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

NCT05386537 | Unknown Early Phase 1 FDA Drug FDA Device

• 1 other identifier: D-1113-20
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Range of motion of hands and arms

  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.

  Approximately 10 weeks

• Muscle strength measurement

  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.

  Approximately 10 weeks

• GRASSP

  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.

  Approximately 10 weeks

Secondary Outcomes (1)

• Brain signals measurement

  Approximately 10 weeks

Study Arms (4)

MyoPro-VR/HM group

EXPERIMENTAL

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; Device: MyoPro robot only; Other: Games only

MyoPro group

ACTIVE COMPARATOR

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

Device: MyoPro robot only

VR/HM group

ACTIVE COMPARATOR

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

Other: Games only

control

OTHER

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

Other: Control

Interventions

MyoMo orthosis and VR games 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

Also known as: Control

MyoPro-VR/HM group

MyoPro robot only DEVICE

Using the MyoPro wearable robotic orthosis only

MyoPro group; MyoPro-VR/HM group

Games only OTHER

Using VR-video games only

MyoPro-VR/HM group; VR/HM group

Control OTHER

conventional UE therapy at a rehabilitation facility

control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: April 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

US (1)