Clinical Trial: Acupuncture as Complementary Therapy for Cerebral Palsy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Acupuncture as Complementary Therapy for Cerebral Palsy

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, 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

Detailed Summary:

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 childr
Sponsor: University of Arizona

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Arizona

Dates:
Date Received: September 13, 2005
Date Started: October 2004
Date Completion:
Last Updated: May 13, 2016
Last Verified: May 2016