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

NCT00473447 | Completed Phase 1

• 1 other identifier: 800
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Hemiparesis; Cerebral Palsy

Keywords

Rehabilitation; Children; Cerebral Palsy; Arm; Paresis

Outcome Measures

Primary Outcomes (1)

• Arm Use Test

  Four months for each patient

Secondary Outcomes (1)

• Arm Function Test

  Four months for each patient

Interventions

Modified Constraint-induced movement therapy BEHAVIORAL

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 -

You may not qualify if:

• presence of severe behaviour disturbances
• presence of severe mental retardation (QI\<60)

Sponsors & Collaborators

• Universita di Verona: lead

MeSH Terms

Conditions

Paresis; Cerebral Palsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Antonio Fiaschi, MD PhD

  Department of Neurological and Vision Sciences, University of Verona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 15, 2007
• Study Start: January 1, 2004
• Study Completion: April 1, 2006
• Last Updated: May 15, 2007

Record last verified: 2007-05