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The purpose of this research study is to evaluate and compare different robotic exoskeletons (RE) and identify which is most appropriate for gait training for each patient based off their specific needs. This will help guide clinicians in prescribing the appropriate RE for rehabilitation.
This study will systematically compare various commercially available REs and aid in identifying the appropriate devices for gait training prescription in individuals post-stroke based on their deficits. The objective of this study is to evaluate and compare the four groups (3 REs and standard of care treatment) using biomechanical, functional and community participation & quality of life metrics. The robotic exoskeletons being used in this study are the AtalanteX (Wandercraft), Ekso NR (Ekso Bionics), and Restore (Lifeward).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stroke RE | Experimental | Participants in the stroke RE group will participate 3-4 weeks, 2-3 times a week for a total of 9 robotic exoskeleton gait training sessions provided by a trained, licensed physical therapist. |
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| Stroke SOC | Active Comparator | Participants in the stroke SOC group will participate 3-4 weeks, 2-3 times a week for a total of 9 standard of care gait training sessions provided by a trained, licensed physical therapist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Exoskeleton | Device | EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStoreâ„¢, Lifeward Inc, Marlborough, MA |
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| Measure | Description | Time Frame |
|---|---|---|
| 10MWT (Aim 1) | 10 meter walk test to evaluate walking speed after stroke and in response to the intervention. | Change from Baseline 10MWT at 4 weeks |
| 6MWT (Aim 1) | 6 minute walking test to evaluate endurance after stroke and in response to the intervention | Change from Baseline 6MWT at 4 weeks |
| TUG (Aim 1) | Timed up and go (TUG) test to measure functional balance and walking ability after stroke and in response to the intervention. | Change from Baseline TUG at 4 weeks |
| DGI (Aim 1) | Dynamic Gait Index (DGI) evaluates the ability to modify balance while walking in the presence of external demands after stroke and in response to the intervention. | Change from Baseline DGI at 4 weeks |
| Berg Balance Scale (Aim 1) | Measure to assess static and dynamic balance and fall risk after stroke and in response to the intervention. | Change from Baseline Berg at 4 weeks |
| Joint Range of Motion (kinematics) (Aim 2) | Kinematics gait data will be collected using a motion capture camera system to provide biomechanical outcomes. | Change from Baseline at 4 weeks |
| Temporospatial Loading (Aim 2) | Step length, timing during gait cycle, limb symmetry will be collected using instrumented gait walkway and insoles. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sharon Franco | Contact | 973-324-3521 | sfranco@kesslerfoundation.org | |
| Kathleen Goworek | Contact | 973-324-3560 | kgoworek@kesslerfoundation.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | West Orange | New Jersey | 07052 | United States |
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| ID | Term |
|---|---|
| D000067190 | Exoskeleton Device |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| SOC | Other | Standard of Care |
|
| Change from Baseline at 4 weeks |
| Balance (Aim 2) | Static and dynamic balance in standing and seated positions after stroke and in response to the intervention (using Hunova (Movendo Inc, Genova, Italy) plaform). | Change from Baseline at 4 weeks |
| Survey for Community Participation (Aim 3) | The Community Participation Indicators (CPI) is a self-reported 48 item objective measure survey. | Change from Baseline at 4 weeks |
| Survey for Quality of Life (Aim 3) | The SS-QOL survey assesses health-related quality of life (QOL) specific to stroke survivors with 49 items across 12 domains. | Change from Baseline at 4 weeks |