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| Name | Class |
|---|---|
| Shirley Ryan AbilityLab | OTHER |
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A single-site, interventional, single-arm trial to evaluate the safety and efficacy on functional mobility following Samsung GEMS-H (Gait Enhancing and Motivating System - Hip) device training in participants with sub-acute and chronic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Training Group | Experimental | All participants are assigned to the training group with the Samsung GEMS-H. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Samsung GEMS-H | Device | Subjects will participate in 18 sessions of training in the outpatient clinic with a licensed physical therapist. Therapy sessions will include 30 minutes of task specific training and another 15 minutes of the session can be used to focus on patient specific goal areas related to functional mobility and balance. Training sessions will occur 2-3 times a week for 6-8 weeks to complete the training protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device related adverse events | Safety will be assessed by the number of device related adverse events throughout the duration of the study | Duration of study participation (estimated 6 months) |
| 10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) | Change in self-selected walking speed measured without the device | Baseline, Post-Intervention (estimated 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Test (6MWT) | Change in walking endurance measured without the device | Baseline, Post-Intervention (estimated 8 weeks) |
| Berg Balance Scale (BBS) | Changes in functional balance measured without the device |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device malfunctions | Device reliability will be assessed by the number of device malfunctions throughout the duration of the study | Duration of study (estimated 12 months) |
| ActiGraph activity monitor |
Inclusion Criteria:
Exclusion Criteria:
TMS-Specific Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arun Jayaraman, Ph.D. | Contact | +1-312-238-6875 | ajayaraman@sralab.org | |
| Kristen Hohl, DPT | Contact | +1-312-238-2640 | khohl@sralab.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Recruiting | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39080666 | Derived | Macaluso R, Giffhorn M, Prokup S, Cleland B, Lee J, Lim B, Lee M, Lee HJ, Madhavan S, Jayaraman A. Safety & efficacy of a robotic hip exoskeleton on outpatient stroke rehabilitation. J Neuroeng Rehabil. 2024 Jul 30;21(1):127. doi: 10.1186/s12984-024-01421-x. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Baseline, Post-Intervention (estimated 8 weeks) |
| Functional Gait Assessment (FGA) | Change in functional balance measured without the device | Baseline, Post-Intervention (estimated 8 weeks) |
Changes in average daily step count
| Duration of study participation (estimated 4 months) |
| Transcranial Magnetic Stimulation (TMS) | Measure changes in descending corticospinal drive to the lower limb muscles | Baseline, Post-Intervention (estimated 8 weeks) |
| 10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) | Changes in self-selected walking speed measured without the device | Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up) |
| 10 Meter Walk Test (Fastest walking speed) (10MWT-FS) | Changes in fastest walking speed measured without the device | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| 10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) with the device | Changes in self-selected walking speeds between two conditions (with and without the device) | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| 10 Meter Walk Test (Fastest walking speed) (10MWT-FS) with the device | Changes in fastest walking speeds between two conditions (with and without the device) | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| 6 Minute Walk Test (6MWT) | Changes in walking endurance measured without the device | Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up) |
| 6 Minute Walk Test (6MWT) with the device | Changes in walking endurance between two conditions (with and without the device) | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Berg Balance Scale (BBS) | Changes in functional balance measured without the device | Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up) |
| Functional Gait Assessment (FGA) | Change in functional balance measured without the device | Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up) |
| 5 Times Sit to Stand Test (5xSST) | Change in lower extremity strength measured without the device | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Gait analysis using a gait mat | Changes in spatiotemporal parameters measured without the device | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) | Changes in motor recovery measured without the device | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Manual Muscle Testing (MMT) | Changes in leg strength measured without the device | Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Modified Ashworth Test (MAS) | Changes in leg spasticity measured without the device | Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Passive Range of Motion (PROM) | Changes in passive range of motion in leg joints measured without the device | Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Modified Falls Efficacy Scale (mFES) | Changes in perception of balance and stability | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Activities-specific and Balance Confidence Scale (ABC) | Changes in confidence in performing various ambulatory activities without falling | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Stoke Impact Scale (SIS) | Changes in the measure of the impact of stroke on overall physical and cognitive function | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Patient Health Questionnaire-9 (PHQ-9) | Changes in depression | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Stroke Specific Quality of Life (SSQoL) | Changes in the health-related quality of life | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| Oxygen Consumption using Cosmed K4b2 | Changes in metabolic energy expenditure | Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |