GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.
Stroke, Gait, Hemiplegic, Hemiplegia
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Gait, Falls
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
- Women who are pregnant
Sites / Locations
- Spaulding Rehabilitation Hospital BostonRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivors
Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors
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.
The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.