Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
1997-07-31
Brief Summary
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Detailed Description
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Forty children, ages 4 to 12 years, will be recruited and randomized into one of two groups. Group A will receive BTX. Group B will receive a placebo injection. Participants will be assessed at the beginning of the trial and at Weeks 3, 8, 12, and 24. Assessments include quantitative electromyographic kinesiology measurements, electromechanical measurement of joint torque across the ankle joint using the Spasticity Measurement System, Gross Motor Function Measure, physical exam parameters, energy expenditure using the Energy Cost Index, kinematic gait analysis, and the Canadian Occupational Performance Measure.
Participants are followed for a total of 6 months. Participants initially randomized to Group B will have the opportunity for BTX treatment after 24 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Botulinum toxin type A
Eligibility Criteria
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Inclusion Criteria
* Community or independent ambulators
* Expressive communication skills at age 3 or above
* Stable social environment
* Reasonable proximity to the medical center
* Physical therapy at least once per week
* No other serious health problems that would interfere with the study
Exclusion Criteria
* Previous treatment with botulinum toxin
* Musculoskeletal contractures greater than 15 degrees
* Unstable social environment
3 Years
12 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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Ross M. Hays, M.D.
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital and Regional Medical Center
Locations
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Children's Hospital and Regional Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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