Recruiting
Early Phase 1

Wearable Robotic Orthosis

Sponsor:

Kessler Foundation

Code:

NCT05386537

Conditions

SCI - Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

MyoMo orthosis and VR games

MyoPro robot only

Games only

Control

Study Details

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.

Conditions

SCI - Spinal Cord Injury

Study ID

NCT05386537

Start date

Apr 1, 2021

Status verified date

May, 2023

Completion date

Oct 1, 2024

Anticipated

Primary completion date

Oct 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: MyoPro group

Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation 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: control

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

Interventions

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

MyoPro robot only

Using the MyoPro wearable robotic orthosis only

Games only

Using VR-video games only

Control

conventional UE therapy at a rehabilitation facility

Primary outcome measure

  • Range of motion of hands and arms [ Time Frame: Approximately 10 weeks ]
  • Muscle strength measurement [ Time Frame: Approximately 10 weeks ]
  • GRASSP [ Time Frame: Approximately 10 weeks ]

Central Contacts and Locations

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Ghaith J Androwis, Ph.D.

973-324-3565gandrowis@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

May 6, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2023-05-06.