SCI - Spinal Cord InjuryNCT06349434
The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI
A study testing MyoMo and conventional therapy in people with SCI - Spinal Cord Injury and Upper Extremity Dysfunction, run by Kessler Foundation at 1 site in United States.
Trial summary
To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SCI - Spinal Cord Injury, Upper Extremity Dysfunction, Upper Extremity Problem
- What is being tested?
- MyoMo and conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2023to 1 Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 ages 18-80
- Be able to activate certain muscles in my arm and forearm on my own a sufficient amount as measured by EMG amplitude. This will be determined by the study OT/PT.
- Be diagnosed with spinal cord injury (SCI) with level C1-C8 and ASIA Impairment Scale (AIS) C or D, as determined by study staff. If I have not had an exam to determine my injury level and impairment scale recently, I may participate in an examination of my sensation and strength in my arms, legs, trunk and rectum as was done in the hospital soon after my injury.
- Be at least 1-year post injury
- Have sufficient ability to move my shoulder (active shoulder flexion of 30 degrees and active shoulder abduction 20 degrees), as determined by study staff
- Be medically stable
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- Have sufficient learning and memory abilities and abilities to communicate in English to be able to participate and follow directions during my rehabilitation
- Continue to take all prescribed medication (e.g., oral or via pump baclofen) without any dosing changes
- Be able to tolerate functional tasks for 60 minutes with periodic rests without excessive fatigue
- Have minimal strength in the muscles that bend and straighten my elbow, as determined by study staff
- Have full range of motion in my elbow when it is moved by the study therapist
Who cannot join
- Be younger than 18 years old or older than 80
- Have excessive pain in my arm, wrist, or hand that limits providing rehabilitation
- Have excessive spasticity in my elbow or wrist, as determined by study staff
- Be participating in any experimental rehabilitation or drug studies
- Have history of nervous system disorder other than SCI
- Have difficulty following multiple step directions
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- Have severe cognitive or psychiatric problems might be contraindications to start training.
- Have skin issues or severe sensory deficits that would prevent wearing the Myo-Pro device safely
- Be pregnant
- Have other conditions or circumstances that, in the opinion of the investigators, would affect the safety or effectiveness of the training in which I would participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Ghaith J Androwis, Ph.D., 201-968-6110, gandrowis@kesslerfoundation.org
About this study
To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study.
Read the detailed description
Spinal cord injury (SCI) is a medically complex and life-disrupting condition. Each year in the United States, it is estimated that 17,700 new traumatic SCI cases are reported, including many active service men and women, and veterans. About half of those, the injury involve some part of the arm and hand, representing significant disability and dependence for those patients and their families. When arms/hands are impaired, the patient's quality of life and level of independence are reduced. The proposed RCT investigation will evaluate the long-term effects of the UE-MPWO (MyoPro) in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with SCI. This MyoPro orthosis can assist elbow and hand function with built-in motors that are activated by patients' intended motion, as represented by the residue voluntary muscle activities detected by the device's sensors.
The impact of the data generated from this clinical trial investigation should advance the application of new orthotic and prosthetic technologies to treating disabilities as a result of injuries or diseases such as SCI and promote home and community uses of the technologies to improve daily function and independence. The study would also advance scientific knowledge regarding neural changes occurring in the nervous system by application of the technology. The learned knowledge from this investigation will further justify the utilization of such an orthotic technology for individuals with SCI.
Beyond the common therapeutic benefits of upper extremity motor function rehabilitation and assistance for daily living provided with utilization of the MyoPro orthotic device, there may be additional benefits including improvements in quality of life and activity of daily living due to recovered function by using the device. The clinical trial investigation described in this application would provide clinicians and therapists with an initial, but stronger basis for integrating such an orthosis into regimens for managing upper extremity impairments in persons with SCI. This would represent a significant improvement to the existing paradigms of treating hand/arm disabilities in persons with SCI. The benefits, for the patients and society (including the VA community), of utilizing such an orthotic device during daily activities at home and in the community far outweigh the minimal risks associated with this FDA-approved orthosis, particularly as those minimal risks have been minimized by using sound research methodologies.
- Being tested
- MyoMo, conventional therapy
- 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.
MyoMoDevice
To evaluate the usefulness of extended utilization of an upper extremity assistive device, called (MyoPro) in improving upper extremity (UE) activities in people with spinal cord injury (SCI).
conventional therapyOther
To evaluate the usefulness of extended conventional therapy compared to the utilization of an upper extremity assistive device called (MyoPro) in improving upper extremity (UE) activities in people with spinal cord injury.
| Study group | Role | What they receive |
|---|---|---|
| MyoPro | Experimental | Receiving MyoMo training in-clinic for 6 weeks, and continuing MyoMo training in-clinic and at home for another 6 weeks. Receives: Device: MyoMo |
| Control | Active comparator | Receiving conventional therapy in-clinic and using their prescribed static brace (or others) for 6 weeks, and continuing the conventional therapy in-clinic and home using their prescribed static brace (or others) at home for 6 weeks. Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GRASSP
Assessment of the Hand in Tetraplegia Using the Graded Redefined Assessment of Strength Sensibility and Prehension Upper Extremity (UE) 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 36 weeks
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 36 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 36 weeks
Secondary outcomes (3)
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
Measured: Approximately 36 weeks
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 36 weeks
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.
Measured: Approximately 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start15 Oct 2023
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (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.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Randomized Clinical Trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghaith J. Androwis, Ph.D., Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349434
- Sponsor's protocol ID
- R-1215-23
- Status last verified
- Nov 2025
- First submitted
- 1 Apr 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI
- ClinicalTrials.gov ID
- NCT06349434
- Acronym / sponsor ID
- R-1215-23
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 5 Apr 2024 (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.
To evaluate the usefulness of an upper extremity assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury. The Department of Defense is supporting this study.
Detailed description
Spinal cord injury (SCI) is a medically complex and life-disrupting condition. Each year in the United States, it is estimated that 17,700 new traumatic SCI cases are reported, including many active service men and women, and veterans. About half of those, the injury involve some part of the arm and hand, representing significant disability and dependence for those patients and their families. When arms/hands are impaired, the patient's quality of life and level of independence are reduced. The proposed RCT investigation will evaluate the long-term effects of the UE-MPWO (MyoPro) in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with SCI. This MyoPro orthosis can assist elbow and hand function with built-in motors that are activated by patients' intended motion, as represented by the residue voluntary muscle activities detected by the device's sensors.
The impact of the data generated from this clinical trial investigation should advance the application of new orthotic and prosthetic technologies to treating disabilities as a result of injuries or diseases such as SCI and promote home and community uses of the technologies to improve daily function and independence. The study would also advance scientific knowledge regarding neural changes occurring in the nervous system by application of the technology. The learned knowledge from this investigation will further justify the utilization of such an orthotic technology for individuals with SCI.
Beyond the common therapeutic benefits of upper extremity motor function rehabilitation and assistance for daily living provided with utilization of the MyoPro orthotic device, there may be additional benefits including improvements in quality of life and activity of daily living due to recovered function by using the device. The clinical trial investigation described in this application would provide clinicians and therapists with an initial, but stronger basis for integrating such an orthosis into regimens for managing upper extremity impairments in persons with SCI. This would represent a significant improvement to the existing paradigms of treating hand/arm disabilities in persons with SCI. The benefits, for the patients and society (including the VA community), of utilizing such an orthotic device during daily activities at home and in the community far outweigh the minimal risks associated with this FDA-approved orthosis, particularly as those minimal risks have been minimized by using sound research methodologies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| MyoPro | Experimental | Device: MyoMoReceiving MyoMo training in-clinic for 6 weeks, and continuing MyoMo training in-clinic and at home for another 6 weeks. |
| Control | Active comparator | Other: conventional therapyReceiving conventional therapy in-clinic and using their prescribed static brace (or others) for 6 weeks, and continuing the conventional therapy in-clinic and home using their prescribed static brace (or others) at home for 6 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Be between ages 18-80
- Be able to activate certain muscles in my arm and forearm on my own a sufficient amount as measured by EMG amplitude. This will be determined by the study OT/PT.
- Be diagnosed with spinal cord injury (SCI) with level C1-C8 and ASIA Impairment Scale (AIS) C or D, as determined by study staff. If I have not had an exam to determine my injury level and impairment scale recently, I may participate in an examination of my sensation and strength in my arms, legs, trunk and rectum as was done in the hospital soon after my injury.
- Be at least 1-year post injury
- Have sufficient ability to move my shoulder (active shoulder flexion of 30 degrees and active shoulder abduction 20 degrees), as determined by study staff
Key exclusion criteria (10 listed)
- Be younger than 18 years old or older than 80
- Have excessive pain in my arm, wrist, or hand that limits providing rehabilitation
- Have excessive spasticity in my elbow or wrist, as determined by study staff
- Be participating in any experimental rehabilitation or drug studies
- Have history of nervous system disorder other than SCI
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 |
|---|---|---|
| MyoMoTo evaluate the usefulness of extended utilization of an upper extremity assistive device, called (MyoPro) in improving upper extremity (UE) activities in people with spinal cord injury (SCI). | Device | MyoPro |
| conventional therapyTo evaluate the usefulness of extended conventional therapy compared to the utilization of an upper extremity assistive device called (MyoPro) in improving upper extremity (UE) activities in people with spinal cord injury. | Other | Control |
Primary outcome
GRASSP
Time frame: Approximately 36 weeks
Assessment of the Hand in Tetraplegia Using the Graded Redefined Assessment of Strength Sensibility and Prehension Upper Extremity (UE) 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.
Range of motion of hands and arms
Time frame: Approximately 36 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 36 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.
3 secondary outcomes
Spasticity measurement
Time frame: Approximately 36 weeks
Brain signals measurement
Time frame: Approximately 36 weeks
CUE-Q
Time frame: Approximately 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyoMo and conventional therapy in people with SCI - Spinal Cord Injury and Upper Extremity Dysfunction, 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
GRASSP (time frame: Approximately 36 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 24 Nov 2025.