The Efficacy of Upper Extremity Wearable Robotic Orthosis... | NCT04855812

Status Module

Name	Class
United States Department of Defense	FED

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MyoPro	Experimental	Receiving MyoMo training in-clinic and at home for 6-weeks	Device: MyoMo
Myo-SB	Active Comparator	Receiving MyoMo training in-clinic and using their prescribed static brace (or others) at home for 6-weeks	Other: Myo-SB
Control	Active Comparator	Receiving conventional therapy/training in-clinic and using their prescribed static brace (or others) at home for 6-weeks	Other: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MyoMo	Device	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).

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
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
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
Spasticity measurement	Spasticity measurements of upper and lower extremities using the Modified Ashworth scale (MAS). The MAS scores range between 0 to 4. A higher score signifies larger level of spasticity and a lower score indicates smaller level of spasticity. scores are as follows: 0: No increase in muscle tone Slight increase in muscle tone 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion More marked increase in muscle tone through most of the range of motion. Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension

Eligibility Module

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.

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