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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

Kessler Foundation logo

Kessler Foundation

Status and phase

Enrolling
Early Phase 1

Conditions

SCI - Spinal Cord Injury

Treatments

Device: MyoPro robot only
Other: Games only
Combination Product: MyoMo orthosis and VR games
Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT05386537
D-1113-20

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

20 participants in 4 patient groups

MyoPro-VR/HM group
Experimental group
Description:
Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis combined with VR-video games and Haptics.
Treatment:
Other: Games only
Combination Product: MyoMo orthosis and VR games
Device: MyoPro robot only
MyoPro group
Active Comparator group
Description:
Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis only.
Treatment:
Device: MyoPro robot only
VR/HM group
Active Comparator group
Description:
Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using VR-video games only.
Treatment:
Other: Games only
control
Other group
Description:
Receive 18 sessions (in 6 weeks) of conventional UE therapy at a rehabilitation facility.
Treatment:
Other: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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