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FES Assisted Cycling in Children With CP

NCT04688424 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-12-30

No results posted yet for this study

Summary

This project proposes to assess if Functional Electrical Stimulation (FES) assisted cycling can improve the cycling ability, muscle strength, cardiovascular health, quality of life, self perception and functional mobility of adolescents with CP better than a volitional cycling program or a non-intervention control group.

Conditions

  • Cerebral Palsy Spastic Diplegia

Interventions

DEVICE

FES

FES will be applied via surface electrodes placed over bilateral quadriceps muscles. FES-stimulation will be ramped from sensory level (the level at which the individual feels a cutaneous sensation from the stimulation) to the maximum-tolerated level using a closed loop system controlled by computer software Subjects will exercise at home, three times per week, with FES on for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.

OTHER

Cycling

Subjects will exercise at home, three times per week, without FES for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.

Sponsors & Collaborators

  • Shriners Hospitals for Children

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    lead NIH

Principal Investigators

  • Samuel Lee, PT, PhD · Physical Therapy Department, University of Delaware

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2016-06-30
Completion
2016-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04688424 on ClinicalTrials.gov