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A Multisite Trial of ACQUIREc Therapy

This study has been completed.
Sponsor:
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00991692
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Hemiparetic Cerebral Palsy
 Other: Therapy services (ACQUIREc Therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multisite Trial of ACQUIREc Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Enrollment: 18
Study Start Date: June 2008
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment dosage levels examined Other: Therapy services (ACQUIREc Therapy)
Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.
Other Names:
  • Occupational Therapy
  • Physical Therapy
  • Pediatric CI Therapy
  • ACQUIREc Therapy

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 3-6 years of age
  • Hemiparetic CP

Exclusion Criteria:

  • No prior CI therapy treatments
  • No Botox for 6-months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00991692

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35124
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Stephanie C DeLuca, PhD University of Alabama at Birmingham
  More Information

No publications provided by University of Alabama at Birmingham

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stephanie C. DeLuca, PhD, UAB
ClinicalTrials.gov Identifier: NCT00991692     History of Changes
Other Study ID Numbers: deluca-ms1
Study First Received: October 7, 2009
Last Updated: October 7, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Pediatric CI Therapy
ACQUIREc Therapy
Dosage
Occupational Therapy
 Physical Therapy
Cerebral Palsy
Hemiparesis

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013