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Does Reducing Spasticity Permit an Increase in Strength?

NCT00255073 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2014-05-23

No results posted yet for this 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 will have immediate and significant implications for treatment of children with cerebral palsy.

Conditions

  • Spastic Diplegic Cerebral Palsy

Interventions

DRUG

baclofen

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Terence Sanger, md,phd · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2005-01-31
Completion
2006-04-30

Countries

  • United States

Study Locations

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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 NCT00255073 on ClinicalTrials.gov