SCI - Spinal Cord InjuryMyoMo in SCINCT04855812
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
A study testing MyoMo and Myo-SB in people with SCI - Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
Trial 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) 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 and Myo-SB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2019to 30 Sep 2023
- Phase
- Interventional
- 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 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
Read the 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.
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- MyoMo, Myo-SB, 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.
MyoMoDevice
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).
Myo-SBOther
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).
ControlOther
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).
| Study group | Role | What they receive |
|---|---|---|
| MyoPro | Experimental | Receiving MyoMo training in-clinic and at home for 6-weeks Receives: Device: MyoMo |
| Myo-SB | Active comparator | Receiving MyoMo training in-clinic and using their prescribed static brace (or others) at home for 6-weeks Receives: Other: Myo-SB |
| Control | Active comparator | Receiving conventional therapy/training in-clinic and using their prescribed static brace (or others) at home for 6-weeks 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
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
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
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 10 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 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start27 Oct 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized Clinical Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855812
- Sponsor's protocol ID
- D-1028-18
- Acronym
- MyoMo in SCI
- Status last verified
- Apr 2024
- First submitted
- 3 Feb 2020
- Last updated
- 2 Apr 2024
- 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04855812
- Acronym / sponsor ID
- MyoMo in SCI / D-1028-18
- Conditions
- SCI - Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 27 Oct 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 22 Apr 2021 (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 (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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| MyoPro | Experimental | Device: MyoMoReceiving MyoMo training in-clinic and at home for 6-weeks |
| Myo-SB | Active comparator | Other: Myo-SBReceiving MyoMo training in-clinic and using their prescribed static brace (or others) at home for 6-weeks |
| Control | Active comparator | Other: ControlReceiving conventional therapy/training in-clinic and 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 (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
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 an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI). | Device | MyoPro |
| Myo-SBTo 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). | Other | Myo-SB |
| ControlTo 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). | 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.
Brain signals measurement
Time frame: Approximately 10 weeks
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
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.
Spasticity measurement
Time frame: Approximately 10 weeks
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 1. 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 2. More marked increase in muscle tone through most of the range of motion. 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
CUE-Q
Time frame: Approximately 10 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myo-SB 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 9 inclusion and 12 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: finished, as of the sponsor's last update on 2 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 6 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 2 Apr 2024.