Trial record 7 of 126 for:    Open Studies | "Cerebral Palsy"

Acupuncture as Complementary Therapy for Cerebral Palsy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by University of Arizona.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Beijing Children's Hospital
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00221247
First received: September 13, 2005
Last updated: October 4, 2007
Last verified: October 2007
  Purpose

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, on the other hand, claim to have an exceptionally high response rate with the administration of an integrated package of care that includes the combination of intense 'conventional' therapies and acupuncture. Despite numerous anecdotal reports, this claim has not yet been tested in a rigorous scientific way. Objective: To determine the effectiveness of acupuncture when used as an adjunct to intense 'conventional' physical, occupational, and hydro- therapies to improve function and quality of life in children with spastic CP. Hypotheses: (1) Adjunctive acupuncture therapy will improve the gross and fine motor function and the health related quality of life of children with spastic CP more than intense 'conventional' therapies alone. (2) The level of persistence of gross and fine motor function and health related quality of life achieved with adjunctive acupuncture administered in combination with intense 'conventional' therapies will be higher than those achieved with intense 'conventional' therapies alone. Design: A parallel, two-arm, prospective, evaluation-blind, pragmatic, non-inferiority, randomized controlled clinical trial (RCT). Setting: This international collaborative study will be conducted at two different localities: (1) At the Beijing Children's Hospital (BCH), where participants' recruitment, intervention therapies, videotape evaluation, and data collection will be done, and (2) At the University of Arizona, where scoring of the videotape evaluations and data analyses will be done, and from where logistic support will be provided to assure the scientific integrity of the study. Population: Approximately 100 children between the ages 1 and 6 years with spastic CP. Intervention: Concurrent administration of acupuncture with intense 'conventional' therapies at the outset of the study vs. sequential administration of both components. Outcomes: 'Gross Motor Function', 'Fine Motor Function', 'Range of Motion', 'Level of Motor Involvement', and 'Health-Related Quality of Life' measured at times 0,4,8,12,24,and 36 weeks. Evaluation: Independent blinded evaluation with respect to the type of the intervention and the stage of the therapeutic schedule done in the U.S. based on videotapes filmed in China. Data management: Web-based data center and intersite-networking infrastructure. Data analyses: Intention to treat analysis supplemented by linear mixed effects models with nested grouping factors. Significance and future directions: If the hypotheses are confirmed the study would lay the groundwork for future research, and impact clinical practice and health care policy as related to CP therapy.


Condition Intervention Phase
Cerebral Palsy
Procedure: Acupuncture; deep massage; physical therapy; occupational therapy; and hydrotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Acupuncture as Complementary Therapy for Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Estimated Enrollment: 100
Study Start Date: October 2004
Estimated Study Completion Date: July 2007
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 adjunct to intense 'conventional' physical, occupational, and hydro- therapies to improve function and quality of life in children with spastic cerebral palsy (CP). This international collaborative study will be conducted at two locations: (1) At the Beijing Children's Hospital (BCH), where participants' recruitment, intervention therapies, videotape evaluation, and data collection will be done, and (2) At the University of Arizona, where scoring of the videotape evaluations and data analyses will be done, and from where logistic support will be provided to assure the scientific integrity of the study. The specific aims of the proposed study are:

Specific Aim #1: To compare the outcomes achieved after 12 weeks of acupuncture administered concurrently with intense 'conventional' therapies (physical, occupational, and hydro-therapies) to those achieved with intense 'conventional' therapies alone in the management of children with spastic CP.

Hypothesis #1: Adjunctive acupuncture administered concurrently with intense 'conventional' therapies will improve the gross and fine motor function and the health related quality of life of children with spastic CP more than intense 'conventional' therapies alone, as determined by standardized measures (see pgs. 20-22).

Specific Aim #2: To examine the short and intermediate term persistence of any changes in the outcomes achieved with acupuncture administered concurrently with intense 'conventional' therapies (physical, occupational, and hydro-therapies) to those achieved with intense 'conventional' therapies alone in the management of children with spastic CP.

Hypothesis #2: When compared three months after termination of therapy, the level of gross and fine motor function and health related quality of life achieved with acupuncture administered concurrently with intense 'conventional' therapies (physical, occupational, and hydro-therapies) will be higher than those achieved with intense 'conventional' therapies alone.

Taking advantage of the fact that ethically all the Chinese children with spastic CP who would participate in this study ought to receive acupuncture at one point or another as part of their care (see pg. 12) we propose, as a secondary aim, to begin to examine whether the timing of the administration of adjunctive acupuncture in relation to the timing of the administration of intense 'conventional' therapies has any effect on the outcomes, as determined by standardized measures.

It is to be emphasized, that this study does not aim primarily at testing sequence effects related to the most appropriate timing of administration of adjunctive acupuncture in the treatment of children with spastic CP since a) it must first be examined whether acupuncture has any effect at all in this population, and b) testing sequence effects would greatly complicate the design of such a study to a point where it may render it not feasible. Rather, we are simply taking advantage of the ethical obligation to provide every participant with acupuncture at some point in time (not because it is proven from an efficacy standpoint but because it is the standard of care in China) so as to begin to explore any potential temporal relationships between administration of adjunctive acupuncture and outcomes. For example, since Group 1 would receive adjunctive acupuncture concurrently with intense 'conventional' therapies whereas Group 2 would receive adjunctive acupuncture therapy subsequently to intense 'conventional' therapies (see Figure 1 on pg. 11), the design allows to begin to explore whether adjunctive acupuncture administered subsequent to intense 'conventional' therapies may have a booster effect on the degree of gross and fine motor function and health related quality of life of children with spastic CP.

  Eligibility

Ages Eligible for Study:   12 Months to 72 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221247

Contacts
Contact: Burris Duncan, M.D. 520-626-6862 bduncan@peds.arizona.edu
Contact: Opher Caspi, M.D. Ph.D. Ocaspi@clalit.org.il

Locations
United States, Arizona
The University of Arizona, Department of Pediatrics Recruiting
Tucson, Arizona, United States, 85724
Contact: Burris Duncan, M.D.    520-626-6862    bduncan@peds.arizona.edu   
Contact: Yani Su, MPH    520-304-3677    yani@email.arizona.edu   
Principal Investigator: Burris Duncan, M.D.         
China, Beijing
Beijing Children's Hospital Recruiting
Beijing, Beijing, China, 100045
Contact: Tongli Han, M.D.    011-86-10-68053223    hantongli@sohu.com   
Sub-Investigator: Liping Zou, M.D.         
Sponsors and Collaborators
University of Arizona
Beijing Children's Hospital
Investigators
Principal Investigator: Burris Duncan, M.D. The University of Arizona, Department of Pediatrics
  More Information

No publications provided by University of Arizona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00221247     History of Changes
Other Study ID Numbers: HSC #04-126, ADCRC: No. 9-039, Commission contract No.9001
Study First Received: September 13, 2005
Last Updated: October 4, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
cerebral palsy; acupuncture

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014