We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00473447
First Posted: May 15, 2007
Last Update Posted: May 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universita di Verona
  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
Intervention Model: Crossover Assignment
Masking: Single
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00473447     History of Changes
Other Study ID Numbers: 800
First Submitted: May 14, 2007
First Posted: May 15, 2007
Last Update Posted: May 15, 2007
Last Verified: May 2007

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

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Paresis
Muscle Weakness
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes