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| Name | Class |
|---|---|
| GoldenGait LTD | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivors | Experimental | 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. |
|
| Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors | Experimental | The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treadmill gait training with GaitBetter | Device | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) (in chronic stroke survivors, Aim 2) | Measure of the cognitive status in chronic stroke survivors | Change from baseline scores at post-intervention (after 5 weeks) |
| Montreal Cognitive Assessment (MoCA) (in subacute stroke survivors, Aim 3) |
Inclusion Criteria:
Male and females of age between 18 to 85 year of age
History of one-sided ischemic or hemorrhagic stroke
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:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Bonato, PhD | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital Boston | Boston | Massachusetts | 02129 | United States |
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| Treadmill gait training with GaitBetter + Standard of care | Other | 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. |
|
| Standard of care | Other | Participants will follow their standard of care. The investigators will record the number and duration of therapy sessions followed during standard of care. |
|
| 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) |
| 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) |
Measure of the cognitive status in subacute stroke survivors |
| Change from baseline scores at post-intervention (after 5 weeks) |
| Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 2) | Measure of the cognitive status in chronic stroke survivors | Change from baseline scores at post-intervention (after 5 weeks) |
| Symbol-Digit Modalities Test (SDMT) (in subacute stroke survivors, Aim 3) | Measure of the cognitive status in subacute stroke survivors | Change from baseline scores at post-intervention (after 5 weeks) |
| Hopkins Verbal Learning Test (Revised) (in chronic stroke survivors, Aim 2) | Measure of the cognitive status in chronic stroke survivors | Change from baseline scores at post-intervention (after 5 weeks) |
| Hopkins Verbal Learning Test (Revised) (in subacute stroke survivors, Aim 3) | Measure of the cognitive status in subacute stroke survivors | Change from baseline scores at post-intervention (after 5 weeks) |
| 2-minutes walk test (2mwt) (in chronic stroke survivors, Aim 2) | Measure of the gait endurance in chronic stroke survivors | Change from baseline scores at post-intervention (after 5 weeks) |
| 2-minutes walk test (2mwt) (in subacute stroke survivors, Aim 3) | Measure of the gait endurance in subacute stroke survivors | Change from baseline scores at post-intervention (after 5 weeks) |
| Functional Gait Assessment (FGA) (in chronic stroke survivors, Aim 2) | Measure of the gait mobility, balance and falls risks in chronic stroke survivors | Change from baseline scores at post-intervention (after 5 weeks) |
| Functional Gait Assessment (FGA) (in subacute stroke survivors, Aim 3) | Measure of the gait mobility, balance and falls risks in subacute stroke survivors | Change from baseline scores at post-intervention (after 5 weeks) |
| 12-Item Short Form Health Survey (SF-12) (in chronic stroke survivors, Aim 2) | Self-reported measure of quality of life | Change from baseline scores at post-intervention (after 5 weeks) |
| 12-Item Short Form Health Survey (SF-12) (in subacute stroke survivors, Aim 3) | Self-reported measure of quality of life | Change from baseline scores at post-intervention (after 5 weeks) |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D020233 | Gait Disorders, Neurologic |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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