Gamified therapy using a mobile app for upper limb rehabilitation
mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
NA · Orthocare Innovations, LLC · NCT06023316
This study is testing a new mobile app and device to see if it can help people with upper limb weakness from injuries or amputations do their therapy better than usual care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Orthocare Innovations, LLC (industry) |
| Locations | 1 site (Edmonds, Washington) |
| Trial ID | NCT06023316 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial evaluates the mGain system, a mobile app-connected, wire-free surface electromyography (sEMG) device designed to provide biofeedback-based therapy for individuals with upper limb weakness due to various neurologic injuries or limb amputation. Participants will engage in a four-week therapy regimen, conducting sessions five days a week for 30 minutes each, while receiving initial and final assessments at a study site. The study aims to determine the feasibility, acceptability, and usability of the mGain system compared to standard care, focusing on improving adherence to therapy. Participants will also complete validated outcome measures to assess their progress.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with upper limb weakness due to neurologic injury, stroke, nerve reconstruction, tendon transfer surgery, or upper limb amputation.
Not a fit: Patients who do not have detectable muscle activation or those with prior neurologic conditions may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could significantly enhance rehabilitation outcomes for patients with upper limb weakness, improving their functional abilities and quality of life.
How similar studies have performed: While this approach is innovative, similar studies utilizing biofeedback and gamified therapy have shown promise in improving rehabilitation outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Edmonds, Washington
- Orthocare Innovations, LLC — Edmonds, Washington, United States (RECRUITING)
Study contacts
- Principal investigator: David Boone, PhD — Orthocare Innovations, LLC
- Study coordinator: Adam Arabian, PhD
- Email: arabian@orthocareinnovations.com
- Phone: +1 (425) 771-0797
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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