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

NCT06349434 | Recruiting DMC FDA Device

• 1 other identifier: R-1215-23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• GRASSP

  Assessment of the Hand in Tetraplegia Using the Graded Redefined Assessment of Strength Sensibility and Prehension Upper Extremity (UE) Function in Persons with Tetraplegia Relationships Between Strength, Capacity and the Spinal Cord Independence Measure. Total score's minimum and maximum values are between 0 to 116 and higher scores indicate better/improved outcomes.

  Approximately 36 weeks

• Range of motion of hands and arms

  Movement of upper extremity is measured using small sensors that are able to record joints' angles. These sensors are placed on participant's skin via double sticky tape. Participants will be asked to move their hand and forearm while the elbow, wrist and hand joint angles are measured.

  Approximately 36 weeks

• Muscle strength measurement

  during movements of upper extremities muscle strength is measured using small and light weight surface electromyography sensors which are placed on the participant's skin via double stick tape. Participants will be asked to move their hand and forearm while the muscle strength is measured.

  Approximately 36 weeks

Secondary Outcomes (3)

• Spasticity measurement

  Approximately 36 weeks

• Brain signals measurement

  Approximately 36 weeks

• CUE-Q

  Approximately 36 weeks

Study Arms (2)

MyoPro

EXPERIMENTAL

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

Device: MyoMo

Control

ACTIVE COMPARATOR

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.

Other: conventional therapy

Interventions

MyoMo DEVICE

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).

MyoPro

conventional therapy OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: April 1, 2024
• First Posted: April 5, 2024
• Study Start: October 15, 2023
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)