Muscle Delay Characterization

Characterizing the Delayed Muscle Response to Electrical Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Neurological Disorders
• Intervention / Treatment: Device: Functional Electrical Stimulation (FES) Control Protocol; Device: Functional Electrical Stimulation (FES) Angle Protocol

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32603
      • NCR lab in MAE-B building at the University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy normal individuals aged 18-65 and individuals with movement disorders (e.g., spinal cord injury, Parkinson's disease, stroke)
• capable to perform the cycling exercises either voluntarily or under controlled electrical stimulation
• all participants have to be medically stable (i.e., do not exhibit asymptomatic osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with testing or training)
• for neurologically impaired individuals, they should have a single neurologic condition
• under all situations the body size and weight of participant has to be compatible with the testing apparatus to ensure safety at all times

Exclusion Criteria:

• participants who are unresponsive to surface FES are not considered eligible for the study
• a history of significant cardiovascular disorders, chronic arterial diseases or congestive cardiac failure, including being medicated for hypertension and/or have an implanted pacemaker
• have a history of major musculoskeletal problems that limit hip and knee extension such as orthopedic surgery, including ACL reconstruction and/or joint replacements
• participants with denervated muscle, severe osteoporosis or abnormal bone formation in hip/knee joints, bone fractures, acute hernia, severe muscle spasticity, infection in the lower extremities, epilepsy, diabetes, severe angina, pressure ulcers, vein thrombosis, and any ailments causing high fever, high blood pressure or high heart rate
• pregnant women, children/minors, adults with diminished decision-making capacity, and non-English speakers
• under all situations the body size and weight of participant has to be compatible with the testing apparatus to ensure safety at all times

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Healthy Individuals and those with Movement Disorders; Participants will perform the FES cycling protocol along with the FES angle protocol.

Device: Functional Electrical Stimulation (FES) Control Protocol; To 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.; Other Names: FES modified TerraTrike Rover recumbent tricycle; Device: Functional Electrical Stimulation (FES) Angle Protocol; To 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.; Other Names: FES modified TerraTrike Rover recumbent tricycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measure of crank torque	A torque meter (SRM Science PowerMeter) is attached to the tricycle's crank to provide instantaneous feedback of the rider torque. A combination of muscle groups will be stimulated and the resulting crank torque will be measured by the meter.	Day 1

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Science Foundation
• Investigators: Principal Investigator: Warren Dixon, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): September 3, 2021
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: functional electrical stimulation; rehabilitation
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: IRB201901676 -N; 1762829 (Other Grant/Funding Number: National Science Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No