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Search / Trial NCT06023316

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.

Locations

Edmonds, Washington, United States

Patients applied

0 patients applied

Trial Officials

David Boone, PhD

Principal Investigator

Orthocare Innovations, LLC

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported