Acupuncture as Complementary Therapy for Cerebral Palsy
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00221247 |
|
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : May 16, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cerebral Palsy | Procedure: Acupuncture | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Acupuncture as Complementary Therapy for Cerebral Palsy |
| Study Start Date : | October 2004 |
| Actual Primary Completion Date : | March 2008 |
| Actual Study Completion Date : | October 2008 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Group 1
Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy with acupuncture
|
Procedure: Acupuncture
acupuncture |
|
No Intervention: Group 2
Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy without acupuncture
|
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 12 Months to 72 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221247
| United States, Arizona | |
| The University of Arizona, Department of Pediatrics | |
| Tucson, Arizona, United States, 85724 | |
| China, Beijing | |
| Beijing Children's Hospital | |
| Beijing, Beijing, China, 100045 | |
| Principal Investigator: | Burris Duncan, M.D. | The University of Arizona, Department of Pediatrics |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Burris Duncan, Professor of Pediatrics & Public Health, University of Arizona |
| ClinicalTrials.gov Identifier: | NCT00221247 History of Changes |
| Other Study ID Numbers: |
HSC #04-126 ADCRC: No. 9-039 ( Other Grant/Funding Number: ADCRC ) Commission contract No.9001 ( Other Identifier: Commission ) |
| First Posted: | September 22, 2005 Key Record Dates |
| Last Update Posted: | May 16, 2016 |
| Last Verified: | May 2016 |
Keywords provided by Burris Duncan, University of Arizona:
|
cerebral palsy; acupuncture |
Additional relevant MeSH terms:
|
Paralysis Cerebral Palsy Neurologic Manifestations Nervous System Diseases |
Signs and Symptoms Brain Damage, Chronic Brain Diseases Central Nervous System Diseases |