Recruiting

mGain

Sponsor:

Orthocare Innovations, LLC

Code:

NCT06023316

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

mGain system

Study Details

Brief summary:

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

Study ID

NCT06023316

Start date

Aug 8, 2023

Status verified date

Oct, 2023

Completion date

Mar 1, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: mGain system

mGain system: passive, noninvasive, Bluetooth-enabled, wire-free, surface electromyography measurement device that provides input to a mobile app for an interactive gaming platform

Interventions

mGain system

passive, noninvasive surface electromyography measurement device and gaming mobile application

Primary outcome measure

  • Pre Self-Efficacy [ Time Frame: At initial assessment before using intervention ]
  • Post Self-Efficacy [ Time Frame: Four weeks (at final assessment after using intervention for four weeks) ]
  • System Usability Scale [ Time Frame: Four weeks (at final assessment after using intervention for four weeks) ]

Central Contacts and Locations

Central contacts

Adam Arabian, PhD

+1 (425) 771-0797arabian@orthocareinnovations.com

Locations

Orthocare Innovations, LLC

Recruiting

Edmonds, Washington, United States, 98020

Contacts

Adam Arabian, PhD

425-771-0797arabian@orthocareinnovations.com

More Information

Sponsor

Orthocare Innovations, LLC

Last update posted

Oct 10, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Orthocare Innovations, LLC on 2023-10-10.