About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Veteran
Age 18-65
All gender, any ethnicity
Cervical Spinal Cord Injury C2-8
Disqualifiers
Cardiopulmonary disease or cardiac symptoms,
Autonomic dysreflexia that is uncontrolled or severe,
Implanted medical device(s),
Uncontrolled spasms that could limit participation in exercise training,
Trial design
Single group
Treatments tested in this trial
transcutaneous Spinal Cord Stimulation (tSCS)
BehavioralNeurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement.
Treatment groups
Trial outcomes
Primary outcomes
NASA-TLX (NASA Task Load Index)
Measures subjective mental work load \& physical effort
QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology)
Measures usability of device (eg, adjustability, comfort, safety and effectiveness)
Secondary outcomes
GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension)
Measures upper limb sensation, strength, and prehension
CUE-Q (Capabilities of Upper Extremity Function)
Measures functional limitation and difficulty in performing upper limb activities
DASH (Disabilities of the Arm, Shoulder, and Hand)
Measures upper limb function during ADL tasks, work activities, recreational sports, and pain-related limitations
COPM (Canadian Occupational Performance Measure)
Measures performance \& satisfaction of self-identified activities in self-care, productivity and leisure
Sponsors and contacts
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VA Palo Alto Health Care System
Lead sponsor
ONWARD Medical, Inc.
Collaborator
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