Improving Myoelectric Prosthetic and Orthotic Limb Control

Hemiparesis Clinical Trial

Official title:

Improving Myoelectric Prosthetic and Orthotic Limb Control Using Predictive Regression Algorithms and High-count Surface Electrodes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05509101
• Other study ID #: IRB_00098851
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: University of Utah
• Contact: Heidi Hansen, BS
• Phone: 801.585.2373
• Email: heidi.hansen[@]hsc.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis
• Paresis

Intervention

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

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Box and Blocks Test (BBT)	The Box and Blocks test is performed using the orthotic device under each condition. The individual puts on the device for a maximum of two hours. During that time wearing the device, they will use two different algorithms for controlling the device to complete the Box and Blocks Test.	while using the device (up to 2 hours)