Clinical trial NCT04855812: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SCI - Spinal Cord Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2021-04-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized Clinical Trial
Primary purpose: OTHER

Brief summary: 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)

Detailed description: The study will take me approximately 10 weeks from the time of consent. This includes initial screening visit, a baseline assessment, and a follow-up visit (after 6 weeks of therapy). The baseline and follow up visit will include 2 separate testing sessions, each session will last approximately 2 hours. I will also participate in approximately 3 training sessions per week for 6 weeks. Each training session will last approximately 60 minutes.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Range of motion of hands and arms
timeFrame: Approximately 10 weeks
measure: Muscle strength measurement
timeFrame: Approximately 10 weeks
measure: Brain signals measurement
timeFrame: Approximately 10 weeks
measure: GRASSP
timeFrame: Approximately 10 weeks
measure: Spasticity measurement
timeFrame: Approximately 10 weeks
measure: CUE-Q
timeFrame: Approximately 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: