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Botulinum Toxin (BOTOX) for Cerebral Palsy Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Botulinum Toxin (BOTOX) for Cerebral Palsy conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Botulinum Toxin (BOTOX) for Cerebral Palsy Clinical research trials and Botulinum Toxin (BOTOX) for Cerebral Palsy healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Botulinum Toxin (BOTOX) for Cerebral Palsy. Botulinum Toxin (BOTOX) for Cerebral Palsy Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Botulinum Toxin (BOTOX) for Cerebral Palsy clinical trial. Participants typically obtain the most effective healthcare available for their Botulinum Toxin (BOTOX) for Cerebral Palsy condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Botulinum Toxin (BOTOX) for Cerebral Palsy  Botulinum Toxin (BOTOX) for Cerebral Palsy
Botulinum Toxin (BOTOX) for Cerebral Palsy
For Condition: Muscle Spasticity,Cerebral Palsy
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: This study examines botulinum toxin (BOTOX, or BTX) for the treatment of muscle twitches and spasticity associated with cerebral palsy in children. Botulinum toxin is a naturally occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.
Details: This trial will test the effectiveness of BTX injections versus placebo to reduce plantar-flexor spasticity and improve function and mobility in children with spastic diplegia, a common form of cerebral palsy. The study will evaluate the effects of the treatment across five domains that relate to disability: pathophysiology, impairment, functional limitation, disability, and societal limitation. 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.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 3 Years/12 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Spastic diplegic cerebral palsy - 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: - Other forms of cerebral palsy - Previous treatment with botulinum toxin - Musculoskeletal contractures greater than 15 degrees - Unstable social environment
Total Enrollment: 40
Location and Contact Information:
Overall Study Official:
RossHays, Principal Investigator, Children's Hospital and Regional Medical Center
Children's Hospital and Regional Medical Center *Recruiting*
Seattle, Washington, 98105
United States
Recruiting
Additional Information:
Study ID Numbers: 1R01HD35750-01;
Study Start Date: July 1997
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060957
Other Muscle Spasticity Studies:
1. Classification of Cerebral Palsy Subtypes
2. Constraint-based Therapy to Improve Motor Function in Children with Cerebral Palsy
3. Relaxation Training to Decrease Pain and Improve Function in Adolescents with Cerebral Palsy
4. Magnesium Sulfate to Prevent Brain Injury in Premature Infants
5. Beneficial Effects of Antenatal Magnesium Sulfate (BEAM Trial)
Related Studies:
Other Muscle Spasticity Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Botulinum Toxin (BOTOX) for Cerebral Palsy
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