Gait Perturbations to Improve Balance Post-stroke

Study Overview
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Brief Summary
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Individuals with stroke have balance and gait deficits. Gait training does improve balance and gait abilities, but adding perturbations may have increase these effects. The objective was to compare the effect gait training with and without perturbations on balance and gait abilities in individuals with hemiparesis due to stroke at a chronic stage.

Official Title
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Unpredictable Perturbations During Gait to Improve Balance Performance, Confidence and Participation in Persons With Hemiparesis at a Chronic Stage: a Pilot Study

Conditions
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Hemiparesis;Poststroke/CVA

Intervention / Treatment
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* Device: Gait training with perturbations
* Device: Gait training without perturbation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to walk at a comfortable speed less than 1.0 m/s have reduced dynamic balance capacities (as evaluated by the mini-BESTest; score below the 95% confidence interval of the mean score of the corresponding age group of normative data) with or without a history of fall be able to walk on a treadmill, without external support, such as handrails or walking aid, for at least 1 minute Exclusion Criteria: hemineglect (more than 6 omissions on the bell cancellation test), cognitive impairment (Mini-Mental State Examination score under 24/30) uncorrected visual deficit or pathologies other than stroke which can affect their gait or balance

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Only the experimental intervention was offered in the second phase of the trial, to the participants who received the control intervention in the first phase
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gait training without perturbation<br>Walking on a treadmill with the same duration as a participants of the experimental arm matched for initial gait speed. Treadmill speed did not change along the training program | Device: Gait training without perturbation<br>* Walking on a treadmill with steady belt speed<br>|
| Experimental: Gait training with perturbations<br>Walking on a treadmill with perturbations produced by changes in the speed of one of the belt of the split-belt treadmill during one gait cycle. Changes in treadmill speed were applied on the paretic or non-paretic side, with and increase or a decrease of the speed of the belt in various magnitude. Perturbations were either repeated with the same characteristics or with different characteristics. Outside of perturbations, treadmill speed did not change along the training program. | Device: Gait training with perturbations<br>* Changes in speed of one of the belt of the split belt treadmill during swing phase<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance capacities | Score at the mini-Balance Evaluation System Test (mini-BESTest). Score between 0 and 28. Higher scores associated with better balance abilities. | Within the week pre-training | 
| Balance capacities | Score at the mini-Balance Evaluation System Test (mini-BESTest). Score between 0 and 28. Higher scores associated with better balance abilities. | Within the week post-training | 
| Gait capacities | Self-selected and fast gait speed measured over 10 meters (10 meter walking test) | Within the week pre-training | 
| Gait capacities | Self-selected and fast gait speed measured over 10 meters (10 meter walking test) | Within the week post-training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paretic and non-paretic maximal knee extensor strength | Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex). | Within the week pre-training | 
| Paretic and non-paretic maximal knee extensor strength | Measure of isometric, maximal knee extensor strength at each knee, using an instrumented dynamometer (Biodex) | Within the week post-training | 
| Balance confidence | Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence | Within the week pre-training | 
| Balance confidence | Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence | Within the week post-training | 
| Balance confidence | Score at the Activity-specific Balance Confidence (ABC scale), between 0 and 100%, with 100% indicating better balance confidence | 6 weeks post training | 
| Community reintegration | Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration. | Within the week pre-training | 
| Community reintegration | Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration. | Within the week post-training | 
| Community reintegration | Score at the Reintegration to Normal Living Index (RNLI), between 0 and 22, with 0 indicating total reintegration. | 6 weeks post training |