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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014