RECRUITING

Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons With Acute SCI

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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

This randomized clinical trial (RCT) is evaluating the usefulness of combining MyoMo robotic orthosis with visual and haptic feedback in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with acute SCI.

Official Title

Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons With Acute SCI

Quick Facts

Study Start:2021-04-01

Study Completion:2024-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05386537

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 the ages of 18-80 * Be able to activate the muscles of my upper arm and forearm with enough strength as determined by the therapist. * Be diagnosed with a spinal cord injury (iSCI (ASIA Impairment Scale (AIS) C and D) and be less than 3 months post initial injury at the start of the study * Be medically stable * Be able to follow study directions and communicate in English as determined by the study staff * Continue to take all prescribed medication (example: baclofen: oral or via pump) without any major dosing changes * Be able to tolerate functional tasks for 60min with intermittent rests without excessive fatigue * Have full passive range of motion at my elbow, as determined by study staff	* Be younger than 18 years old or older than 80 * Have excessive pain in my arm or hand that would limit my participation in rehabilitation * Have excessive spasticity in my elbow or wrist joints as determined by study staff * Be participating in any experimental rehabilitation or drug studies * Have a history of neurologic disorder other than spinal cord injury * Have other conditions that would prevent safe and/or effective participation using the study device. Examples of these conditions include: severe sensory deficits, skin conditions, joint contractures, etc. * Have difficulty following multiple step directions * Have severe psychiatric problems or difficulty thinking clearly that would prevent me from participating in this study * Have skin issues that would prevent wearing the Myo-Pro device * Have had history of recurrent epilepsy, seizure or convulsion * Have a past or current history of treated ringing in the ears known as tinnitus or severe hearing problems. * Be taking any drugs that would increase my risk of having a seizure while undergoing brain stimulation. Study staff and physician will review my medications to see if I am taking any of these drugs. If I am taking one of these drugs, I will not be enrolled in this study. * Because of potential risk to the fetus, women of child-bearing potential will be required to have a pregnancy test before they can enroll in this study. If I am female, and have a positive pregnancy test, I will not be enrolled.

Inclusion Criteria

Exclusion Criteria

* Be between the ages of 18-80
* Be able to activate the muscles of my upper arm and forearm with enough strength as determined by the therapist.
* Be diagnosed with a spinal cord injury (iSCI (ASIA Impairment Scale (AIS) C and D) and be less than 3 months post initial injury at the start of the study
* Be medically stable
* Be able to follow study directions and communicate in English as determined by the study staff
* Continue to take all prescribed medication (example: baclofen: oral or via pump) without any major dosing changes
* Be able to tolerate functional tasks for 60min with intermittent rests without excessive fatigue
* Have full passive range of motion at my elbow, as determined by study staff

* Be younger than 18 years old or older than 80
* Have excessive pain in my arm or hand that would limit my participation in rehabilitation
* Have excessive spasticity in my elbow or wrist joints as determined by study staff
* Be participating in any experimental rehabilitation or drug studies
* Have a history of neurologic disorder other than spinal cord injury
* Have other conditions that would prevent safe and/or effective participation using the study device. Examples of these conditions include: severe sensory deficits, skin conditions, joint contractures, etc.
* Have difficulty following multiple step directions
* Have severe psychiatric problems or difficulty thinking clearly that would prevent me from participating in this study
* Have skin issues that would prevent wearing the Myo-Pro device
* Have had history of recurrent epilepsy, seizure or convulsion
* Have a past or current history of treated ringing in the ears known as tinnitus or severe hearing problems.
* Be taking any drugs that would increase my risk of having a seizure while undergoing brain stimulation. Study staff and physician will review my medications to see if I am taking any of these drugs. If I am taking one of these drugs, I will not be enrolled in this study.
* Because of potential risk to the fetus, women of child-bearing potential will be required to have a pregnancy test before they can enroll in this study. If I am female, and have a positive pregnancy test, I will not be enrolled.

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 Date2021-04-01

Study Completion Date2024-10-01

Study Record Updates

Study Start Date2021-04-01

Study Completion Date2024-10-01

Terms related to this study

Additional Relevant MeSH Terms

SCI - Spinal Cord Injury