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NCT00221247 · ClinicalTrials.gov registry record · Phase 2
Acupuncture as Complementary Therapy for Cerebral Palsy
A Phase 2 study of Cerebral Palsy, sponsored by University of Arizona.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
- 2
- Study locations
NCT00221247 is a Phase 2 study of Cerebral Palsy that has completed, run by University of Arizona. The registered enrollment target is 75 participants, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (67% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT00221247, a Phase 2 study of Cerebral Palsy, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
- 2
- Study locations
Study 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
Conditions Studied
Interventions
- PROCEDURE Acupuncture
Study Locations (2)
Arizona
- The University of Arizona, Department of Pediatrics - Tucson
Beijing Municipality
- Beijing Children's Hospital - Beijing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2004-10 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00221247
The ClinicalTrials.gov registry entry for NCT00221247 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 229-participant average among 91 other Cerebral Palsy trials with a reported enrollment target (67% lower). The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cerebral Palsy appearing as the primary indexed condition, and to 1 intervention - of which Acupuncture is the first listed.
NCT00221247 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Beijing Municipality.
Frequently Asked Questions
What is clinical trial NCT00221247 about?
NCT00221247 is a clinical study titled "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 in...
What is the current status of trial NCT00221247?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2004-10. Estimated completion is 2008-10.
What conditions does trial NCT00221247 study?
This clinical trial studies the following conditions: Cerebral Palsy.
What interventions are being tested in trial NCT00221247?
The interventions under investigation include: Acupuncture (PROCEDURE).
Who is sponsoring clinical trial NCT00221247?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00221247 being conducted?
This trial has 2 study locations across Arizona, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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