A User-friendly, Non-invasive Neuro-orthosis That Restores Volitionally Controlled Grasp Functions for SCI Survivors With Tetraplegia

NARecruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 31, 2023

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2025

Conditions
Cervical Spinal Cord Injury
Interventions
DEVICE

NeuroLife EMG-FES Sleeve System

Participants will complete a 12-week training protocol (3x/week, 1-2 hours/session) which includes an activity-based upper extremity training paradigm where participants will complete multiple repetitions attempting functional tasks in different categories (grip, grip with rotation, pinch, and pinch with rotation) while using the closed-loop EMG-FES system on one forearm/hand. Each category includes \~10 functional tasks (e.g., grip - open a jar; pinch with rotation - nuts and bolts) that progressively increase in difficulty. Each session will include massed practice of 3 functional tasks (20-minute blocks for each task) with rest breaks as needed to avoid fatigue. Sessions will include \~60 minutes of task practice, but they may last 1-2 hours to account for setup time and rest breaks.

Trial Locations (2)

43201

RECRUITING

Battelle Memorial Institute, Columbus

43210

RECRUITING

Ohio State University Wexner Medical Center (Columbus Campus, Dodd Hall, Martha Morehouse Medical Pavillion), Columbus

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Battelle Memorial Institute

OTHER

lead

Ohio State University

OTHER