- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00991692
A Multisite Trial of ACQUIREc Therapy
October 7, 2009 updated by: University of Alabama at Birmingham
A multisite trial to testing different dosage levels of a systematic form of Pediatric Constraint-Induced (CI) Therapy called ACQUIREc Therapy.
The high dosage treatment involved 6 hours of daily therapy services for 21 days.
This was compared to a moderate dosage level of 3 hours of daily therapy services for 21 days.
It was hypothesized that children receiving the higher therapy dosage would have greater and more clinically significant benefits from ACQUIREc Therapy but that both groups of children would benefit from the therapy services.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35124
- University of Alabama at Birmingham
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 8 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children 3-6 years of age
- Hemiparetic CP
Exclusion Criteria:
- No prior CI therapy treatments
- No Botox for 6-months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment dosage levels examined
|
Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.
Other Names:
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephanie C DeLuca, PhD, University of Alabama at Birmingham
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (ACTUAL)
August 1, 2009
Study Completion (ACTUAL)
October 1, 2009
Study Registration Dates
First Submitted
October 7, 2009
First Submitted That Met QC Criteria
October 7, 2009
First Posted (ESTIMATE)
October 8, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 8, 2009
Last Update Submitted That Met QC Criteria
October 7, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- deluca-ms1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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