Upper Limb Weakness Due to Central Neurologic InjuryNCT06023316
mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
A study testing mGain system in people with Upper Limb Weakness Due to Central Neurologic Injury and Upper Limb Weakness Due to Peripheral Neurologic Injury, run by Orthocare Innovations, LLC at 1 site in United States.
Trial summary
The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides biofeedback-based therapy in individuals with upper limb weakness due to neurologic injury or with upper limb amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury, Upper Limb Weakness Due to Nerve Reconstruction
- What is being tested?
- mGain system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to 1 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Upper limb weakness due to central or peripheral neurologic injury, stroke, or nerve reconstruction or tendon transfer surgery within one year; or upper limb amputation (e.g., transradial or transhumeral)
- Muscle strength of three or less on the Medical Research Council Manual Muscle Testing grading scale in any of the following (as appropriate for individuals with intact limbs): shoulder abduction, elbow flexion, elbow extension, wrist extension, wrist flexion, or finger extension
- Access to and willingness to use smart phone or tablet
- Able to tolerate participation in activity for at least 30 minutes of therapy exercises per day for five days per week
- Able to provide written informed consent for study participation
Who cannot join
- Not able to read and understand English
- Pregnancy
- History of prior central or peripheral neurologic injury or neuromuscular condition
- No muscle activation detectable by the mGain sEMG sensor
- Progressive neurologic deficit
- Impaired dexterity on the contralateral side such that participant is unable to use the device
Show all 11Show fewer
- Spasticity with modified Ashworth score of three or greater
- Severe joint contracture (>50% of available range)
- Sensitive skin that would not tolerate wearing the mGain sEMG sensor
- Medical instability
- Confounding injury, musculoskeletal issues, or cognitive issues that limit effective participation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Orthocare Innovations, LLC
Edmonds, Washington, 98020
Adam Arabian, PhD, 425-771-0797, arabian@orthocareinnovations.com
About this study
The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides biofeedback-based therapy in individuals with upper limb weakness due to neurologic injury or with upper limb amputation. Our overarching hypothesis is that the mGain wireless sEMG device and mobile therapeutic gaming environment will demonstrate improved adherence to therapy when compared to standard of care and will be feasible, acceptable, and usable in individuals with upper limb weakness or limb amputation.
All participants will undertake four weeks of therapy. Conducting therapy five days a week for 30 minutes a day. In addition, participants will have an initial and final assessment visit at a study site, with each visit expected to last 1-2 hours.
Read the detailed description
All participants will undertake four weeks of therapy. Conducting therapy five days a week for 30 minutes a day. In addition, participants will have an initial and final assessment visit at a study site, with each visit expected to last 1-2 hours.
Initial Assessment: Eligible individuals will complete a baseline assessment including range of motion, manual muscle testing, and handheld dynamometry of the target limb(s). Target muscles for therapy will be identified (e.g., biceps, triceps, deltoids, forearm flexors, forearm extensors) and a trial of sEMG evaluation to detect muscle signal will be conducted. If detectable muscle signal is present, participants will complete the consent process and be enrolled in the study. Each participant will be taught the use of the mGain system using their own mobile phone or tablet and be given a therapeutic regimen to target their individual muscle weakness. Participants will then be asked to demonstrate use of the system. Participants can ask questions to ensure they understand system usage and the expectations when at home. Participants will complete baseline validated outcome measures such as the QuickDASH (Disabilities of the Arm, Shoulder and Hand questionnaire) and PROMIS Self-Efficacy Scale.
Home Therapy: For the four weeks following the initial assessment, participants will be asked to conduct a minimum of 30 minutes of therapy per day, 5 days a week, at home using the mGain system targeting the muscles identified during the initial assessment. Individuals will be asked to complete short questionnaires and write in an eDiary about their experience after conducting their daily exercises. A member of the study team will contact the participants on a weekly basis to provide technical support, inquire about adherence, and encourage participation. Data for each participant will be uploaded to Orthocare Innovations' HIPAA compliant cloud-based server.
Final Assessment: Participants will complete a final assessment of strength, range of motion, and manual muscle testing. Additionally, participants will complete outcome measures and surveys such as the QuickDASH, PROMIS Self-Efficacy, system usability scale, and a custom feasibility survey.
- Conditions
- Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury, Upper Limb Weakness Due to Nerve Reconstruction, Upper Limb Weakness Due to Tendon Transfer Surgery, Stroke, Upper Limb Amputation
- Being tested
- mGain system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mGain systemDevice
passive, noninvasive surface electromyography measurement device and gaming mobile application
| Study group | Role | What they receive |
|---|---|---|
| mGain system | Experimental | mGain system: passive, noninvasive, Bluetooth-enabled, wire-free, surface electromyography measurement device that provides input to a mobile app for an interactive gaming platform Receives: Device: mGain system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre Self-Efficacy
The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.
Measured: At initial assessment before using intervention
Post Self-Efficacy
The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.
Measured: Four weeks (at final assessment after using intervention for four weeks)
System Usability Scale
The System Usability Scale measures the usability of a system and is a 10-item questionnaire completed by the participant; results in score 0-100 where scores above 68 would be considered above average.
Measured: Four weeks (at final assessment after using intervention for four weeks)
Secondary outcomes (2)
pre-QuickDASH
QuickDASH (Disabilities of the Arm, Shoulder and Hand) is a validated patient-reported questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb; results in score 0-100 where 0 represents the least disability and 100 represents the greatest disability
Measured: At initial assessment before using intervention
post-QuickDASH
QuickDASH is a validated patient-reported questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb; results in score 0-100 where 0 represents the least disability and 100 represents the greatest disability
Measured: Four weeks (at final assessment after using intervention for four weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start8 Aug 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Limb Weakness Due to Central Neurologic 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthocare Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Sponsor
- Investigators
- David Boone, PhD, Principal investigator, Orthocare Innovations, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023316
- Sponsor's protocol ID
- mGain-001
- Status last verified
- Oct 2023
- First submitted
- 13 Aug 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
- ClinicalTrials.gov ID
- NCT06023316
- Acronym / sponsor ID
- mGain-001
- Conditions
- Upper Limb Weakness Due to Central Neurologic Injury, Upper Limb Weakness Due to Peripheral Neurologic Injury, Upper Limb Weakness Due to Nerve Reconstruction, Upper Limb Weakness Due to Tendon Transfer Surgery, Stroke, Upper Limb Amputation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Orthocare Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 5 Sep 2023 (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.
The purpose of this Phase I study is to conduct a pilot clinical trial using a mobile app-connected, wire-free surface electromyography (sEMG) system, called mGain, that provides biofeedback-based therapy in individuals with upper limb weakness due to neurologic injury or with upper limb amputation. Our overarching hypothesis is that the mGain wireless sEMG device and mobile therapeutic gaming environment will demonstrate improved adherence to therapy when compared to standard of care and will be feasible, acceptable, and usable in individuals with upper limb weakness or limb amputation.
All participants will undertake four weeks of therapy. Conducting therapy five days a week for 30 minutes a day. In addition, participants will have an initial and final assessment visit at a study site, with each visit expected to last 1-2 hours.
Detailed description
All participants will undertake four weeks of therapy. Conducting therapy five days a week for 30 minutes a day. In addition, participants will have an initial and final assessment visit at a study site, with each visit expected to last 1-2 hours.
Initial Assessment: Eligible individuals will complete a baseline assessment including range of motion, manual muscle testing, and handheld dynamometry of the target limb(s). Target muscles for therapy will be identified (e.g., biceps, triceps, deltoids, forearm flexors, forearm extensors) and a trial of sEMG evaluation to detect muscle signal will be conducted. If detectable muscle signal is present, participants will complete the consent process and be enrolled in the study. Each participant will be taught the use of the mGain system using their own mobile phone or tablet and be given a therapeutic regimen to target their individual muscle weakness. Participants will then be asked to demonstrate use of the system. Participants can ask questions to ensure they understand system usage and the expectations when at home. Participants will complete baseline validated outcome measures such as the QuickDASH (Disabilities of the Arm, Shoulder and Hand questionnaire) and PROMIS Self-Efficacy Scale.
Home Therapy: For the four weeks following the initial assessment, participants will be asked to conduct a minimum of 30 minutes of therapy per day, 5 days a week, at home using the mGain system targeting the muscles identified during the initial assessment. Individuals will be asked to complete short questionnaires and write in an eDiary about their experience after conducting their daily exercises. A member of the study team will contact the participants on a weekly basis to provide technical support, inquire about adherence, and encourage participation. Data for each participant will be uploaded to Orthocare Innovations' HIPAA compliant cloud-based server.
Final Assessment: Participants will complete a final assessment of strength, range of motion, and manual muscle testing. Additionally, participants will complete outcome measures and surveys such as the QuickDASH, PROMIS Self-Efficacy, system usability scale, and a custom feasibility survey.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mGain system | Experimental | Device: mGain systemmGain system: passive, noninvasive, Bluetooth-enabled, wire-free, surface electromyography measurement device that provides input to a mobile app for an interactive gaming platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- Upper limb weakness due to central or peripheral neurologic injury, stroke, or nerve reconstruction or tendon transfer surgery within one year; or upper limb amputation (e.g., transradial or transhumeral)
- Muscle strength of three or less on the Medical Research Council Manual Muscle Testing grading scale in any of the following (as appropriate for individuals with intact limbs): shoulder abduction, elbow flexion, elbow extension, wrist extension, wrist flexion, or finger extension
- Access to and willingness to use smart phone or tablet
- Able to tolerate participation in activity for at least 30 minutes of therapy exercises per day for five days per week
Key exclusion criteria (11 listed)
- Not able to read and understand English
- Pregnancy
- History of prior central or peripheral neurologic injury or neuromuscular condition
- No muscle activation detectable by the mGain sEMG sensor
- Progressive neurologic deficit
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 |
|---|---|---|
| mGain systempassive, noninvasive surface electromyography measurement device and gaming mobile application | Device | mGain system |
Primary outcome
Pre Self-Efficacy
Time frame: At initial assessment before using intervention
The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.
Post Self-Efficacy
Time frame: Four weeks (at final assessment after using intervention for four weeks)
The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.
System Usability Scale
Time frame: Four weeks (at final assessment after using intervention for four weeks)
The System Usability Scale measures the usability of a system and is a 10-item questionnaire completed by the participant; results in score 0-100 where scores above 68 would be considered above average.
2 secondary outcomes
pre-QuickDASH
Time frame: At initial assessment before using intervention
post-QuickDASH
Time frame: Four weeks (at final assessment after using intervention for four weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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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.
David Boone, PhD principal investigator
Orthocare Innovations, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mGain system in people with Upper Limb Weakness Due to Central Neurologic Injury and Upper Limb Weakness Due to Peripheral Neurologic Injury, run by Orthocare Innovations, LLC 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 6 inclusion and 11 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 10 Oct 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.
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?
Contact Adam Arabian, PhD (+1 (425) 771-0797, arabian@orthocareinnovations.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre Self-Efficacy (time frame: At initial assessment before using intervention). 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 10 Oct 2023.