RECRUITING

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

Conditions

SCI - Spinal Cord Injury Upper Extremity Dysfunction Upper Extremity Problem

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-15

Study Completion:2028-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06349434

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Kessler Foundation

West Orange, New Jersey, 07052

United States

Collaborators and Investigators

Sponsor: Kessler Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-15

Study Completion Date2028-10-01

Study Record Updates

Study Start Date2023-10-15

Study Completion Date2028-10-01

Terms related to this study

Additional Relevant MeSH Terms

SCI - Spinal Cord Injury
Upper Extremity Dysfunction
Upper Extremity Problem