Cerebral Palsy Clinical Trial
Official title:
Acupuncture as Complementary Therapy for Cerebral Palsy
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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