Combining Wearable Robotic Orthosis With Visual and Hapti... | NCT05386537

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MyoPro-VR/HM group	Experimental	Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis combined with VR-video games and Haptics.	Combination Product: MyoMo orthosis and VR games Device: MyoPro robot only Other: Games only
MyoPro group	Active Comparator	Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis only.	Device: MyoPro robot only
VR/HM group	Active Comparator	Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using VR-video games only.	Other: Games only
control	Other	Receive 18 sessions (in 6 weeks) of conventional UE therapy at a rehabilitation facility.	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MyoMo orthosis and VR games	Combination Product	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Range of motion of hands and arms	Movement of upper extremity is measured using small sensors that are able to record joints' angles. These sensors are placed on participant's skin via double sticky tape. Participants will be asked to move their hand and forearm while the elbow, wrist and hand joint angles are measured.	Approximately 10 weeks
Muscle strength measurement	during movements of upper extremities muscle strength is measured using small and light weight surface electromyography sensors which are placed on the participant's skin via double stick tape. Participants will be asked to move their hand and forearm while the muscle strength is measured.	Approximately 10 weeks
GRASSP	Assessment of the Hand in Tetraplegia Using the Graded Redefined Assessment of Strength Sensibility and Prehension Upper Extremity Function in Persons with Tetraplegia Relationships Between Strength, Capacity and the Spinal Cord Independence Measure. Total score's minimum and maximum values are between 0 to 116 and higher scores indicate better/improved outcomes.	Approximately 10 weeks

Secondary Outcomes

Measure	Description	Time Frame
Brain signals measurement	Measurements of brain signals is done using a cap and electrodes that would be placed on the participant's head using surface electrodes. Participants will be asked to move their extremities while brain signals are measured.	Approximately 10 weeks

Eligibility Module

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.

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System
D014947	Wounds and Injuries