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NCT00245726 · ClinicalTrials.gov registry record · NA
Functional Electrical Stimulation (FES) Cycling for Children With Spinal Cord Injuries (SCI)
A NA study, sponsored by Shriners Hospitals for Children.
- Completed
- Registry status
- NA
- Development phase
- 30
- Enrollment target
NCT00245726 is a NA study that has completed, run by Shriners Hospitals for Children. The registered enrollment target is 30 participants.
The verdict
NCT00245726, a NA study, has completed, sponsored by Shriners Hospitals for Children.
- COMPLETED
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
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.
Interventions
- DEVICE FES Cycle
- DEVICE ES therapy
- DEVICE Passive (Motor Assist) Cycle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2004-03 |
| Est. Completion | 2008-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00245726
The ClinicalTrials.gov registry entry for NCT00245726 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shriners Hospitals for Children, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which FES Cycle is the first listed.
NCT00245726 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00245726 about?
NCT00245726 is a clinical study titled "Functional Electrical Stimulation (FES) Cycling for Children With Spinal Cord Injuries (SCI)". 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 w...
What is the current status of trial NCT00245726?
This trial is currently completed. It is a NA study. The enrollment target is 30 participants. The study started on 2004-03. Estimated completion is 2008-06.
What interventions are being tested in trial NCT00245726?
The interventions under investigation include: FES Cycle (DEVICE), ES therapy (DEVICE), Passive (Motor Assist) Cycle (DEVICE).
Who is sponsoring clinical trial NCT00245726?
This trial is sponsored by Shriners Hospitals for Children, which has 40 total clinical trials registered on ClinicalTrials.gov.
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