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| Name | Class |
|---|---|
| ONWARD Medical, Inc. | INDUSTRY |
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The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.
The overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (ONWARD, ARCex) while performing a prescriptive functional task based upper extremity home program for 2 months. Participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. Evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (QUEST 2.0, NASA-TLX) as well as participants ability to attend and complete all the training visits. Changes in upper extremity physical function will be measured using validated clinical tools (GRASSP, CUE-Q, DASH, COPM) as well as detailed evaluation of upper extremity muscle activation from surface EMG and strength measurements of pinch and grasp.
The primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tSCS plus home tele-video support | Experimental | Cervical transcutaneous spinal stimulation during home tele-video visits |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous Spinal Cord Stimulation (tSCS) | Behavioral | Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| NASA-TLX (NASA Task Load Index) | Measures subjective mental work load & physical effort | At 8 weeks (after completion of home program) |
| QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology) | Measures usability of device (eg, adjustability, comfort, safety and effectiveness) | At 8 weeks (after completion of home program) |
| Measure | Description | Time Frame |
|---|---|---|
| GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension) | Measures upper limb sensation, strength, and prehension | At entry (Baseline) and repeated at 8 weeks (after completion of home program) |
| CUE-Q (Capabilities of Upper Extremity Function) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Jaramillo, DPT | Contact | 650-493-5000 | 62286 | jeffrey.jaramillo@va.gov |
| Jenny Kiratli, PhD | Contact | 650-493-5000 | 65095 | jenny.kiratli@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Jenny Kiratli, PhD | VA Palo Alto Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D010243 | Paralysis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Measures functional limitation and difficulty in performing upper limb activities |
| At entry (Baseline) and repeated at 8 weeks (after completion of home program) |
| DASH (Disabilities of the Arm, Shoulder, and Hand) | Measures upper limb function during ADL tasks, work activities, recreational sports, and pain-related limitations | At entry (Baseline) and repeated at 8 weeks (after completion of home program) |
| COPM (Canadian Occupational Performance Measure) | Measures performance & satisfaction of self-identified activities in self-care, productivity and leisure | At entry (Baseline) and repeated at 8 weeks (after completion of home program) |
| D001519 | Behavior |