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

Sponsor:	Universita di Verona
Information provided by:	Universita di Verona
ClinicalTrials.gov Identifier:	NCT00473447

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 I

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:

MedlinePlus related topics: Cerebral Palsy Paralysis Rehabilitation

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 February 09, 2012