Did your stroke hospital have enough functioning brain cells to bring this in in 2014?
Bilateral
priming before Wii-based movement therapy enhances upper limb
rehabilitation and its retention after stroke: a case-controlled study 2014
Do you prefer your doctor and hospital incompetence NOT KNOWING? OR NOT DOING?
Bilateral priming is a rehabilitation adjuvant that can improve upper limb motor recovery poststroke.
It uses a table-top device to couple the upper limbs together such that
active flexion and extension of one wrist leads to passive movement of
the opposite wrist in a mirror symmetric pattern.
Bilateral upper extremity motor priming (BUMP) plus task-specific training for severe, chronic upper limb hemiparesis: study protocol for a randomized clinical trial
Trials volume 23, Article number: 523 (2022)
Abstract
Background
Various priming techniques to enhance neuroplasticity have been examined in stroke rehabilitation research. Most priming techniques are costly and approved only for research. Here, we describe a priming technique that is cost-effective and has potential to significantly change clinical practice. Bilateral motor priming uses the Exsurgo priming device (Exsurgo Rehabilitation, Auckland, NZ) so that the less affected limb drives the more affected limb in bilateral symmetrical wrist flexion and extension. The aim of this study is to determine the effects of a 5-week protocol of bilateral motor priming in combination with task-specific training on motor impairment of the affected limb, bimanual motor function, and interhemispheric inhibition in moderate to severely impaired people with stroke.
Methods
Seventy-six participants will be randomized to receive either 15, 2-h sessions, 3 times per week for 5 weeks (30 h of intervention) of bilateral motor priming and task-specific training (experimental group) or the same dose of control priming plus the task-specific training protocol. The experimental group performs bilateral symmetrical arm movements via the Exsurgo priming device which allows both wrists to move in rhythmic, symmetrical wrist flexion and extension for 15 min. The goal is one cycle (wrist flexion and wrist extension) per second. The control priming group receives transcutaneous electrical stimulation below sensory threshold for 15 min prior to the same 45 min of task-specific training. Outcome measures are collected at pre-intervention, post-intervention, and follow-up (8 weeks post-intervention). The primary outcome measure is the Fugl-Meyer Test of Upper Extremity Function. The secondary outcome is the Chedoke Arm and Hand Activity Index-Nine, an assessment of bimanual functional tasks.
Discussion
To date, there are only 6 studies documenting the efficacy of priming using bilateral movements, 4 of which are pilot or feasibility studies. This is the first large-scale clinical trial of bilateral priming plus task-specific training. We have previously completed a feasibility intervention study of bilateral motor priming plus task-specific training and have considerable experience using this protocol.
Trial registration
ClinicalTrials.gov NCT03517657. Retrospectively registered on May 7, 2018.
Administrative information
Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-defining-standard-protocol-items-for-clinical-trials/).
| Title {1} | Bilateral upper extremity motor priming (BUMP) plus task specific training for severe, chronic upper limb hemiparesis: Study protocol for a randomized clinical trial |
| Trial registration {2a and 2b} | ClinicalTrials.gov, ID: NCT03517657. Registered on May 7th, 2018. |
| Protocol version {3} | Version 14, July 14, 2021 |
| Funding {4} | This study is funded by grants from the NIH (1RO1HD091492-03) and NUCATS. The original funding documentation is contained in an Additional file (see Additional file 1). |
| Author details {5a} |
Mary Ellen Stoykov, PhD, OTR/L, Arms & Hands Lab, Shirley Ryan AbilityLab Department of Physical Medicine and Rehabilitation2 Feinberg School of Medicine Northwestern University Olivia M. Biller, OTD Department of Occupational Therapy Jefferson College of Rehabilitation Sciences Thomas Jefferson University Alexandra Wax, MS, OTR/L Think & Speak Lab, Arms & Hands Lab Shirley Ryan AbilityLab Erin King, MS, OTR/L Interdepartmental Institution of Neuroscience Northwestern University Jacob M. Schauer, PhD Department of Preventive Medicine – Division of Biostatistics Feinberg School of Medicine Northwestern University Louis F. Fogg, PhD Department of Occupational Therapy University of Illinois at Chicago Daniel M. Corcos, PhD Department of Physical Therapy and Human Movement Sciences Feinberg School of Medicine Northwestern University |
| Name and contact information for the trial sponsor {5b} |
Northwestern University 633 Clark Street Evanston, IL 60208 |
| Role of sponsor {5c} | All aspects of this study including trial design, methods of data collection, statistical analysis, interpretation of results, scientific writing, and dissemination are conducted independently from the study sponsor. |
Introduction
Background and rationale {6a}
The decline in stroke mortality over the twentieth century [1] has increased incidence of post-stroke disability, and the most common disability in the stroke population is upper extremity (UE) hemiparesis. Constraint-induced movement therapy (CIMT) is an effective intervention but is only appropriate for stroke survivors with mild UE impairment who are in the upper quartile of residual function [2]. Thus, alternative treatments are needed to target stroke survivors with more moderate and severe impairments of the UE, whose prognosis for motor recovery is less favorable.
In an observational study, Ward and colleagues [3] demonstrated a large improvement in the Fugl-Meyer Test of Upper Extremity Function (FMUE) median score (FMUEΔ 8.0, IQR=4–11) in severely impaired individuals after 90 h of various types of occupational therapy. While the improvement was impressive, the study did not inform about the superiority of any specific training. Also, 90 h of training is a very large dose that is not sustainable in the current healthcare climate in the USA. Other studies using unilateral training for individuals with severe UE impairment have shown improvements that can be described as modest at best including robotic training (FMUEΔ = 1.11 ± 1.01) [4]; unilateral task-specific training in an active comparator group (FMUEΔ = 3.1 ± 5.3) [5]; and task-specific training + robotics (FMUEΔ = +3.25 ± 1.68) [6]. These studies did not demonstrate an improvement in the FMUE of ≥ 4.25 which is the estimated clinically important difference [7]. More impaired individuals may need either a larger dose or an augmentative intervention.
Motor priming is a construct used to describe a variety of techniques that optimize the brain’s response to subsequent training and may enhance neuroplasticity and motor performance [8,9,10]. Shiner et al. [11] compared bilateral motor priming (BMP) plus Wii therapy to Wii therapy alone in subacute and chronic stroke subjects. The result was in favor of the bilateral priming plus Wii training group that, at follow-up, had a significantly greater mean FMUE [12] score than with Wii training alone (6.3 between-group difference) [11]. There was a large range of impairment levels in the Shiner et al. study, and those individuals with more severe impairment had the largest improvement. This result suggests that BMP may magnify improvements inherent in therapy protocols and facilitate sustained improvements over time in individuals with severe UE impairment. Stoykov and colleagues [13] used a task-specific training (TST) protocol and combined it with either BMP or stroke education (control). The bilateral priming group had a substantial increase in FMUE scores from pre-intervention to follow-up (FMUEΔ = 10 ± 6.1) while the improvement in the control group was modest (FMUEΔ = 3.56 ± 4.1.) These data were used as the pilot data for the grant submission.
Another priming + TST study examining UE hemiparesis in severely impaired participants used sensory-based priming plus TST [14] compared to TST alone, and the between-group differential of the FMUE was highest at follow-up (between-group FMUEΔ was 4.4 ± 1.1). This finding is consistent with other studies confirming that the largest difference between priming and control group is at follow-up [13,14,15,16,17,18].
This clinical trial examines the use of BMP, a non-invasive, cost-effective neuromodulation technique. BMP consists of continuous, bilateral wrist flexion and extension using a device with a mechanical linkage so that the less affected hand and the more affected one move in symmetry [19]. This study is a pivotal step towards developing and using a practical neuromodulatory technique to prime the central nervous system to respond with greater efficacy to behavioral interventions for people with moderate to severe UE hemiparesis. In addition to the benefits mentioned above and compared to priming using more invasive methods such as repetitive transcranial magnetic stimulation (rTMS), BMP is (1) cost-effective; (2) available to a larger pool of people due to the absence of safety concerns; (3) does not require a skilled operator; and (4) can potentially be implemented into the clinic [20]. There are no known risks to bilateral priming.
Objectives {7}
The purpose of this study is to test the hypothesis that bilateral symmetrical arm movements prime cortical regions and enhance neuroplasticity as measured by behavioral and cortical measures. Specifically, this trial will address two main objectives and test their associated hypotheses. The primary objective is to determine the magnitude of change in upper limb function and impairment in chronic stroke survivors who have undergone 30 h of BMP + TST. Primary hypothesis 1.1 is that the combination of BMP + TST will produce a between-group difference in improvement on the FMUE of at least 6.0 points more than control priming (CP) + TST at the follow-up timepoint (8 weeks post-treatment cessation). Secondary hypothesis 1.2 is that the combination of BMP + TST will increase scores on the Chedoke Arm & Hand Activity Index (CAHAI-9) by 3 points more than CP + TST, 8 weeks after the post-test (follow-up).
The secondary objective is to determine the effects of bilateral priming on cortical mechanisms measured by TMS. Hypothesis 2.1 is that BMP + TST will increase TCI from ipsilesional to contralesional hemisphere at post-treatment (following 30 h of treatment) and at 8 weeks after treatment cessation (follow-up), but there will be no change in the CP + TST group. Hypothesis 2.2 is that an increase in ipsilesional TCI will be positively associated with changes in the FMUE. We will perform a correlation analysis to test this relationship.
Trial design {8}
This protocol adheres to the guidance of the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement for reporting randomized clinical trials [21]. The study design is a stratified, randomized, masked, and parallel, two-arm intervention study of the effects of BMP and TST. This is a two-site superiority trial.
Methods: participants, interventions, and outcomes
Study setting {9}
Assessments are performed at the Northwestern University Department of Physical Therapy and Human Movement Science (PTHMS). Prior to the COVID-19 pandemic, treatment intervention and some of the assessments occurred at the Shirley Ryan AbilityLab. Northwestern University human subjects’ research was closed in March of 2020. Research resumed in July of 2020 but with significant restrictions specifying number of participants per research lab and strict adherence to protective equipment for both investigators and participants. Due to these restrictions, and preferences of the study team, the investigators decided to use both the Northwestern PTHMS Department and Shirley Ryan AbilityLab for treatment. Assessments are now only performed at Northwestern PTHMS Department. Both locations are in Chicago, Illinois.
