Clinical Trial of the Soft Extra Muscle Glove to Assess Orthotic and Long-Term Functional Gain Following Chronic Incomplete Tetraplegia: Preliminary Functional Results

Abstract

The soft extra muscle (SEM) Glove is a robotic hand device with the potential to serve as an orthotic and rehabilitation tool for people with spinal cord injury (SCI). In this longitudinal study 15 participants with a high neurological level (C2–C8) chronic SCI will be selected to trial the SEM Glove for 12 weeks at home to assist with activities of daily living (ADL). The participants will be scheduled to attend assessment sessions at Week 0 (Initial), Week 6, Week 12 and Week 18. Here we present progress with results related to grip strength and the Toronto Rehabilitation Institute hand function test (TRI-HFT) from eight participants who have completed the study. There was significant improvement in gross hand grip strength between Initial and Week 12 (p = 0.045). The TRI-HFT revealed significant improvement in hand function between Initial and, Week 6 (p ~ 0.01), Week 12 (p ~ 0.02). These results suggest that home use of devices designed to improve grip function has a direct effect on hand function.

Supported by Stoke Mandeville Spinal Research, Buckinghamshire Healthcare NHS Trust Charitable Fund. Bioservo AB, Anatomical Concepts UK LTD, Regain Sports Charity and the Rothschild Foundation.