NCT06349434

The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study.

Detailed description

Spinal cord injury (SCI) is a medically complex and life-disrupting condition. Each year in the United States, it is estimated that 17,700 new traumatic SCI cases are reported, including many active service men and women, and veterans. About half of those, the injury involve some part of the arm and hand, representing significant disability and dependence for those patients and their families. When arms/hands are impaired, the patient's quality of life and level of independence are reduced. The proposed RCT investigation will evaluate the long-term effects of the UE-MPWO (MyoPro) in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with SCI. This MyoPro orthosis can assist elbow and hand function with built-in motors that are activated by patients' intended motion, as represented by the residue voluntary muscle activities detected by the device's sensors. The impact of the data generated from this clinical trial investigation should advance the application of new orthotic and prosthetic technologies to treating disabilities as a result of injuries or diseases such as SCI and promote home and community uses of the technologies to improve daily function and independence. The study would also advance scientific knowledge regarding neural changes occurring in the nervous system by application of the technology. The learned knowledge from this investigation will further justify the utilization of such an orthotic technology for individuals with SCI. Beyond the common therapeutic benefits of upper extremity motor function rehabilitation and assistance for daily living provided with utilization of the MyoPro orthotic device, there may be additional benefits including improvements in quality of life and activity of daily living due to recovered function by using the device. The clinical trial investigation described in this application would provide clinicians and therapists with an initial, but stronger basis for integrating such an orthosis into regimens for managing upper extremity impairments in persons with SCI. This would represent a significant improvement to the existing paradigms of treating hand/arm disabilities in persons with SCI. The benefits, for the patients and society (including the VA community), of utilizing such an orthotic device during daily activities at home and in the community far outweigh the minimal risks associated with this FDA-approved orthosis, particularly as those minimal risks have been minimized by using sound research methodologies.

Conditions

• SCI - Spinal Cord Injury
• Upper Extremity Dysfunction
• Upper Extremity Problem

Interventions

Type	Name	Description
DEVICE	MyoMo	To evaluate the usefulness of extended utilization of an upper extremity assistive device, called (MyoPro) in improving upper extremity (UE) activities in people with spinal cord injury (SCI).
OTHER	conventional therapy	To evaluate the usefulness of extended conventional therapy compared to the utilization of an upper extremity assistive device called (MyoPro) in improving upper extremity (UE) activities in people with spinal cord injury.

Timeline

• Start date: 2023-10-15
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2024-04-05
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study