Gait, Hemiplegic, Hemiplegia, Stroke
Conditions
Keywords
Stroke, Gait, Falls
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.
Interventions
DEVICETreadmill gait training with GaitBetter
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.
OTHERTreadmill gait training with GaitBetter + Standard of care
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.
OTHERStandard of care
Participants will follow their standard of care. The investigators will record the number and duration of therapy sessions followed during standard of care.
Sponsors
Spaulding Rehabilitation Hospital
GoldenGait LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10 meter walk test (in chronic stroke survivors, Aim 2) | 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) | 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) | 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) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Step length (in chronic stroke survivors, Aim 2) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait step length in chronic stroke survivors with an 3D motion capture system (in meters) |
| Step length (in subacute stroke survivors, Aim 3) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait step length in subacute stroke survivors with an 3D motion capture system (in meters) |
| Step width (in chronic stroke survivors, Aim 2) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait step width in chronic stroke survivors with an 3D motion capture system (in meters) |
| Step width (in subacute stroke survivors, Aim 3) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait step width in subacute stroke survivors with an 3D motion capture system (in meters) |
| Step symmetry (in chronic stroke survivors, Aim 2) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait step symmetry in chronic stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg) |
| Step symmetry (in subacute stroke survivors, Aim 3) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait step symmetry in subacute stroke survivors with an 3D motion capture system (ratio between paretic and non-paretic leg) |
| Stance time (in chronic stroke survivors, Aim 2) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait stance time in chronic stroke survivors with an 3D motion capture system (in seconds) |
| Stance time (in subacute stroke survivors, Aim 3) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait stance time in subacute stroke survivors with an 3D motion capture system (in seconds) |
| Swing time (in chronic stroke survivors, Aim 2) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait swing time in chronic stroke survivors with an 3D motion capture system (in seconds) |
| Swing time (in subacute stroke survivors, Aim 3) | Change from baseline scores at post-intervention (after 5 weeks) | Evaluation of gait swing time in subacute stroke survivors with an 3D motion capture system (in seconds) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPaolo Bonato, PhD
Harvard Medical School (HMS and HSDM)
Outcome results
None listed