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

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.

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Upper Limb Weakness Due to Central Neurologic Injury
Intervention / Treatment

-

Contacts and Locations

Edmonds

Orthocare Innovations, LLC, Edmonds, Washington, United States, 98020

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Orthocare Innovations, LLC,

David Boone, PhD, PRINCIPAL_INVESTIGATOR, Orthocare Innovations, LLC

Study Record Dates

2024-03-01