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

NCT ID: NCT04855812

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-27
• Study Completion Date: 2023-09-30

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.

Conditions

SCI - Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

MyoPro

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

Group Type: EXPERIMENTAL

MyoMo

Intervention Type: 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).

Myo-SB

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

Group Type: ACTIVE_COMPARATOR

Myo-SB

Intervention Type: OTHER

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).

Control

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

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

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).

Interventions

MyoMo

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).

Intervention Type: DEVICE

Myo-SB

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).

Intervention Type: OTHER

Control

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kessler Foundation

West Orange, New Jersey, United States

Countries

United States

Other Identifiers

D-1028-18

Identifier Type: -

Identifier Source: org_study_id