Improving Myoelectric Prosthetic and Orthotic Limb Control

NCT ID: NCT05509101

Last Updated: 2023-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2025-08-31

Brief Summary

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The purpose of this study is to improve control of myoelectrically-controlled advanced orthotic devices (an exoskeleton device that use the body's muscle signals to drive movements of a robotic brace) by using advanced predictive decode algorithms, and the use of high count (\> 8) surface electromyographic (sEMG) electrodes.

Detailed Description

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This study looks to improve control of myoelectrically-controlled advanced powered orthoses (orthoses that use the body's muscle signals to drive movements of a robotic exoskeleton) by using advanced predictive decode algorithms, and the use of high count (\> 8) surface electromyographic (sEMG) electrodes.

Conditions

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Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Clinically Available Control Algorithm (MyoPro)

Binary control of the orthosis is based on a clinically available control algorithm. This condition serves as a control. Participants will use a commercially available device, the MyoPro.

Group Type ACTIVE_COMPARATOR

commercially available control algorithm

Intervention Type OTHER

Control of the prosthesis/orthosis is based on clinical standard of care using commercially available control algorithms.

High-Density EMG Control Algorithm

Control of the orthosis is based on residual muscle activity mapped to intended movement using advanced predicted algorithms. This condition is a novel algorithm and serves as the experimental condition.

Group Type EXPERIMENTAL

experimental control algorithm

Intervention Type OTHER

Control of the orthosis is based on residual muscle activity mapped to intended movement using high density electromyography and artificial intelligence control algorithms.

Interventions

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commercially available control algorithm

Control of the prosthesis/orthosis is based on clinical standard of care using commercially available control algorithms.

Intervention Type OTHER

experimental control algorithm

Control of the orthosis is based on residual muscle activity mapped to intended movement using high density electromyography and artificial intelligence control algorithms.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* First-ever ischemic or hemorrhagic stroke
* Chronic Stroke (at least 6 months since onset)
* Chronic hemiparesis
* Functional range of motion for contralateral arm

Exclusion Criteria

* Individuals who are currently Incarcerated
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Jacob George

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Heidi Hansen, BS

Role: CONTACT

801.585.2373

Jacob Wilson, BS

Role: CONTACT

801.581.8911

Facility Contacts

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Heidi Hansen

Role: primary

801-585-2373

Other Identifiers

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IRB_00098851

Identifier Type: -

Identifier Source: org_study_id

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