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

Early Phase 1

Recruiting

• Conditions: SCI - Spinal Cord Injury
• Interventions: Device: MyoPro robot only; Other: Control; Combination Product: MyoMo orthosis and VR games; Other: Games only

• Registration Number: NCT05386537
• Lead Sponsor: Kessler Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-18
• Study First Posted: 2022-05-23
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-03
• Last Update Posted: 2023-05-06
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
MyoPro group	MyoPro robot only	Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis only.
MyoPro-VR/HM group	MyoPro robot only	Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis combined with VR-video games and Haptics.
control	Control	Receive 18 sessions (in 6 weeks) of conventional UE therapy at a rehabilitation facility.
MyoPro-VR/HM group	MyoMo orthosis and VR games	Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis combined with VR-video games and Haptics.
MyoPro-VR/HM group	Games only	Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis combined with VR-video games and Haptics.
VR/HM group	Games only	Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using VR-video games only.

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States