Multi-center, single-blind randomized controlled trial comparing functional electrical stimulation therapy to...

Area of Science:

• Neuroscience
• Rehabilitation Medicine
• Biomedical Engineering

Background:

• Tetraplegia leads to significant upper extremity functional loss.
• Functional electrical stimulation (FES) therapy shows promise in pilot studies for enhancing upper limb function recovery.
• FES therapy may offer a novel approach to improving quality of life for individuals with spinal cord injuries.

Purpose of the Study:

• To evaluate the effectiveness of FES therapy delivered by the MyndMove stimulator in adults with tetraplegia.
• To compare FES therapy outcomes against conventional therapy for upper extremity function.
• To determine if FES therapy leads to statistically significant improvements in self-care abilities.

Main Methods:

• A multi-center, single-blind, randomized controlled trial involving adults with C4-C7 traumatic incomplete tetraplegia.
• Participants received either 40 sessions of FES or conventional therapy over 14 weeks.
• Outcomes were assessed using the Spinal Cord Injury Independence Measure (SCIM III), Hand Function Test, and Strength, Sensibility, and Prehension assessments.

Main Results:

• 51 participants were randomized; 27 received FES and 24 received conventional therapy.
• Both groups demonstrated a clinically meaningful mean improvement of 2 points in SCIM III-Self-Care scores.
• No statistically significant differences in outcomes were observed between the FES and conventional therapy groups.

Conclusions:

• Forty sessions of MyndMove FES therapy are as effective as conventional therapy for achieving persistent, meaningful functional improvements in upper extremity function.
• The study highlights the potential of FES as a viable therapeutic option for tetraplegia.
• Limitations include recruitment challenges due to COVID-19 and protocol modifications for some participants.