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

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

Sponsors

Lead Sponsor: Kessler Foundation

Collaborator: United States Department of Defense

Source Kessler Foundation
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.

Overall Status Recruiting
Start Date 2019-10-27
Completion Date 2021-09-30
Primary Completion Date 2021-09-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Range of motion of hands and arms Approximately 10 weeks
Muscle strength measurement Approximately 10 weeks
Brain signals measurement Approximately 10 weeks
GRASSP Approximately 10 weeks
Spasticity measurement Approximately 10 weeks
CUE-Q Approximately 10 weeks
Enrollment 24
Condition
Intervention

Intervention Type: Device

Intervention Name: MyoMo

Description: 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).

Arm Group Label: MyoPro

Intervention Type: Other

Intervention Name: Myo-SB

Description: 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).

Arm Group Label: Myo-SB

Intervention Type: Other

Intervention Name: Control

Description: 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).

Arm Group Label: Control

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Location
Facility: Status: Contact: Kessler Foundation Ghaith J Androwis, Ph.D. 973-324-3565 [email protected]
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: MyoPro

Type: Experimental

Description: Receiving MyoMo training in-clinic and at home for 6-weeks

Label: Myo-SB

Type: Active Comparator

Description: Receiving MyoMo training in-clinic and using their prescribed static brace (or others) at home for 6-weeks

Label: Control

Type: Active Comparator

Description: Receiving conventional therapy/training in-clinic and using their prescribed static brace (or others) at home for 6-weeks

Acronym MyoMo in SCI
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Randomized Clinical Trial

Primary Purpose: Other

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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