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

NCT04855812 | Completed DMC FDA Device

• 1 other identifier: D-1028-18
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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)

Conditions

SCI - Spinal Cord Injury

Outcome Measures

Primary Outcomes (6)

• 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 1. 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 2. More marked increase in muscle tone through most of the range of motion. 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension

  Approximately 10 weeks

• CUE-Q

  The Capabilities of Upper Extremity Test (a list of questionnaire based evaluation). Scores range between 0 to 4, and higher scores indicates better ability outcome for reaching or lifting the upper limb.

  Approximately 10 weeks

Study Arms (3)

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

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).

MyoPro

Myo-SB 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).

Myo-SB

Control 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• United States Department of Defense: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: April 22, 2021
• Study Start: October 27, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

US (1)