Back to resultsA Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy (mCIT)
Primary Purpose
Hemiparesis, Cerebral Palsy
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Modified Constraint-induced movement therapy
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring Rehabilitation, Children, Cerebral Palsy, Arm, Paresis
Eligibility Criteria
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)
Sites / Locations
Outcomes
Primary Outcome Measures
Arm Use Test
Secondary Outcome Measures
Arm Function Test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00473447
Brief Title
A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy
Acronym
mCIT
Official Title
Phase1 Effectiveness of a Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy: a Cross-Over Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universita di Verona
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Cerebral Palsy
Keywords
Rehabilitation, Children, Cerebral Palsy, Arm, Paresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Modified Constraint-induced movement therapy
Primary Outcome Measure Information:
Title
Arm Use Test
Time Frame
Four months for each patient
Secondary Outcome Measure Information:
Title
Arm Function Test
Time Frame
Four months for each patient
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Fiaschi, MD PhD
Organizational Affiliation
Department of Neurological and Vision Sciences, University of Verona
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy
We'll reach out to this number within 24 hrs