MedTrace Logo

Functional Electrical Stimulation (FES) Cycling for Children With Spinal Cord Injuries (SCI)

NCT00245726 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2009-02-02

No results posted yet for this study

Summary

The overall objective of this research project is to examine the clinical efficacy of lower extremity cycling with functional electrical stimulation to improve the health and fitness of children with spinal cord injuries (SCI). To achieve this goal, a controlled, randomized study will be conducted with thirty children who have sustained a spinal cord injury. The children in the study will be assigned to one of three groups: those receiving functional electrical stimulation (FES) leg cycling exercise, those receiving passive leg cycling, and a non-cycling control group receiving electrical stimulation therapy to generate muscle contractions in the lower extremity. All three groups will be balanced as to the amount of time they receive the specific therapy. All therapies, after initial assessment, will be conducted at home in order to foster changes in lifestyle that may prove to be essential for improved quality of life.

The specific aims of this proposal are delineated below:

Aim 1: To assess, by means of a randomized controlled study design, the ability of FES cycling to improve the cardiovascular and musculoskeletal systems of ten children with a spinal cord injury, as compared to ten children undergoing passive leg cycling exercise and ten children receiving electrical stimulation therapy alone.

Aim 2: To determine, by means of a randomized controlled study design, the feasibility of using FES leg cycling exercise to provide long-term health benefits and improve the neurologic status of ten children with a spinal cord injury, as compared to ten children undergoing passive leg cycling exercise and ten children receiving electrical stimulation therapy alone.

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

FES Cycle

Subjects will use electrical stimulation of the leg muscles to pedal a cycle for 1 hour / 3x week

DEVICE

ES therapy

Subjects will electrically stimulate the leg muscles for 1 hour/ 3x week

DEVICE

Passive (Motor Assist) Cycle

Subjects will use a cycle that moves the legs for 1 hour/3x per week

Sponsors & Collaborators

  • Shriners Hospitals for Children

    lead OTHER

Principal Investigators

  • Richard Lauer, PhD · Shriners Hospitals for Children

  • John W McDonald, MD, PhD · Kennedy Kreiger Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

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 NCT00245726 on ClinicalTrials.gov