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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 (MyoMo in SCI)

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ClinicalTrials.gov Identifier: NCT04855812
Recruitment Status : Recruiting
First Posted : April 22, 2021
Last Update Posted : May 24, 2022
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Kessler Foundation

Study Description
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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)

Condition or disease Intervention/treatment Phase
SCI - Spinal Cord Injury Device: MyoMo Other: Myo-SB Other: Control Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized Clinical Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : October 27, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: MyoPro
Receiving MyoMo training in-clinic and at home for 6-weeks
 Device: 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).
Active Comparator: Myo-SB
Receiving MyoMo training in-clinic and using their prescribed static brace (or others) at home for 6-weeks
 Other: 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).
Active Comparator: Control
Receiving conventional therapy/training in-clinic and using their prescribed static brace (or others) at home for 6-weeks
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Range of motion of hands and arms [ Time Frame: Approximately 10 weeks ]

    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.


  2. Muscle strength measurement [ Time Frame: Approximately 10 weeks ]

    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.


  3. Brain signals measurement [ Time Frame: Approximately 10 weeks ]

    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.


  4. GRASSP [ Time Frame: Approximately 10 weeks ]

    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.


  5. Spasticity measurement [ Time Frame: Approximately 10 weeks ]

    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

  6. CUE-Q [ Time Frame: Approximately 10 weeks ]

    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.



Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855812


Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Ghaith J Androwis, Ph.D.    973-324-3565    gandrowis@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
United States Department of Defense
More Information
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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT04855812    
Other Study ID Numbers: D-1028-18
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System