Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00255073 · ClinicalTrials.gov registry record · Phase 2
Does Reducing Spasticity Permit an Increase in Strength?
A Phase 2 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00255073 is a Phase 2 study that has completed, run by University of Southern California. The registered enrollment target is 10 participants.
The verdict
NCT00255073, a Phase 2 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
Reduction of spasticity has been a major focus of the treatment of childhood cerebral palsy, resulting in numerous treatment strategies that target various parts of the motor system. However, in many children weakness may be a greater contributor to disability than spasticity. Recent results suggest a correlation between spasticity and weakness, but it is not known if reduction of spasticity can improve strength. We suggest a simplified model in which spinal mechanisms (including reflex contributions to spasticity) and supraspinal mechanisms (including voluntary contributions to strength) combine to activate muscle. The model implies that the supraspinal contribution cannot increase unless the spinal contribution decreases. We therefore hypothesize that reduction of spasticity improves the ability to increase voluntary strength. We propose a double-masked placebo-controlled clinical trial combining treatment using the oral anti-spasticity medication baclofen with a 6-week program of strength training. We will enroll 20 ambulatory children with spastic diplegic cerebral palsy. Prior to and following the intervention, we will obtain quantitative measures of spasticity, strength, and gait. We predict that the children taking baclofen will have a greater increase in strength than the children taking placebo. We predict that the increase in strength will be reflected in improved performance on gait analysis, and it will correlate with a reduction in quantitative measures of spasticity and spinal reflex excitability. If the hypothesis is correct, it will provide important new information on the relationship between spasticity and strength in children with cerebral palsy. It will provide the first measurements of the effect of baclofen on voluntary muscle activation in children. It will support the short-term use of combined anti-spasticity medication and strengthening as a new clinical treatment for ankle weakness in children with spastic diplegia. A successful result
Interventions
- DRUG baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2005-01 |
| Est. Completion | 2006-04 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00255073
The ClinicalTrials.gov registry entry for NCT00255073 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which baclofen is the first listed.
NCT00255073 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00255073 about?
NCT00255073 is a clinical study titled "Does Reducing Spasticity Permit an Increase in Strength?". Reduction of spasticity has been a major focus of the treatment of childhood cerebral palsy, resulting in numerous treatment strategies that target various parts of the motor system. However, in many children weakness may be a greater contributor to disability than spasticity. Recent results suggest...
What is the current status of trial NCT00255073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2005-01. Estimated completion is 2006-04.
What interventions are being tested in trial NCT00255073?
The interventions under investigation include: baclofen (DRUG).
Who is sponsoring clinical trial NCT00255073?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.