Muscle Delay Characterization

NCT04094571 | Completed

• 2 other identifiers: IRB201901676 -N1762829
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurological Disorders

Keywords

functional electrical stimulation; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy Individuals and those with Movement Disorders

EXPERIMENTAL

Participants will perform the FES cycling protocol along with the FES angle protocol.

Device: Functional Electrical Stimulation (FES) Control Protocol; Device: Functional Electrical Stimulation (FES) Angle Protocol

Interventions

Functional Electrical Stimulation (FES) Control Protocol DEVICE

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.

Also known as: FES modified TerraTrike Rover recumbent tricycle

Healthy Individuals and those with Movement Disorders

Functional Electrical Stimulation (FES) Angle Protocol DEVICE

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.

Also known as: FES modified TerraTrike Rover recumbent tricycle

Healthy Individuals and those with Movement Disorders

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Science Foundation: collaborator

Study Sites (1)

NCR lab in MAE-B building at the University of Florida

Gainesville, Florida, 32603, United States

Location

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Warren Dixon, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: October 1, 2019
• Primary Completion: September 3, 2021
• Study Completion: September 3, 2021
• Last Updated: October 6, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)