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The Efficacy of Upper Extremity Wearable Robotic Orthosis on Improving Upper Extremity Motor Function and Activities of Daily Living in Persons With Spinal Cord Injury (MyoMo in SCI)

Primary Purpose

SCI - Spinal Cord Injury

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MyoMo
Myo-SB
Control
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other 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 ages 18-80.
  • Be able to activate biceps & triceps brachii, and forearm muscles with sufficient muscle signal amplitude as determined by the physical/ occupational therapist.
  • Be diagnosed with SCI (iSCI (ASIA Impairment Scale (AIS) C and D, (C1-C8)) and be at least 1-year post injury.
  • Be medically stable.
  • Be able to follow directions for the tasks of the study and to communicate in English with the study staff.
  • Continue to take all prescribed medication (e.g. oral or via pump baclofen) without any dosing changes.
  • Be able to tolerate functional tasks for 60min with intermittent rests without excessive fatigue.
  • Have some visible muscle contraction (with or without range of motion) on their upper extremity as determined by study staff.
  • Have full passive range of motion for elbow flexion and extension as determined by study staff.

Exclusion Criteria:

  • Have excessive pain in the upper extremity that limits my receiving rehabilitation therapy.
  • Have excessive spasticity: Patients with modified ashworth scale (MAS) of 2 and higher at the wrist or 3 at the elbow joints as determined by study staff.
  • Be participating in any experimental rehabilitation or drug studies.
  • Have history of neurologic disorder other than SCI.
  • Have other conditions or circumstances that, in the opinion of the investigators, would preclude safe and/or effective participation, including severe sensory deficits, skin conditions, and/or other conditions that may be contradicted for myoelectric Myo-Pro use.
  • Have difficulty following multiple step directions.
  • Have severe problems with thinking and understanding or psychiatric problems that might limit my ability to do training.
  • 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.
  • Study staff and physician will review my medications to determine if I am taking any drugs that would increase my risk of having a seizure while undergoing brain stimulation. If I am taking such a medication 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 Type

Experimental

Active Comparator

Active Comparator

Arm Label

MyoPro

Myo-SB

Control

Arm Description

Receiving MyoMo training in-clinic and at home for 6-weeks

Receiving MyoMo training in-clinic and using their prescribed static brace (or others) at home for 6-weeks

Receiving conventional therapy/training in-clinic and using their prescribed static brace (or others) at home for 6-weeks

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.
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.
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.
Spasticity measurement
Spasticity measurements of upper and lower extremities using the Modified Ashworth scale (MAS). The MAS scores range between 0 to 4. A higher score signifies larger level of spasticity and a lower score indicates smaller level of spasticity. scores are as follows: 0: No increase in muscle tone Slight increase in muscle tone 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion More marked increase in muscle tone through most of the range of motion. Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension
CUE-Q
The Capabilities of Upper Extremity Test (a list of questionnaire based evaluation). Scores range between 0 to 4, and higher scores indicates better ability outcome for reaching or lifting the upper limb.

Secondary Outcome Measures

Full Information

First Posted
February 3, 2020
Last Updated
May 3, 2023
Sponsor
Kessler Foundation
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT04855812
Brief Title
The Efficacy of Upper Extremity Wearable Robotic Orthosis on Improving Upper Extremity Motor Function and Activities of Daily Living in Persons With Spinal Cord Injury
Acronym
MyoMo in SCI
Official Title
The Efficacy of Upper Extremity Wearable Robotic Orthosis on Improving Upper Extremity Motor Function and Activities of Daily Living in Persons With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the usefulness of an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI)
Detailed Description
The study will take me approximately 10 weeks from the time of consent. This includes initial screening visit, a baseline assessment, and a follow-up visit (after 6 weeks of therapy). The baseline and follow up visit will include 2 separate testing sessions, each session will last approximately 2 hours. I will also participate in approximately 3 training sessions per week for 6 weeks. Each training session will last approximately 60 minutes.

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
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized Clinical Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MyoPro
Arm Type
Experimental
Arm Description
Receiving MyoMo training in-clinic and at home for 6-weeks
Arm Title
Myo-SB
Arm Type
Active Comparator
Arm Description
Receiving MyoMo training in-clinic and using their prescribed static brace (or others) at home for 6-weeks
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Receiving conventional therapy/training in-clinic and using their prescribed static brace (or others) at home for 6-weeks
Intervention Type
Device
Intervention Name(s)
MyoMo
Intervention Description
To evaluate the usefulness of an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI).
Intervention Type
Other
Intervention Name(s)
Myo-SB
Intervention Description
To evaluate the usefulness of an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
To evaluate the usefulness of an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI).
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
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
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
Title
Spasticity measurement
Description
Spasticity measurements of upper and lower extremities using the Modified Ashworth scale (MAS). The MAS scores range between 0 to 4. A higher score signifies larger level of spasticity and a lower score indicates smaller level of spasticity. scores are as follows: 0: No increase in muscle tone Slight increase in muscle tone 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion More marked increase in muscle tone through most of the range of motion. Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension
Time Frame
Approximately 10 weeks
Title
CUE-Q
Description
The Capabilities of Upper Extremity Test (a list of questionnaire based evaluation). Scores range between 0 to 4, and higher scores indicates better ability outcome for reaching or lifting the upper limb.
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 ages 18-80. Be able to activate biceps & triceps brachii, and forearm muscles with sufficient muscle signal amplitude as determined by the physical/ occupational therapist. Be diagnosed with SCI (iSCI (ASIA Impairment Scale (AIS) C and D, (C1-C8)) and be at least 1-year post injury. Be medically stable. Be able to follow directions for the tasks of the study and to communicate in English with the study staff. Continue to take all prescribed medication (e.g. oral or via pump baclofen) without any dosing changes. Be able to tolerate functional tasks for 60min with intermittent rests without excessive fatigue. Have some visible muscle contraction (with or without range of motion) on their upper extremity as determined by study staff. Have full passive range of motion for elbow flexion and extension as determined by study staff. Exclusion Criteria: Have excessive pain in the upper extremity that limits my receiving rehabilitation therapy. Have excessive spasticity: Patients with modified ashworth scale (MAS) of 2 and higher at the wrist or 3 at the elbow joints as determined by study staff. Be participating in any experimental rehabilitation or drug studies. Have history of neurologic disorder other than SCI. Have other conditions or circumstances that, in the opinion of the investigators, would preclude safe and/or effective participation, including severe sensory deficits, skin conditions, and/or other conditions that may be contradicted for myoelectric Myo-Pro use. Have difficulty following multiple step directions. Have severe problems with thinking and understanding or psychiatric problems that might limit my ability to do training. 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. Study staff and physician will review my medications to determine if I am taking any drugs that would increase my risk of having a seizure while undergoing brain stimulation. If I am taking such a medication 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

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The Efficacy of Upper Extremity Wearable Robotic Orthosis on Improving Upper Extremity Motor Function and Activities of Daily Living in Persons With Spinal Cord Injury

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