Recruiting

Powered Orthotics

Sponsor:

Kessler Foundation

Code:

NCT06349434

Conditions

SCI - Spinal Cord Injury

Upper Extremity Dysfunction

Upper Extremity Problem

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MyoMo

conventional therapy

Study Details

Brief 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.

Conditions

SCI - Spinal Cord Injury

Upper Extremity Dysfunction

Upper Extremity Problem

Study ID

NCT06349434

Start date

Oct 15, 2023

Status verified date

Nov, 2025

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be between ages 18-80
  • Be able to activate certain muscles in my arm and forearm on my own a sufficient amount as measured by EMG amplitude. This will be determined by the study OT/PT.
  • Be diagnosed with spinal cord injury (SCI) with level C1-C8 and ASIA Impairment Scale (AIS) C or D, as determined by study staff. If I have not had an exam to determine my injury level and impairment scale recently, I may participate in an examination of my sensation and strength in my arms, legs, trunk and rectum as was done in the hospital soon after my injury.
  • Be at least 1-year post injury
  • Have sufficient ability to move my shoulder (active shoulder flexion of 30 degrees and active shoulder abduction 20 degrees), as determined by study staff
  • Be medically stable
  • Have sufficient learning and memory abilities and abilities to communicate in English to be able to participate and follow directions during my rehabilitation
  • Continue to take all prescribed medication (e.g., oral or via pump baclofen) without any dosing changes
  • Be able to tolerate functional tasks for 60 minutes with periodic rests without excessive fatigue
  • Have minimal strength in the muscles that bend and straighten my elbow, as determined by study staff
  • Have full range of motion in my elbow when it is moved by the study therapist

Exclusion Criteria:

  • Be younger than 18 years old or older than 80
  • Have excessive pain in my arm, wrist, or hand that limits providing rehabilitation
  • Have excessive spasticity in my elbow or wrist, as determined by study staff
  • Be participating in any experimental rehabilitation or drug studies
  • Have history of nervous system disorder other than SCI
  • Have difficulty following multiple step directions
  • Have severe cognitive or psychiatric problems might be contraindications to start training.
  • Have skin issues or severe sensory deficits that would prevent wearing the Myo-Pro device safely
  • Be pregnant
  • Have other conditions or circumstances that, in the opinion of the investigators, would affect the safety or effectiveness of the training in which I would participate

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MyoPro

Receiving MyoMo training in-clinic for 6 weeks, and continuing MyoMo training in-clinic and at home for another 6 weeks.

active comparator: Control

Receiving conventional therapy in-clinic and using their prescribed static brace (or others) for 6 weeks, and continuing the conventional therapy in-clinic and home using their prescribed static brace (or others) at home for 6 weeks.

Interventions

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).

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.

Primary outcome measure

  • GRASSP [ Time Frame: Approximately 36 weeks ]
  • Range of motion of hands and arms [ Time Frame: Approximately 36 weeks ]
  • Muscle strength measurement [ Time Frame: Approximately 36 weeks ]

Central Contacts and Locations

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Ghaith J Androwis, Ph.D.

201-968-6110gandrowis@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2025-11-24.