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NCT01244594 · ClinicalTrials.gov registry record · Phase 2
The Effects of Two Functional Electrical Stimulation Cycling Paradigms
A Phase 2 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT01244594: Completed Phase 2 study, sponsored by Thomas Jefferson University.
NCT01244594 is a Phase 2 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01244594, a Phase 2 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Background: People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way to obtain exercise after SCI. However, cycling with FES has only been done one way, which involves pedaling more quickly with less force to work against. Pedaling more slowly would allow the person to work against more force, which may lead to greater improvements in bone mineral density and muscle size. It may also lead to greater changes in bone make-up, body fat, and cholesterol levels. All of these improvements may lead to a decrease in bone fractures and cardiovascular disease, two major medical issues that exist in the SCI population. Study Aims: This study will compare the outcomes on bone, muscle and cardiovascular health between the commonly used method of pedaling more quickly to a new method of pedaling more slowly. Both groups will work against the maximal force possible. It is expected that the group pedaling more slowly will work against greater force and thus will have improved outcomes compared to other group pedaling faster. Methods: Twenty people with SCI, ages 18-65 years, will be randomly assigned to a treatment group and will participate in three 60-minute sessions per week for 6 months at an outpatient rehabilitation center. All subjects must have complete paralysis of both legs, but may have sensation preserved. Before and after 6 months of exercise, subjects will have an MRI scan to assess muscle size and bone, a dexascan to assess bone, a strength test using electrical stimulation to assess muscle force, an analysis of fat free body tissue, and lab work to measure cholesterol, bone factors that provide insight into bone change, and nutritional status. Relevance: If the protocol of pedaling more slowly results in greater improvements, this technique can be applied to clinical practice. Some people with SCI have FES cycles in their homes and many
Primary Outcome
Bone is measured using dexascan and Magnetic Resonance Imaging (MRI) to examine different types of bone (cortical and trabecular).
Interventions
- OTHER Cycling with functional electrical stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT01244594 record still lists
NCT01244594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Cycling with functional electrical stimulation is the first listed.
NCT01244594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01244594 about?
NCT01244594 is a clinical study titled "The Effects of Two Functional Electrical Stimulation Cycling Paradigms". Background: People with spinal cord injury (SCI) are at risk for many health conditions, some of which can be decreased with exercise. Cycling with Functional Electrical Stimulation (FES) is one way to obtain exercise after SCI. However, cycling with FES has only been done one way, which involves p...
What is the current status of trial NCT01244594?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2010-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01244594?
The interventions under investigation include: Cycling with functional electrical stimulation (OTHER).
Who is sponsoring clinical trial NCT01244594?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01244594's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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