A Multisite Trial of ACQUIREc Therapy

Hemiparetic Cerebral Palsy Clinical Trial

Official title:

A Multisite Trial of ACQUIREc Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00991692
• Other study ID #: deluca-ms1
• Status: Completed
• Phase: N/A
• First received: October 7, 2009
• Last updated: October 7, 2009
• Start date: June 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• Children 3-6 years of age

• Hemiparetic CP

Exclusion Criteria:

• No prior CI therapy treatments

• No Botox for 6-months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiparetic Cerebral Palsy

Intervention

Other:
• Therapy services (ACQUIREc Therapy)
Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States,