- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00473447
A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy (mCIT)
May 14, 2007 updated by: Universita di Verona
Phase1 Effectiveness of a Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy: a Cross-Over Study
The purpose of this study is to determine if a modified protocol of constraint-induced movement therapy (CIT) is effective in rehabilitation treatment of arm paresis in children with cerebral palsy.
In these children one main problem the non-use of the affected arm.
Many studies showed that the non-use phenomenon can by reversed by the CIT, a rehabilitation program consisting of 15 days of restraining the unaffected arm plus a daily intensive (6 hours/day) physiotherapy training of the paretic arm.
The present study aims at evaluating if a shortened CIT protocol (restraining device plus only 2 weekly hours of physiotherapy) is effective in improving use and function of children paretic arm
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- presence of mild-moderate arm paresis (after cerebral palsy) enabling to
- reach and grasp a pellet
- age between 1-10 years
- active participation during proposed activities
- parents consent for participation -
Exclusion Criteria:
- presence of severe behaviour disturbances
- presence of severe mental retardation (QI<60)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arm Use Test
Time Frame: Four months for each patient
|
Four months for each patient
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Arm Function Test
Time Frame: Four months for each patient
|
Four months for each patient
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Antonio Fiaschi, MD PhD, Department of Neurological and Vision Sciences, University of Verona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
May 14, 2007
First Submitted That Met QC Criteria
May 14, 2007
First Posted (Estimate)
May 15, 2007
Study Record Updates
Last Update Posted (Estimate)
May 15, 2007
Last Update Submitted That Met QC Criteria
May 14, 2007
Last Verified
May 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 800
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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