GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.

Study Overview
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Brief Summary
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In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.

Detailed Description
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This study consists of 3 distinct aims: In Aim 1, the investigators will evaluate clinical acceptance of the GaitBetter solution by subjects and therapists. To do so, the investigators will run a pilot study to gather feedback from stakeholders (not reported here). In Aim 2, the investigators will evaluate the efficacy of using the GaitBetter solution to improve motor-cognitive function of chronic stroke survivors. To do so, the investigators will run a single-arm, non-randomized study to test the hypothesis that the GaitBetter training is effective in improving gait and cognition in individuals with chronic stroke. In Aim 3, the investigators will explore the efficacy of using the GaitBetter solution for improving rehabilitation outcomes in sub-acute stroke survivors. To do so, the investigators will run a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.

Official Title
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GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.

Conditions
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Stroke, Gait, Hemiplegic, Hemiplegia

Intervention / Treatment
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* Device: Treadmill gait training with GaitBetter
* Other: Treadmill gait training with GaitBetter + Standard of care
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females of age between 18 to 85 year of age History of one-sided ischemic or hemorrhagic stroke Chronic: more than 6 months post-stroke (Aim 1 and Aim 2) Subacute: within 8 weeks post-stroke (Aim 1 and Aim 3) Residual functional impairment of a lower extremity as a result of the stroke Ability to walk at least 15 meters with or without assistive devices (FIM walk subsection, levels 6 and 7) Ability to walk 3 consecutive minutes (5 minutes for Aim 2) on a treadmill at a speed equal to or greater than 0.22 m/s (0.8 km/h or 0.5 mph) with or without hand support. Medical clearance received from treating physician to participate in the gait training program proposed in the study Exclusion Criteria: Severe aphasia limiting the ability to express needs or discomfort verbally or non-verbally Cognitive impairment limiting the ability to understand and follow instructions (as assessed by a score <23 on the Mini Mental State Examination) Previous diagnosis of neurological diseases other than stroke Recent history of lower extremity fractures (<12 months ago), unhealed wounds Current indication for isolation precautions (e.g. MRSA, VRE, C. difficile, and others) Severe visual impairments (as assessed by the NIH Stroke Scale Visual Field subscale. score >0) Hemispatial neglect (as assessed by the Line Bisection Test) Subjects diagnosed with a medical condition that would interfere with their participation in regular sustained exercise (such as a severe pulmonary and/or cardiovascular condition) For Aim 2: currently participating in a gait training intervention (PT or research) Adults with impaired decision-making capacity Women who are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivors<br>The investigators propose a single-arm, non-randomized study to test the hypothesis that the GaitBetter training is effective in improving gait and cognition in individuals with chronic stroke. This design was chosen given the expected stability of functional recovery in this population. | Device: Treadmill gait training with GaitBetter<br>* Participants will receive gait training with the GaitBetter solution for a total of 15 sessions (3 days a week for 5 weeks) each lasting approximately 45 minutes.<br>|
| Experimental: Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors<br>The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory. | Other: Treadmill gait training with GaitBetter + Standard of care<br>* Participants will receive gait training with the GaitBetter solution for a total of 15 sessions (3 days a week for 5 weeks) each lasting approximately 45 minutes. In addition, the investigators will record the number and duration of therapy sessions followed by the participant during standard of care.<br>Other: Standard of care<br>* Participants will follow their standard of care. The investigators will record the number and duration of therapy sessions followed during standard of care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walk test (in chronic stroke survivors, Aim 2) | Evaluation of gait speed of chronic stroke survivors, in meters per second | Change from baseline scores at post-intervention (after 5 weeks) | 
| 10 meter walk test (in subacute stroke survivors, Aim 3) | Evaluation of gait speed of subacute stroke survivors, in meters per second | Change from baseline scores at post-intervention (after 5 weeks) | 
| Trail making test (in chronic stroke survivors, Aim 2) | Evaluation of cognition status, in chronic stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Trail making test (in subacute stroke survivors, Aim 3) | Evaluation of cognition status, in subacute stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Balance Evaluation Systems Test (mini-BESTest, in chronic stroke survivors, Aim 2) | Comprehensive evaluation of balance and falls risks in chronic stroke survivors. Score from 0 to 108. Higher scores are reflecting better balance | Change from baseline scores at post-intervention (after 5 weeks) | 
| Aim 3: Balance Evaluation Systems Test (mini-BESTest, in subacute stroke survivors, Aim 3) | Comprehensive evaluation of balance and falls risks in subacute stroke survivors. Score from 0 to108. Higher scores are reflecting better balance | Change from baseline scores at post-intervention (after 5 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step length (in chronic stroke survivors, Aim 2) | Evaluation of gait step length in chronic stroke survivors with an 3D motion capture system (in meters) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Step length (in subacute stroke survivors, Aim 3) | Evaluation of gait step length in subacute stroke survivors with an 3D motion capture system (in meters) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Step width (in chronic stroke survivors, Aim 2) | Evaluation of gait step width in chronic stroke survivors with an 3D motion capture system (in meters) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Step width (in subacute stroke survivors, Aim 3) | Evaluation of gait step width in subacute stroke survivors with an 3D motion capture system (in meters) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Step symmetry (in chronic stroke survivors, Aim 2) | Evaluation of gait step symmetry in chronic stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Step symmetry (in subacute stroke survivors, Aim 3) | Evaluation of gait step symmetry in subacute stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Stance time (in chronic stroke survivors, Aim 2) | Evaluation of gait stance time in chronic stroke survivors with an 3D motion capture system (in seconds) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Stance time (in subacute stroke survivors, Aim 3) | Evaluation of gait stance time in subacute stroke survivors with an 3D motion capture system (in seconds) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Swing time (in chronic stroke survivors, Aim 2) | Evaluation of gait swing time in chronic stroke survivors with an 3D motion capture system (in seconds) | Change from baseline scores at post-intervention (after 5 weeks) | 
| Swing time (in subacute stroke survivors, Aim 3) | Evaluation of gait swing time in subacute stroke survivors with an 3D motion capture system (in seconds) | Change from baseline scores at post-intervention (after 5 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Gait, Falls