FindMyKOL
Clinical trialNCT00245726CompletedInterventional

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

SponsorShriners Hospitals for ChildrenEnrollment30Spinal Cord Injury
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Kennedy Krieger Institute

    Baltimore, Maryland, United States

  • Shriners Hospitals for Children

    Philadelphia, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2004
Primary completion
30 Jun 2008
Completion
30 Jun 2008
Last update posted
2 Feb 2009
Registered enrollment
30
Registry id
NCT00245726

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.