RECRUITING

mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation

Quick Facts

Study Start:2023-08-08
Study Completion:2024-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06023316

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 years or older
  2. * 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)
  3. * 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
  4. * Access to and willingness to use smart phone or tablet
  5. * Able to tolerate participation in activity for at least 30 minutes of therapy exercises per day for five days per week
  6. * Able to provide written informed consent for study participation
  1. * Not able to read and understand English
  2. * Pregnancy
  3. * History of prior central or peripheral neurologic injury or neuromuscular condition
  4. * No muscle activation detectable by the mGain sEMG sensor
  5. * Progressive neurologic deficit
  6. * Impaired dexterity on the contralateral side such that participant is unable to use the device
  7. * Spasticity with modified Ashworth score of three or greater
  8. * Severe joint contracture (\>50% of available range)
  9. * Sensitive skin that would not tolerate wearing the mGain sEMG sensor
  10. * Medical instability
  11. * Confounding injury, musculoskeletal issues, or cognitive issues that limit effective participation

Contacts and Locations

Study Contact

Adam Arabian, PhD
CONTACT
+1 (425) 771-0797
arabian@orthocareinnovations.com

Principal Investigator

David Boone, PhD
PRINCIPAL_INVESTIGATOR
Orthocare Innovations, LLC

Study Locations (Sites)

Orthocare Innovations, LLC
Edmonds, Washington, 98020
United States

Collaborators and Investigators

Sponsor: Orthocare Innovations, LLC

  • David Boone, PhD, PRINCIPAL_INVESTIGATOR, Orthocare Innovations, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-08
Study Completion Date2024-03-01

Study Record Updates

Study Start Date2023-08-08
Study Completion Date2024-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • 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