mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation
Launched by ORTHOCARE INNOVATIONS, LLC · Aug 28, 2023
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
The mGain trial is studying a new therapy to help people with weakness in their arms due to conditions like stroke, nerve injuries, or even after limb amputation. The therapy uses a special device that connects to a mobile app and provides feedback to make exercises more engaging and fun. Researchers believe that this approach will encourage participants to stick to their therapy better than traditional methods. The study will last for four weeks, with participants doing therapy for 30 minutes a day, five days a week, and they will visit a study site at the beginning and end for assessments.
To join the trial, participants need to be 18 years or older and have some weakness in their arms due to specific conditions, such as recent nerve injuries or amputations. They should also be able to use a smartphone or tablet and commit to the exercise routine. This is an exciting opportunity for those who qualify, as it may not only improve their upper limb function but also provide a more enjoyable way to do therapy.
Gender
ALL
Eligibility 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
About Orthocare Innovations, Llc
Orthocare Innovations, LLC is a leading clinical trial sponsor specializing in the development and commercialization of advanced orthopedic technologies. Focused on enhancing patient outcomes, the company leverages innovative research and cutting-edge methodologies to create solutions that address critical challenges in musculoskeletal health. With a commitment to scientific rigor and ethical standards, Orthocare Innovations collaborates with healthcare professionals and research institutions to conduct clinical trials that pave the way for transformative therapies in orthopedic care. Their expertise extends across various therapeutic areas, emphasizing the importance of evidence-based practices in improving patient quality of life.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Edmonds, Washington, United States
Patients applied
Trial Officials
David Boone, PhD
Principal Investigator
Orthocare Innovations, LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported