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 (MyoMo in SCI)
Status
Conditions
Treatments
Details and patient eligibility
About
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)
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
15 participants in 3 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal