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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

Primary Purpose

SCI - Spinal Cord Injury

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
MyoMo orthosis and VR games
MyoPro robot only
Games only
Control
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for SCI - Spinal Cord Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Other

Arm Label

MyoPro-VR/HM group

MyoPro group

VR/HM group

control

Arm 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.

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Brain signals measurement
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.

Full Information

First Posted
May 18, 2022
Last Updated
May 3, 2023
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05386537
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SCI - Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MyoPro-VR/HM group
Arm Type
Experimental
Arm 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.
Arm Title
MyoPro group
Arm Type
Active Comparator
Arm Description
Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis only.
Arm Title
VR/HM group
Arm Type
Active Comparator
Arm Description
Receive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using VR-video games only.
Arm Title
control
Arm Type
Other
Arm Description
Receive 18 sessions (in 6 weeks) of conventional UE therapy at a rehabilitation facility.
Intervention Type
Combination Product
Intervention Name(s)
MyoMo orthosis and VR games
Other Intervention Name(s)
Control
Intervention Description
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
Device
Intervention Name(s)
MyoPro robot only
Intervention Description
Using the MyoPro wearable robotic orthosis only
Intervention Type
Other
Intervention Name(s)
Games only
Intervention Description
Using VR-video games only
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
conventional UE therapy at a rehabilitation facility
Primary Outcome Measure Information:
Title
Range of motion of hands and arms
Description
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.
Time Frame
Approximately 10 weeks
Title
Muscle strength measurement
Description
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.
Time Frame
Approximately 10 weeks
Title
GRASSP
Description
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.
Time Frame
Approximately 10 weeks
Secondary Outcome Measure Information:
Title
Brain signals measurement
Description
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.
Time Frame
Approximately 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghaith J Androwis, Ph.D.
Phone
973-324-3565
Email
gandrowis@kesslerfoundation.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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