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Behavioural Intervention

sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation

N/A

Recruiting

Led By David Boone, PhD

Research Sponsored by Orthocare Innovations, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up four weeks (at final assessment after using intervention for four weeks)

Awards & highlights

Study Summary

This trial tests a device & mobile gaming env. to improve therapy adherence in those w/ upper limb weakness or amputation. 4 wks of 30 min/day therapy, initial & final assessment visits.

Who is the study for?

This trial is for adults with upper limb weakness or amputation due to neurological injury, stroke, or surgery within the past year. Participants must have a certain level of muscle strength, be able to use a smartphone or tablet, and commit to daily therapy exercises. Excluded are those with high spasticity levels, inability to understand English, pregnancy, undetectable muscle activation by mGain sensor, medical instability that affects participation ability.Check my eligibility

What is being tested?

The study tests the mGain system—a wireless sEMG device connected to a mobile app providing biofeedback-based therapy games—for improving adherence and effectiveness in upper limb rehabilitation compared to standard care. Participants will undergo four weeks of daily 30-minute sessions plus initial and final assessments at the study site.See study design

What are the potential side effects?

Since this is not a drug trial but an intervention using a therapeutic gaming environment and sEMG technology for physical rehabilitation purposes, typical medication side effects are not expected. However, there may be discomfort from wearing the device on sensitive skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My muscle strength in key areas like my shoulders, elbows, wrists, or fingers is very weak.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four weeks (at final assessment after using intervention for four weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four weeks (at final assessment after using intervention for four weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and four weeks (at final assessment after using intervention for four weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Post Self-Efficacy

Pre Self-Efficacy

System Usability Scale

Secondary outcome measures

post-QuickDASH

pre-QuickDASH

Trial Design

1Treatment groups

Experimental Treatment

Group I: mGain systemExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Disability, Independent Living, and Rehabilitation ResearchFED

71 Previous Clinical Trials

9,099 Total Patients Enrolled

5 Trials studying Stroke

2,253 Patients Enrolled for Stroke

Orthocare Innovations, LLCLead Sponsor

8 Previous Clinical Trials

244 Total Patients Enrolled

3 Trials studying Stroke

130 Patients Enrolled for Stroke

David Boone, PhDPrincipal InvestigatorOrthocare Innovations, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for potential participants of this investigation?

"Affirmative, the information hosted on clinicaltrials.gov confirms that this medical trial is in its recruitment phase. It was first uploaded to the platform on August 8th 2023 and has been amended most recently on August 28th 2023. 30 patients are needed from a single center for this experiment."

Answered by AI

How many participants have joined the clinical trial thus far?

"Confirmed. According to clinicaltrials.gov, the study that launched on August 8th 2023 is currently recruiting individuals for participation. The recruitment target is 30 subjects across one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "mGain - sEMG-based Gamified Therapy for Improved Upper Limb Rehabilitation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023316.