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A Multisite Trial of ACQUIREc Therapy

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT00991692
Collaborator
(none)
18
Enrollment
1
Location
1
Arm
16
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Therapy services (ACQUIREc Therapy)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multisite Trial of ACQUIREc Therapy
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
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

    		•

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      3 Years to 8 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 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

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00991692
      Other Study ID Numbers:
      • deluca-ms1
      First Posted:
      Oct 8, 2009
      Last Update Posted:
      Oct 8, 2009
      Last Verified:
      Oct 1, 2009
      Keywords provided by , ,
      Pediatric CI Therapy
      ACQUIREc Therapy
      Dosage
      Occupational Therapy
      Physical Therapy
      Cerebral Palsy
      Hemiparesis
      Additional relevant MeSH terms:
      Cerebral Palsy

      Study Results

      No Results Posted as of Oct 8, 2009