Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons With Acute SCI

Sponsor
Kessler Foundation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05386537
Collaborator
(none)
20
1
4
30
0.7

Study Details

Study Description

Brief Summary

This randomized clinical trial (RCT) is evaluating the usefulness of combining MyoMo robotic orthosis with visual and haptic feedback in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with acute SCI.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: MyoMo orthosis and VR games
  • Device: MyoPro robot only
  • Other: Games only
  • Other: Control
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons With Acute SCI
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MyoPro-VR/HM group

Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis combined with VR-video games and Haptics.

Combination Product: MyoMo orthosis and VR games
Combining Wearable Robotic Orthosis with Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons with Acute SCI
Other Names:
  • Control
  • Device: MyoPro robot only
    Using the MyoPro wearable robotic orthosis only

    Other: Games only
    Using VR-video games only

    Active Comparator: MyoPro group

    Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis only.

    Device: MyoPro robot only
    Using the MyoPro wearable robotic orthosis only

    Active Comparator: VR/HM group

    Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using VR-video games only.

    Other: Games only
    Using VR-video games only

    Other: control

    Receive 18 sessions (in 6 weeks) of conventional UE therapy at a rehabilitation facility.

    Other: Control
    conventional UE therapy at a rehabilitation facility

    Outcome Measures

    Primary Outcome Measures

    1. Range of motion of hands and arms [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 [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. GRASSP [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.

    Secondary Outcome Measures

    1. Brain signals measurement [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Be between the ages of 18-80

    • Be able to activate the muscles of my upper arm and forearm with enough strength as determined by the therapist.

    • Be diagnosed with a spinal cord injury (iSCI (ASIA Impairment Scale (AIS) C and D) and be less than 3 months post initial injury at the start of the study

    • Be medically stable

    • Be able to follow study directions and communicate in English as determined by the study staff

    • Continue to take all prescribed medication (example: baclofen: oral or via pump) without any major dosing changes

    • Be able to tolerate functional tasks for 60min with intermittent rests without excessive fatigue

    • Have full passive range of motion at my elbow, as determined by study staff

    Exclusion Criteria:
    • Be younger than 18 years old or older than 80

    • Have excessive pain in my arm or hand that would limit my participation in rehabilitation

    • Have excessive spasticity in my elbow or wrist joints as determined by study staff

    • Be participating in any experimental rehabilitation or drug studies

    • Have a history of neurologic disorder other than spinal cord injury

    • Have other conditions that would prevent safe and/or effective participation using the study device. Examples of these conditions include: severe sensory deficits, skin conditions, joint contractures, etc.

    • Have difficulty following multiple step directions

    • Have severe psychiatric problems or difficulty thinking clearly that would prevent me from participating in this study

    • 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.

    • Be taking any drugs that would increase my risk of having a seizure while undergoing brain stimulation. Study staff and physician will review my medications to see if I am taking any of these drugs. If I am taking one of these drugs, 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

    Locations

    Site City State Country Postal Code
    1 Kessler Foundation West Orange New Jersey United States 07052

    Sponsors and Collaborators

    • Kessler Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kessler Foundation
    ClinicalTrials.gov Identifier:
    NCT05386537
    Other Study ID Numbers:
    • D-1113-20
    First Posted:
    May 23, 2022
    Last Update Posted:
    May 27, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 27, 2022