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

NCT ID: NCT05386537

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-10-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

MyoMo orthosis and VR games

Intervention Type: COMBINATION_PRODUCT

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

Intervention Type: DEVICE

Using the MyoPro wearable robotic orthosis only

Games only

Intervention Type: OTHER

Using VR-video games only

MyoPro group

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

Group Type: ACTIVE_COMPARATOR

MyoPro robot only

Intervention Type: DEVICE

Using the MyoPro wearable robotic orthosis only

VR/HM group

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

Group Type: ACTIVE_COMPARATOR

Games only

Intervention Type: OTHER

Using VR-video games only

control

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

Group Type: OTHER

Control

Intervention Type: OTHER

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

Intervention Type: COMBINATION_PRODUCT

MyoPro robot only

Using the MyoPro wearable robotic orthosis only

Intervention Type: DEVICE

Games only

Using VR-video games only

Intervention Type: OTHER

Control

conventional UE therapy at a rehabilitation facility

Intervention Type: OTHER

Other Intervention Names

Control

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kessler Foundation

West Orange, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Ghaith J Androwis, Ph.D.

Role: primary

gandrowis@kesslerfoundation.org

973-324-3565

Other Identifiers

D-1113-20

Identifier Type: -

Identifier Source: org_study_id