapy desire to more actively express their opinions, goals, and preferences. For example, even when a person post-stroke sets “improving walking ability” as a goal, there may be underlying intentions, such as a desire to walk independently, safely, or with a more natural gait. This suggests a potential gap between clinical priorities and patients’ own hopes for recovery (6), indicating the possibility that even among healthcare professionals involved in gait rehabilitation, the perspectives of individuals post-stroke may not be fully captured. Therefore, for post-stroke gait recovery, it is necessary to not only examine the factors that affect walking ability, such as independence, speed, endurance, and quality, but also the relationship between walking performance and the environment (7), and to provide rehabilitation that considers the opinions and preferences of individuals regarding their gait post-stroke.

A report by Bohannon et al. (8) is frequently cited in studies on the importance of and preference for walking among individuals post-stroke. This study found that individuals post-stroke considered walking independence the most critical factor, followed by distance, appearance, and speed. In addition, Combs et al. (9) reported that individuals with chronic stroke tend to prioritize walking distance over walking speed during outdoor activities. Furthermore, a qualitative analysis of the reasons for preference for specific walking elements revealed that, in terms of walking distance, some participants desired engagement in community activities and social participation, whereas others wished to walk longer distances, even at a slower speed. Some participants prioritized walking speed because they wanted to reach their destination more quickly. These findings suggest that the perceived importance of walking among people post-stroke may vary depending on background factors, such as the lifestyle roles they wish to resume and the range of their desired activity. Although Bohannon et al. (8) identified which walking elements individuals post-stroke prioritize, the reasons behind these choices were not the main focus of the study. Similarly, although Combs et al. (9) highlighted walking distance and speed, the motivations for prioritizing other walking factors remain open for further investigation. Building on these valuable insights, additional research is needed to better understand why individuals consider walking important after stroke and how their individual backgrounds affect these preferences.

The subacute phase, commonly defined as the period from approximately 7 days to 6 months after stroke onset (10), is the primary period during which hospitalized people with stroke receive intensive rehabilitation. During this phase, the incorporation of walking training is recommended in clinical practice guidelines (11), and the assessment of multiple walking-related outcomes is also considered necessary (12). During this period, it is essential to support individuals in achieving the highest possible functional level through interventions focused on improving physical function, sensorimotor impairments, and activities of daily living (13, 14). In addition, individuals post-stroke seek to reconstruct their identities and roles in preparation for reintegration into society after hospital discharge (6). Thus, the period of inpatient rehabilitation for people post-stroke is positioned as a critical phase not only for focusing on physical recovery but also for exploring post-discharge life and reconstructing a way of life, considering the individual’s social context. Based on these findings, in addition to interventions aimed at improving the walking ability, approaches that incorporate the psychosocial aspects (15) of individuals post-stroke are required for gait rehabilitation. However, knowledge of such approaches is limited. Exploring the perceptions of walking among people post-stroke during this stage of rehabilitation could help improve the understanding of the broader meaning of walking ability, which may produce rehabilitation interventions that align with individual preferences and their perceived importance.

The importance of walking varies among stroke survivors, making qualitative methods well suited to exploring their values and experiences. Therefore, this study aimed to clarify why hospitalized individuals post-stroke perceive walking to be important during inpatient rehabilitation.

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Plasma cholinergic markers are associated with post-stroke walking recovery—revisiting the STROKEWALK study

But you gave us NOTHING ON HOW TO ASSIST IN GETTING PROPER BDNF LEVELS! Useless. I'd have you all fired!

 Plasma cholinergic markers are associated with post-stroke walking recovery—revisiting the STROKEWALK study

Sumonto Mitra1*†, Taher Darreh-Shori1, Erik Lundström2†, Staffan Eriksson3,4,5†, Tommy Cederholm6, Maria Eriksdotter1,7 and Birgit Vahlberg3*†

1Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Karolinska Institutet, Center for Alzheimer Research, Huddinge, Sweden

2Department of Medical Sciences, Neurology, Uppsala University, Uppsala, Sweden

3Department of Public Health and Caring Sciences, Geriatrics, Uppsala University, Uppsala, Sweden

4Centre for Clinical Research, Sörmland, Uppsala University, Eskilstuna, Sweden

5Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden

6Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, Uppsala, Sweden

7Theme Inflammation and Aging, Karolinska University Hospital, Huddinge, Sweden

Edited by

Haipeng Liu, Coventry University, United Kingdom

Reviewed by

Nazareno Paolocci, Johns Hopkins University, United States

Patricia Concepción García Suárez, University of Kansas, United States

Maria Luisa Garo, Mathsly Research, Italy

Abdur Raheem Khan, Integral University, India

*Correspondence

Birgit Vahlberg, birgit.vahlberg@pubcare.uu.se; Sumonto Mitra, Sumonto.mitra@ki.se

†ORCID

Sumonto Mitra, orcid.org/0000-0001-6381-5344

Erik Lundström, orcid.org/0000-0002-5313-9052

Staffan Eriksson, orcid.org/0000-0003-3572-8918

Birgit Vahlberg, orcid.org/0000-0002-1508-1435

Received 10 March 2025

Accepted 14 May 2025

Published 30 May 2025

Citation

Mitra S, Darreh-Shori T, Lundström E, Eriksson S, Cederholm T, Eriksdotter M and Vahlberg B (2025) Plasma cholinergic markers are associated with post-stroke walking recovery—revisiting the STROKEWALK study. Front. Neurol. 16:1568401. doi: 10.3389/fneur.2025.1568401

Introduction: Optimizing post-stroke rehabilitation strategies remains imperative for improving patient outcomes. Physical exercise, including outdoor walking, represents a promising intervention; however, its clinical efficacy, along with the utility of SMS-guided instructions to support adherence, requires further investigation. This study aims to elucidate the association of BDNF levels and cholinergic markers in the plasma of patients with previously reported post-stroke walking recovery (STROKEWALK study).

Methods: Post-stroke patients were randomly selected to receive SMS-guided exercise instructions (intervention group, n = 31) or not (control group, n = 31) at the time of stroke (baseline) and continued for the next 3 months. Plasma samples were collected at baseline (n = 28) and at 3-month follow-up (n = 28) and analyzed for Brain-Derived-Neurotrophic-Factor (BDNF) protein as a primary outcome. Secondary outcomes included enzyme activities of choline acetyltransferase (ChAT) and Butyrylcholinesterase (BChE), and the six-minute walking test (6MWT), which was assessed at the same time as the plasma sampling.

Results: A significant decline in BDNF was observed at 3 months in the total population (n = 56), primarily driven by the control group. Stratifying groups as intervention or control displayed no significant difference in BDNF protein levels, nor in ChAT or BChE activities at baseline or at 3-month follow-up, except for a significant correlation between BChE and Body-Mass Index (BMI). Patient stratification based on 6MWT performance displayed higher BDNF levels in the intervention group versus the control group, especially among females but not males. Females showed higher BChE than the males in the control group, but not in the intervention. Interestingly, the change in ChAT activity and cholinergic index (ChAT/BChE) from baseline to follow-up is significantly correlated with 6MWT performance.

Discussion: We conclude that SMS-guided exercise training improves post-stroke walking performance (6MWT) which attenuates the decline in BDNF levels. Cholinergic function correlates with improved walking performance and could be a useful marker to evaluate rehabilitation outcomes.(Why the indirect step? Just ask the patient if they recovered 100% walking! See how simple this can be?)

Keywords
brain-derived neurotrophic factor (BDNF); stroke; cholinergic index; exercise; rehabilitation

Healthy older adults generate transverse-plane momenta required for 90° turns while walking during the same phases of gait as used in straight-line gait

Does your competent? doctor have your therapists measuring this and have available EXACT PROTOCOLS to bring your walking back to normal? NO? So you don't have a functioning stroke doctor, do you? Why are you seeing them?

Healthy older adults generate transverse-plane momenta required for 90° turns while walking during the same phases of gait as used in straight-line gait

• Mitchell Tillman,
• Jun Ming Liu,
• Zahava M. Hirsch,
• Janine Molino &
• Antonia M. Zaferiou 

Journal of NeuroEngineering and Rehabilitation volume 21, Article number: 145 (2024) Cite this article

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Abstract

Background

Generation and regulation (control) of linear and angular momentum is a challenge during turning while walking which may be exacerbated by age-related changes. In healthy older adults, little is known about how momentum is controlled during turns, especially within each phase of gait. Each phase of gait affords unique mechanical contexts to control momenta and regulate balance. In healthy young adults, we found that the transverse-plane linear and angular momenta generation strategies observed within specific phases of gait during straight-line gait were also used during turns. Therefore, in this study, we investigated whether healthy older adults shared similar momentum control strategies specific to each gait phase during straight-line gait and turns.

Methods

Nine healthy older adults completed straight-line gait and 90° leftward walking turns. We compared the change in transverse-plane whole-body linear and angular momentum across gait phases (left and right single and double support). We also compared the average leftward force and transverse-plane moment across gait phases.

Results

We found that leftward linear momentum was generated most during right single support in straight-line gait and leftward turns. However, in contrast to straight-line gait, during leftward turns, average leftward force was applied across gait phases, with left single support generating significantly less leftward average force than other gait phases. Leftward angular momentum generation and average moment were greatest during left double support in both tasks. We observed some within-participant results that diverged from the group statistical findings, illustrating that although they are common, these momenta control strategies are not necessary.

Conclusions

Older adults generated transverse-plane linear and angular momentum during consistent phases of gait during straight-line gait and 90° turns, potentially indicating a shared control strategy. Understanding momentum control within each phase of gait can help design more specific targets in gait and balance training interventions.

Introduction

Linear and angular momentum must be generated and regulated (i.e., controlled) in the transverse plane to walk in a straight-line and to navigate real-world environments that require turning while walking. To walk in daily life, these momenta must be controlled through multilayered sub-system controller actions (e.g., muscle torques, etc.) so that the destination is reached without a fall [1]. Notably, up to 50% of our daily steps are part of turning gait, depending on the environment [2], and turning challenges momenta control beyond the demands of straight-line gait [3]. In older adults, turns are more difficult to execute due to age-related physiological changes which affect momenta control, even in healthy older adults, such as declines in muscle strength and coordination [4].

Prior research has described linear and angular momentum patterns during straight-line gait in healthy young and older adults towards quantifying balance. In straight-line gait, linear momentum exhibits small oscillations about zero in the medial–lateral (ML) direction [5] as weight shifts from one footfall to the next. Other work has shown that angular momentum during straight-line gait is maintained near zero, oscillating about zero in each plane over the course of the gait cycle [1]. Coordinating linear and angular momenta in straight-line gait allows maintenance of a constant speed and direction while facilitating balance. In turns, less is known about the neuromechanics of momenta control.

In walking turns, transverse-plane linear and angular momentum must be redirected towards the new direction of travel [6]. Specifically, linear momentum must be generated in the new desired direction travel so that the center of mass (COM) trajectory can redirect. In the angular domain, angular momentum must be generated to rotate the body about a vertical axis passing through the COM to change the body’s facing direction. While there are few prior studies about how older adults’ momentum is controlled during turns, in young and middle aged healthy adults, transverse-plane linear momentum redirection has been shown to occur via medially directed forces over the course of the “outside” foot’s stance phase (e.g., right leg stance phase during leftward turn) [7,8,9]. During turns, transverse-plane angular momentum diverges from oscillating about zero [3] in order to achieve body rotation about vertical. For example, during a 90° turn, average transverse-plane angular momentum was greater than it was during straight-line gait [10].

Investigating momentum generation within each of the four phases of gait is helpful because each gait phase affords unique mechanical contexts and turning while walking can occur over multiple steps [2]. This detailed information can be used in future rehabilitative practices to help diagnose motor control disfunction and train momenta generation strategies specific to base of support contexts. For example, if axial body rotation and balance are facilitated when both legs are in contact with the ground, gait retraining approaches can provide more specific body rotation targets for double support gait phases. Using a framework to investigate the contribution of each gait phase to momenta control, in young adults we found indicators of momenta control strategies that were specific to each gait phase during seemingly disparate tasks [6]. Specifically, during straight-line gait, pre-planned and late-cued 90° leftward turns, leftward transverse-plane linear and angular momentum were primarily generated during right single support and left double support phases, respectively The mechanical context to generate linear and angular impulses differs greatly as the COM and base of support relationship changes between single and double support phases in bipedal locomotion. Thus, our previous findings in young adults suggest that they leverage transverse-plane linear and angular momenta control specific to the gait phases during both straight-line gait and walking turns, despite differences in momenta control demands and footfall patterns across these tasks [6].

The primary purpose of this study was to understand whether transverse-plane linear and angular momentum generation in older adults occurs during the same phases of gait in straight-line gait and 90° turns. We hypothesized that both the straight-line gait and 90° left turn tasks will exhibit (1) the largest increase in linear momentum (Δp_x) and average leftward force (F_x,avg) towards the new direction of travel during right single support vs. other gait phases, and (2) the largest leftward change in transverse-plane angular momentum (ΔH_z) and average moment (M_z,avg) during left double support vs. other gait phases.

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Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation

 

But you didn't ask or answer the most important question! 

Does this get them recovered enough to not need the orthosis? 

Horrendous research, I'd have you all fired! Survivors don't want compensation, they want RECOVERY!

Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation

• Rebecca Macaluso,
• Matt Giffhorn,
• Sara Prokup,
• Brice Cleland,
• Jusuk Lee,
• Bokman Lim,
• Minhyung Lee,
• Hwang-Jae Lee,
• Sangeetha Madhavan &
• Arun Jayaraman 

Journal of NeuroEngineering and Rehabilitation volume 21, Article number: 127 (2024) Cite this article

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Abstract

Objective

The objective of this study was to analyze the safety and efficacy of using a robotic hip exoskeleton designed by Samsung Electronics Co., Ltd., Korea, called the Gait Enhancing and Motivating System-Hip (GEMS-H), in assistance mode only with the poststroke population in an outpatient-rehabilitation setting.

Methods

Forty-one participants with an average age of 60 and average stroke latency of 6.5 years completed this prospective, single arm, interventional, longitudinal study during the COVID-19 pandemic. Significant modifications to the traditional outpatient clinical environment were made to adhere to organizational physical distancing policies as well as guidelines from the Centers for Disease Control. All participants received gait training with the GEMS-H in assistance mode for 18 training sessions over the course of 6–8 weeks. Performance-based and self-reported clinical outcomes were assessed at four time points: baseline, midpoint (after 9 training sessions), post (after 18 training sessions), and 1-month follow up. Daily step count was also collected throughout the duration of the study using an ankle-worn actigraphy device. Additionally, corticomotor excitability was measured at baseline and post for 4 bilateral lower limb muscles using transcranial magnetic stimulation.

Results

By the end of the training program, the primary outcome, walking speed, improved by 0.13 m/s (p < 0.001). Secondary outcomes of walking endurance, balance, and functional gait also improved as measured by the 6-Minute Walk Test (47 m, p < 0.001), Berg Balance Scale (2.93 points, p < 0.001), and Functional Gait Assessment (1.80 points, p < 0.001). Daily step count significantly improved with and average increase of 1,750 steps per day (p < 0.001). There was a 35% increase in detectable lower limb motor evoked potentials and a significant decrease in the active motor threshold in the medial gastrocnemius (-5.7, p < 0.05) after training with the device.

Conclusions

Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke. Day-to-day activity also improved as evidenced by increased daily step count. Additionally, corticomotor excitability changes suggest that training with this device may help correct interhemispheric imbalance typically seen after stroke.

Trial Registration

This study is registered with ClinicalTrials.gov (NCT04285060).

Introduction

Stroke is the leading cause of adult-onset disability in the United States. Up to 80% of stroke survivors experience considerable gait impairments, such as reduced walking speeds, reduced endurance, and asymmetrical walking patterns, resulting in limited capacity for community ambulation [1]. These mobility deficits are the result of a combination of numerous neuromuscular changes post stroke, including: reduced corticospinal drive and control [2], muscle atrophy and weakness [3], impaired balance and postural control [4], and abnormal muscle synergies [5].

The goal of post-stroke rehabilitation is to facilitate return to an individual’s highest level of function for employment and social and community participation [6]. The return of mobility and walking is a crucial part of this return to everyday function [7]. There is strong evidence that individuals who have had a stroke continue to recover years after the original neurological insult [8, 9]. Thus, continuing therapy as part of outpatient care or in home/community settings provides the opportunity for individuals with chronic stroke to continue to recover walking function. One group of technologies that shows promise in seamless integration with the outpatient and community settings are unconstrained, light-weight, modular, robotic exoskeletons. The use of these modular exoskeletons may allow intense gait training to be combined with activities of daily living. Furthermore, these robots can also target specific chronic impairments without sacrificing the functional task practice. However, there are a limited number of studies that investigate the impact of this technology on walking performance in the chronic stroke population in the outpatient, home, and/or community settings [10, 11]. More clinical studies are warranted to help provide evidence to guide this new generation of light-weight, modular robots to become part of everyday rehabilitation strategies.

The primary objective of this study was to analyze the safety and efficacy, as measured by clinical outcomes, daily step count, and corticomotor excitability, of using the Samsung Gait Enhancing and Motivating System-Hip (GEMS-H) in assistance mode with the poststroke population as part of an outpatient-rehabilitation program. The primary hypothesis was that subjects would demonstrate improved clinical outcomes, as well as higher daily step counts and increased corticomotor excitability, after completing 18 training sessions.

Customized passive-dynamic ankle–foot orthoses can improve walking economy and speed for many individuals post-stroke

 But you didn't ask or answer the most important question! 

Does this get them recovered enough to not need the orthosis? 

Horrendous research, I'd have you all fired! Survivors don't want compensation, they want RECOVERY!

Customized passive-dynamic ankle–foot orthoses can improve walking economy and speed for many individuals post-stroke

• Jacob T. Skigen,
• Corey A. Koller,
• Luke Nigro,
• Darcy S. Reisman,
• Zahra McKee,
• Shay R. Pinhey,
• Adrienne Henderson,
• Jason M. Wilken &
• Elisa S. Arch 

Journal of NeuroEngineering and Rehabilitation volume 21, Article number: 126 (2024) Cite this article

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Abstract

Background

Passive-dynamic ankle–foot orthoses (PD-AFOs) are often prescribed to address plantar flexor weakness during gait, which is commonly observed after stroke. However, limited evidence is available to inform the prescription guidelines of PD-AFO bending stiffness. This study assessed the extent to which PD-AFOs customized to match an individual’s level of plantar flexor weakness influence walking function, as compared to No AFO and their standard of care (SOC) AFO.

Methods

Mechanical cost-of-transport, self-selected walking speed, and key biomechanical variables were measured while individuals greater than six months post-stroke walked with No AFO, with their SOC AFO, and with a stiffness-customized PD-AFO. Outcomes were compared across these conditions using a repeated measures ANOVA or Friedman test (depending on normality) for group-level analysis and simulation modeling analysis for individual-level analysis.

Results

Twenty participants completed study activities. Mechanical cost-of-transport and self-selected walking speed improved with the stiffness-customized PD-AFOs compared to No AFO and SOC AFO. However, this did not result in a consistent improvement in other biomechanical variables toward typical values. In line with the heterogeneous nature of the post-stroke population, the response to the PD-AFO was highly variable.

Conclusions

Stiffness-customized PD-AFOs can improve the mechanical cost-of-transport and self-selected walking speed in many individuals post-stroke, as compared to No AFO and participants’ standard of care AFO. This work provides initial efficacy data for stiffness-customized PD-AFOs in individuals post-stroke and lays the foundation for future studies to enable consistently effective prescription of PD-AFOs for patients post-stroke in clinical practice.

Trial Registration: NCT04619043.

Background

Stroke is one of the leading causes of long-term disability, with more than 795,000 individuals in the United States experiencing a stroke each year [1]. Weakened plantar flexor muscles on the paretic limb is a common impairment after stroke [2, 3]. This weakness compromises the individual’s ability to control the lower leg's forward rotation during mid-to-terminal stance [2, 4, 5] and to generate forward propulsion during push-off [2, 5]. This impaired ankle function can result in kinematic deviations during stance including excessive ankle dorsiflexion [6] or persistent knee extension/hyperextension [5, 7]. Impaired ankle function also inhibits forward progression [5] by causing decreased gait speed [2, 5], shorter and asymmetric step lengths [8], and an increased metabolic cost of walking [9,10,11,12]. Poor walking economy has been linked to decreases in mobility and participation in daily activities [13, 14], which in turn have been shown to negatively impact both the physical [15,16,17] and mental [18] well-being of chronic stroke survivors.

Passive-dynamic ankle–foot orthoses (PD-AFOs) are a type of unpowered orthotic device that are gaining popularity for patients with neuromuscular impairments. PD-AFOs can be used to mitigate the negative effects on gait caused by weakened plantar flexors because they have a spring-like bending stiffness [19,20,21,22] that provides resistance to help control shank forward rotation during stance-phase dorsiflexion [23]. Additionally, as the PD-AFO deflects during the stance phase, it acts like a torsional spring by storing mechanical energy, which is returned during push-off to aid in forward progression [22]. In this way, PD-AFOs mimic many of the functions of healthy plantar flexor muscles. However, achieving optimal patient outcomes with PD-AFOs likely requires customizing the PD-AFO stiffness to provide personalized support for each individual [19, 24,25,26].

Despite the recognized need to match AFO characteristics to a patient’s needs [21], there is a lack of objective prescription guidelines to drive this matching for most, if not all, currently prescribed “standard-of-care” (SOC) AFOs. The lack of guidelines often results in an iterative trial-and-error approach to achieve a suitable PD-AFO strut stiffness, and results in substantial inconsistencies in the SOC AFOs that are currently provided. Such inconsistencies lead to varied and often limited patient outcomes for AFO users [24] likely due to a mismatch between orthosis characteristics and a patient’s needs [21].

Prior studies have begun to investigate the effects of PD-AFO stiffness on gait and propose methods for matching PD-AFO stiffness to patients’ needs, but there are still gaps in the knowledge. Pilot studies by our group examined the immediate effects of wearing a PD-AFO with the stiffness customized to make up for each individual’s level of plantar flexor weakness after stroke[19, 27]. The findings suggest customized PD-AFOs can increase the peak paretic plantar flexion moment, but results of other biomechanical and walking performance parameters were inconsistent [27]. Further, the prior studies did not examine more global outcome measures like cost-of-transport (COT) or orthosis satisfaction, and sample sizes were small. Other researchers have demonstrated that customizing PD-AFO stiffness can improve metabolic cost and gait speed compared to walking shod without an AFO and wearing an SOC AFO [24, 25, 28,29,30]. However, this research used a qualitative decision scheme to select one of five predetermined AFO stiffness values for each participant, based primarily on metabolic cost and gait speed outcomes, rather than utilizing an a priori prescription model. Further, this research did not include individuals with stroke. Multiple studies evaluating the effect of PD-AFO stiffness have been conducted in individuals post-limb salvage [31,32,33]; however given the many differences between the limb-salvage and post-stroke populations, results cannot be generalized across these populations. Thus, there is still insufficient evidence evaluating efficacy of a standardized, objective method for customizing PD-AFO stiffness to meet the individual needs of persons post-stroke.

The purpose of this study was to evaluate efficacy of stiffness-customized PD-AFOs in reducing total mechanical COT, improving self-selected walking speed (SSWS), improving gait biomechanics, and improving orthosis satisfaction compared to walking shod with no AFO and walking with their SOC AFO for individuals post-stroke. We hypothesized that walking with the PD-AFO would significantly decrease total mechanical COT, increase gait speed, improve gait biomechanics (towards typical), compared to walking with no AFO or their SOC AFO; and increase orthosis satisfaction compared to their SOC AFO. The findings of this study could provide evidence to inform the selection of PD-AFO stiffness and an important step toward establishing a standardized, objective prescription guideline for customizing PD-AFO stiffness to improve outcomes for individuals post-stroke.

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