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

NCT06023316 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-10-10

No results posted yet for this study

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

Interventions

DEVICE

mGain system

passive, noninvasive surface electromyography measurement device and gaming mobile application

Sponsors & Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research

    collaborator FED

  • Orthocare Innovations, LLC

    lead INDUSTRY

Principal Investigators

  • David Boone, PhD · Orthocare Innovations, LLC

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-08
Primary Completion
2023-12-31
Completion
2024-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06023316 on ClinicalTrials.gov