Back to resultsA Multisite Trial of ACQUIREc Therapy
Primary Purpose
Hemiparetic Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapy services (ACQUIREc Therapy)
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparetic Cerebral Palsy focused on measuring Pediatric CI Therapy, ACQUIREc Therapy, Dosage, Occupational Therapy, Physical Therapy, Cerebral Palsy, Hemiparesis
Eligibility Criteria
Inclusion Criteria:
- Children 3-6 years of age
- Hemiparetic CP
Exclusion Criteria:
- No prior CI therapy treatments
- No Botox for 6-months
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment dosage levels examined
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00991692
First Posted
October 7, 2009
Last Updated
October 7, 2009
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT00991692
Brief Title
A Multisite Trial of ACQUIREc Therapy
Official Title
A Multisite Trial of ACQUIREc Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparetic Cerebral Palsy
Keywords
Pediatric CI Therapy, ACQUIREc Therapy, Dosage, Occupational Therapy, Physical Therapy, Cerebral Palsy, Hemiparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment dosage levels examined
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Therapy services (ACQUIREc Therapy)
Other Intervention Name(s)
Occupational Therapy, Physical Therapy, Pediatric CI Therapy, ACQUIREc Therapy
Intervention Description
Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children 3-6 years of age
Hemiparetic CP
Exclusion Criteria:
No prior CI therapy treatments
No Botox for 6-months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie C DeLuca, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35124
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22699104
Citation
DeLuca SC, Case-Smith J, Stevenson R, Ramey SL. Constraint-induced movement therapy (CIMT) for young children with cerebral palsy: effects of therapeutic dosage. J Pediatr Rehabil Med. 2012;5(2):133-42. doi: 10.3233/PRM-2012-0206.
Results Reference
derived
Learn more about this trial
A Multisite Trial of ACQUIREc Therapy
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