NCT00991692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
Last Updated

October 8, 2009

Status Verified

October 1, 2009

Enrollment Period

1.2 years

First QC Date

October 7, 2009

Last Update Submit

October 7, 2009

Conditions

Hemiparetic Cerebral Palsy

Keywords

Pediatric CI TherapyACQUIREc TherapyDosageOccupational TherapyPhysical TherapyCerebral PalsyHemiparesis

Study Arms (1)

Treatment dosage levels examined

EXPERIMENTAL
Other: Therapy services (ACQUIREc Therapy)

Interventions

Therapy services (ACQUIREc Therapy)OTHER

Dosage levels that are associated with the efficacy of intensive therapeutic services provided by OT and PT professionals.

Also known as: Occupational Therapy, Physical Therapy, Pediatric CI Therapy, ACQUIREc Therapy
Treatment dosage levels examined

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children 3-6 years of age
  • Hemiparetic CP

You may not qualify if:

  • No prior CI therapy treatments
  • No Botox for 6-months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35124, United States

Location

Related Publications (1)

  • 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.

    PMID: 22699104DERIVED

MeSH Terms

Conditions

Cerebral PalsyParesis

Interventions

Occupational TherapyPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Stephanie C DeLuca, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

June 1, 2008

Primary Completion

August 1, 2009

Study Completion

October 1, 2009

Last Updated

October 8, 2009

Record last verified: 2009-10

Locations

US(1)