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CompletedNCT04094571

Muscle Delay Characterization

Characterizing the Delayed Muscle Response to Electrical Stimulation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
13 (actual)
Sponsor
University of Florida · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

Functional electrical stimulation (FES) induced cycling is a common rehabilitative therapy. Closed-loop FES control holds the promise to improve rehabilitation procedures. However, FES results in a delay between the time of stimulation and muscle contraction and rapidly fatigues muscle. The purpose of this study is to measure the FES-induced delay on an FES cycle and to understand how the delay varies as a function of how long the user has been cycling and a function of the crank angle.

Detailed description

This study will use non-invasive approaches (surface electrodes, encoders, torque meters, motors) to study muscle delay and how muscle fatigues for both individuals possessing movement disorders and healthy individuals. Individuals with movement disorders are often susceptible to partial or total paralysis. This paralysis often leads to an increasingly sedentary lifestyle. By implementing the intelligent closed-loop control of FES-cycling, FES-therapy can be made more effective, combating the effects of sedentary lifestyles. Using data obtained from non-invasive sensors, the study team will apply analytical techniques to quantify FES muscle delay and how well individuals can track a desired cadence as the muscle fatigues. A challenge associated with FES-induced cycling is that there exists a delay between the time when FES is applied and the time when the muscle contracts. There is likewise a delay between the time FES is removed and the time the muscle ceases to contract. Previous studies have measured this delay and determined that it varies with fatigue. A goal of this project is to measure this delay on an FES-cycle and to determine how this delay varies as a result of FES-induced cycling. Another goal is to determine what effect the crank angle has on the delay as well as on the muscle control effectiveness. This study will provide insight into how engineering can be combined with healthcare and therapy to better both fields and bridge the gap between engineering and medicine.

Conditions

Interventions

TypeNameDescription
DEVICEFunctional Electrical Stimulation (FES) Control ProtocolTo measure the delay, the motor will take the tricycle crank to pre-specified angles and then hold that position while various combinations of the quadriceps femoris and the gluteal muscle groups are stimulated in study participants.
DEVICEFunctional Electrical Stimulation (FES) Angle ProtocolTo determine the effect of the crank angle on the FES delay and the muscle control effectiveness, the crank is positioned at a pre-specified angle, with various muscle groups being stimulated while holding this position. The motor then takes the crank to another angle and the process is repeated.

Timeline

Start date
2019-10-01
Primary completion
2021-09-03
Completion
2021-09-03
First posted
2019-09-19
Last updated
2021-10-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04094571. Inclusion in this directory is not an endorsement.