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Behavioural Intervention
Treadmill gait training with GaitBetter for Stroke
N/A
Waitlist Available
Led By Paolo Bonato, PhD
Research Sponsored by Spaulding Rehabilitation Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline scores at post-intervention (after 5 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests the GaitBetter system, a tool to help stroke survivors improve their walking and thinking abilities. It focuses on people who have had a stroke and struggle with these functions. The system uses exercises to enhance both movement and mental skills.
Eligible Conditions
- Stroke
- Hemiplegia
- Hemiplegic Shoulder Subluxation
- Hemiplegic Gait
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline scores at post-intervention (after 5 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline scores at post-intervention (after 5 weeks)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
10 meter walk test (in chronic stroke survivors, Aim 2)
10 meter walk test (in subacute stroke survivors, Aim 3)
Aim 3: Balance Evaluation Systems Test (mini-BESTest, in subacute stroke survivors, Aim 3)
+3 moreSecondary study objectives
Cerebrovascular accident
Stance time (in subacute stroke survivors, Aim 3)
Step length (in chronic stroke survivors, Aim 2)
+7 moreOther study objectives
12-Item Short Form Health Survey (SF-12) (in chronic stroke survivors, Aim 2)
Cerebrovascular accident
2-minutes walk test (2mwt) (in chronic stroke survivors, Aim 2)
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivorsExperimental Treatment2 Interventions
The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.
Group II: Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivorsExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Spaulding Rehabilitation HospitalLead Sponsor
139 Previous Clinical Trials
11,025 Total Patients Enrolled
25 Trials studying Stroke
886 Patients Enrolled for Stroke
GoldenGait LTDUNKNOWN
Paolo Bonato, PhDPrincipal InvestigatorHarvard Medical School (HMS and HSDM)
22 Previous Clinical Trials
642 Total Patients Enrolled
10 Trials studying Stroke
247 Patients Enrolled for Stroke
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