Cerebral PalsyPhase 2NCT00221247
Acupuncture as Complementary Therapy for Cerebral Palsy
A Phase 2 study testing Acupuncture in people with Cerebral Palsy, run by University of Arizona at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 72 months
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2004to Oct 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 72 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
The University of Arizona, Department of Pediatrics
Tucson, Arizona, 85724
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Acupuncture
- Keywords
- cerebral palsy; acupuncture
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy with acupuncture Receives: Procedure: Acupuncture |
| Group 2 | No intervention | Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy without acupuncture |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionMar 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Children's Hospital
- Responsible party
- Principal investigator, Burris Duncan, University of Arizona
- Investigators
- Burris Duncan, M.D., Principal investigator, The University of Arizona, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221247
- Sponsor's protocol ID
- HSC #04-126
- Other IDs
- ADCRC: No. 9-039, Commission contract No.9001
- Status last verified
- May 2016
- First submitted
- 13 Sep 2005
- Last updated
- 16 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Duncan B, Shen K, Zou LP, Han TL, Lu ZL, Zheng H, Walsh M, Venker C, Su Y, Schnyer R, Caspi O. Evaluating intense rehabilitative therapies with and without acupuncture for children with cerebral palsy: a randomized controlled trial. Arch Phys Med Rehabil. 2012 May;93(5):808-15. doi: 10.1016/j.apmr.2011.12.009.
PubMed 22541308Wu Y, Zou LP, Han TL, Zheng H, Caspi O, Wong V, Su Y, Shen KL. Randomized controlled trial of traditional Chinese medicine (acupuncture and tuina) in cerebral palsy: part 1--any increase in seizure in integrated acupuncture and rehabilitation group versus rehabilitation group? J Altern Complement Med. 2008 Oct;14(8):1005-9. doi: 10.1089/acm.2007.0756.
PubMed 18990048
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as Complementary Therapy for Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00221247
- Acronym / sponsor ID
- HSC #04-126
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy; acupuncture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Beijing Children's Hospital
- Study start
- Oct 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: AcupunctureIntensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy with acupuncture |
| Group 2 | No intervention | –Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy without acupuncture |
Who may qualify
- Ages
- 12 to 72 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupunctureacupuncture | Procedure or surgery | Group 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2016.
- Derived from this study: PubMed 22541308Duncan B, Shen K, Zou LP, Han TL, Lu ZL, Zheng H, Walsh M, Venker C, Su Y, Schnyer R, Caspi O. Evaluating intense rehabilitative therapies with and without acupuncture for children with cerebral palsy: a randomized controlled trial. Arch Phys Med Rehabil. 2012 May;93(5):808-15. doi: 10.1016/j.apmr.2011.12.009.
- Derived from this study: PubMed 18990048Wu Y, Zou LP, Han TL, Zheng H, Caspi O, Wong V, Su Y, Shen KL. Randomized controlled trial of traditional Chinese medicine (acupuncture and tuina) in cerebral palsy: part 1--any increase in seizure in integrated acupuncture and rehabilitation group versus rehabilitation group? J Altern Complement Med. 2008 Oct;14(8):1005-9. doi: 10.1089/acm.2007.0756.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burris Duncan, M.D. principal investigator
The University of Arizona, Department of Pediatrics
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture in people with Cerebral Palsy, run by University of Arizona at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221247, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2016.