Status:
COMPLETED
Acupuncture as Complementary Therapy for Cerebral Palsy
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Beijing Children's Hospital
Conditions:
Cerebral Palsy
Eligibility:
All Genders
12-72 years
Phase:
PHASE2
Brief Summary
Background: Cerebral palsy (CP) is the most frequent cause of childhood disability in the US. Nevertheless, current standard of care for CP in the U.S. is to a large extent ineffective. The Chinese, o...
Detailed Description
The proposed study is a parallel, two-arm, prospective, evaluation-blind, randomized controlled clinical trial (RCT). It has been designed to examine the effectiveness of acupuncture when used as an a...
Eligibility Criteria
Inclusion
- Children between the ages of 12 and 72 months.
- Children with a diagnosis of spastic cerebral palsy (CP) or mixed type CP where spasticity is the dominant feature.
Exclusion
- Age - Any child with CP who is younger than 12 months or older than 72 months.
- Etiology - Any damage to the CNS that either (a) is not static in nature, such as degenerative or progressive central nervous disorders, or (b) occurred after the first year of life, or (c) any child who has a phenotypic pattern suggesting a chromosomal abnormality (e.g., trisomy 13 or 18).
- Diagnosis - Children for whom the diagnosis of spastic CP or mixed-type CP with spasticity as the dominant feature cannot be established with absolute certainty, or children with dyskinetic CP. Rationale - To assure subject homogeneity, in cases in which there is disagreement between the physicians with respect to the diagnosis of a child, even if one of the physicians feels certain that a child has spastic CP, the children would be automatically excluded.
- Co-morbidities - Medical conditions, whether acute or chronic, for which acupuncture or intense 'conventional' therapies are considered contraindicated. Rationale - assuring participants' safety.
- Co-interventions - Any child receiving or scheduled to receive treatment(s) during the study period that may confound the results (e.g., an orthopedic or neurosurgical procedure, Botulinum toxin injections, a Baclofen pump or hyperbaric oxygen treatment). Rationale -To avoid a threat to causal inferences.
- Parallel participation in another CP clinical trial. Rationale - To avoid pragmatic and ethical issues that may arise as a result of a conflict of interests and limited resources.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00221247
Start Date
October 1 2004
End Date
October 1 2008
Last Update
May 16 2016
Active Locations (2)
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1
The University of Arizona, Department of Pediatrics
Tucson, Arizona, United States, 85724
2
Beijing Children's Hospital
Beijing, Beijing Municipality, China, 100045