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

Technology
Arm/hand function
Online since 3 May 2024, updated 14 days ago

About this trial

To evaluate the usefulness of an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI). The Department of D...

Included participants

Gender
All
Age
18 - 80 years
Injury level
C1 - C8
  • Severity (AIS)?
  • AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C1-C8

    What’s involved

    Type

    Technology

    Details

    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 results of injuries or diseases such as SCI and promoting 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.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Spasticity

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Oct 2023
    • Organisation
    • Kessler Foundation
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 15 Oct 2023
    • Organisation
    • Kessler Foundation

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more