SCI - Spinal Cord InjuryEarly Phase 1NCT05386537
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
A Early Phase 1 study testing MyoMo orthosis and VR games, MyoPro robot only and Games only in people with SCI - Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- MyoMo orthosis and VR games, MyoPro robot only and Games only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Oct 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Ghaith J Androwis, Ph.D., 973-324-3565, gandrowis@kesslerfoundation.org
About this study
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
- Being tested
- MyoMo orthosis and VR games, MyoPro robot only, Games only, Control
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoMo orthosis and VR gamesCombination product
Also called Control
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 onlyDevice
Using the MyoPro wearable robotic orthosis only
Games onlyOther
Using VR-video games only
ControlOther
conventional UE therapy at a rehabilitation facility
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Games only |
| control | Other | Receive 18 sessions (in 6 weeks) of conventional UE therapy at a rehabilitation facility. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
Measured: Approximately 10 weeks
Secondary outcomes (1)
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.
Measured: Approximately 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Apr 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386537
- Sponsor's protocol ID
- D-1113-20
- Status last verified
- May 2023
- First submitted
- 18 May 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05386537
- Acronym / sponsor ID
- D-1113-20
- Conditions
- SCI - Spinal Cord Injury
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MyoPro-VR/HM group | Experimental | Combination Product: MyoMo orthosis and VR games, Device: MyoPro robot only, Other: Games onlyReceive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis combined with VR-video games and Haptics. |
| MyoPro group | Active comparator | Device: MyoPro robot onlyReceive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using the MyoPro wearable robotic orthosis only. |
| VR/HM group | Active comparator | Other: Games onlyReceive 18 sessions (in 6 weeks) of wrist/hand/UE rehabilitation using VR-video games only. |
| control | Other | Other: ControlReceive 18 sessions (in 6 weeks) of conventional UE therapy at a rehabilitation facility. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyoMo orthosis and VR gamesAlso: ControlCombining Wearable Robotic Orthosis with Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons with Acute SCI | Combination product | MyoPro-VR/HM group |
| MyoPro robot onlyUsing the MyoPro wearable robotic orthosis only | Device | MyoPro group, MyoPro-VR/HM group |
| Games onlyUsing VR-video games only | Other | MyoPro-VR/HM group, VR/HM group |
| Controlconventional UE therapy at a rehabilitation facility | Other | control |
Primary outcome
Range of motion of hands and arms
Time frame: Approximately 10 weeks
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
Time frame: Approximately 10 weeks
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
Time frame: Approximately 10 weeks
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.
1 secondary outcome
Brain signals measurement
Time frame: Approximately 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MyoMo orthosis and VR games, MyoPro robot only and Games only in people with SCI - Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion of hands and arms (time frame: Approximately 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.