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

SCI - Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05386537
• Other study ID #: D-1113-20
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2023
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• SCI - Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Combination Product:
• 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

Device:
• MyoPro robot only
Using the MyoPro wearable robotic orthosis only

Other:
• Games only
Using VR-video games only
• Control
conventional UE therapy at a rehabilitation facility

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Approximately 10 weeks