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

This study has been completed.
Sponsor:
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT00473447
First received: May 14, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hemiparesis
Cerebral Palsy
 Behavioral: Modified Constraint-induced movement therapy
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • Arm Use Test [ Time Frame: Four months for each patient ]

Secondary Outcome Measures:
  • Arm Function Test [ Time Frame: Four months for each patient ]

Enrollment: 10
Study Start Date: January 2004
Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00473447

Sponsors and Collaborators
Universita di Verona
Investigators
Study Director: Antonio Fiaschi, MD PhD Department of Neurological and Vision Sciences, University of Verona
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00473447     History of Changes
Other Study ID Numbers: 800
Study First Received: May 14, 2007
Last Updated: May 14, 2007
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by Universita di Verona:
Rehabilitation
Children
Cerebral Palsy
Arm
Paresis

Additional relevant MeSH terms:
Cerebral Palsy
Paresis
Paralysis
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013