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

NCT06023316 | Unknown FDA Device

• 1 other identifier: mGain-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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; Upper Limb Amputation

Outcome Measures

Primary Outcomes (3)

• Pre Self-Efficacy

  The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.

  At initial assessment before using intervention

• Post Self-Efficacy

  The PROMIS Self-Efficacy is a validated patient-reported questionnaire that measures an individual's confidence in the ability to perform specific tasks or behaviors in a variety of situations; developed under the Patient-Reported Outcomes Measurement Information System (PROMIS) program; results in a T-score where 50 is the mean and T-scores below the mean indicate less self-efficacy.

  Four weeks (at final assessment after using intervention for four weeks)

• System Usability Scale

  The System Usability Scale measures the usability of a system and is a 10-item questionnaire completed by the participant; results in score 0-100 where scores above 68 would be considered above average.

  Four weeks (at final assessment after using intervention for four weeks)

Secondary Outcomes (2)

• pre-QuickDASH

  At initial assessment before using intervention

• post-QuickDASH

  Four weeks (at final assessment after using intervention for four weeks)

Study Arms (1)

mGain system

EXPERIMENTAL

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

Device: mGain system

Interventions

mGain system DEVICE

passive, noninvasive surface electromyography measurement device and gaming mobile application

mGain system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthocare Innovations, LLC: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Orthocare Innovations, LLC

Edmonds, Washington, 98020, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Boone, PhD

  Orthocare Innovations, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adam Arabian, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: September 5, 2023
• Study Start: August 8, 2023
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)