A Modified Constraint-Induced Movement Therapy Program in Rehabilitation of Arm Paresis in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00473447
• Other study ID #: 800
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2007
• Last updated: May 14, 2007
• Start date: January 2004
• Est. completion date: April 2006

Study information

• Verified date: May 2007
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 10 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiparesis
• Paresis

Intervention

Behavioral:
• Modified Constraint-induced movement therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm Use Test		Four months for each patient
Secondary	Arm Function Test		Four months for each patient