GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Spaulding Rehabilitation Hospital
- Enrollment
- 76
- Locations
- 1
- Primary Endpoint
- 10 meter walk test (in chronic stroke survivors, Aim 2)
- Last Updated
- 3 years ago
Overview
Brief Summary
In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.
Detailed Description
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.
Investigators
Paolo Bonato
Principal Investigator, Director of the Motion Analysis Laboratory
Spaulding Rehabilitation Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
10 meter walk test (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait speed of chronic stroke survivors, in meters per second
10 meter walk test (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait speed of subacute stroke survivors, in meters per second
Trail making test (in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of cognition status, in chronic stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Trail making test (in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of cognition status, in subacute stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Balance Evaluation Systems Test (mini-BESTest, in chronic stroke survivors, Aim 2)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Comprehensive evaluation of balance and falls risks in chronic stroke survivors. Score from 0 to 108. Higher scores are reflecting better balance
Aim 3: Balance Evaluation Systems Test (mini-BESTest, in subacute stroke survivors, Aim 3)
Time Frame: Change from baseline scores at post-intervention (after 5 weeks)
Comprehensive evaluation of balance and falls risks in subacute stroke survivors. Score from 0 to108. Higher scores are reflecting better balance
Secondary Outcomes
- Step length (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Step length (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))
- Step width (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Step width (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))
- Step symmetry (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Step symmetry (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))
- Stance time (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Stance time (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))
- Swing time (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Swing time (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))