Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00221247
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2005-09-13
Brief Title:
Acupuncture as Complementary Therapy for Cerebral Palsy
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
Acupuncture as Complementary Therapy for Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 Childrens 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 0481224and 36 weeks Evaluation Independent blinded evaluation with respect to the type of the intervention and the stage of the therapeutic schedule done in the US 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
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 Childrens 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Commission contract No9001 | OTHER | Commission | None |
| ADCRC No 9-039 | OTHER_GRANT | None | None |