The Efficacy of Upper Extremity Wearable Robotic Orthosis on Improving Upper Extremity Motor Function and Activities of Daily Living in Persons With Spinal Cord Injury

Completed · Not applicable

Conditions studied: SCI - Spinal Cord Injury

In brief

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)

Key facts

Study ID

NCT04855812

Run by

Kessler Foundation

People needed

15

Starts

2019-10-27

Expected to finish

2023-09-30

Last updated by the study team

2024-04-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be between ages 18-80.
• Be able to activate biceps \& triceps brachii, and forearm muscles with sufficient muscle signal amplitude as determined by the physical/ occupational therapist.
• Be diagnosed with SCI (iSCI (ASIA Impairment Scale (AIS) C and D, (C1-C8)) and be at least 1-year post injury.
• Be medically stable.
• Be able to follow directions for the tasks of the study and to communicate in English with the study staff.
• Continue to take all prescribed medication (e.g. oral or via pump baclofen) without any dosing changes.
• Be able to tolerate functional tasks for 60min with intermittent rests without excessive fatigue.
• Have some visible muscle contraction (with or without range of motion) on their upper extremity as determined by study staff.
• Have full passive range of motion for elbow flexion and extension as determined by study staff.

You may not qualify if…

• Have excessive pain in the upper extremity that limits my receiving rehabilitation therapy.
• Have excessive spasticity: Patients with modified ashworth scale (MAS) of 2 and higher at the wrist or 3 at the elbow joints as determined by study staff.
• Be participating in any experimental rehabilitation or drug studies.
• Have history of neurologic disorder other than SCI.
• Have other conditions or circumstances that, in the opinion of the investigators, would preclude safe and/or effective participation, including severe sensory deficits, skin conditions, and/or other conditions that may be contradicted for myoelectric Myo-Pro use.
• Have difficulty following multiple step directions.
• Have severe problems with thinking and understanding or psychiatric problems that might limit my ability to do training.
• 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.
• Study staff and physician will review my medications to determine if I am taking any drugs that would increase my risk of having a seizure while undergoing brain stimulation. If I am taking such a medication 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.

Where it is running

• Kessler Foundation — West Orange, New Jersey, United States

Full record on ClinicalTrials.gov

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