Clinical trial NCT05386537: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: SCI - Spinal Cord Injury
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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.

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