Intensive Therapies in Children With Hemiplegia

Not Applicable

Completed

• Conditions: Infantile Hemiplegia

• Registration Number: NCT03465046
• Lead Sponsor: University of Salamanca

Brief Summary

This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.

Detailed Description

the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.

Study Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-13
• Study First Posted: 2018-03-14
• Study Start: 2018-10-15
• Primary Completion: 2018-11-25
• Study Completion: 2019-01-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.
• Ages between 5 to 10 years.
• Levels of I-III within the , manual ability classification system, MACS.
• Levels of I-III within the gross motor function classification system, GMFCS

Exclusion Criteria

• Diseases not associated with infantile hemiparesis.

• Low cognitive level to understand the execution of activities.
• Surgeries of the upper extremity during the 6 months prior to the intervention.
• Structured contractures in the affected upper extremity that cause functional impotence.
• Botulinum toxin two months prior to the intervention and application of it during the treatment.
• Epilepsy not controlled pharmacologically

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
bimanual functional performance, "change" is being assessed	4 assessments will be carried out in the research in 10 weeks	use of the affected upper extremity of spontaneous character during bimanual activities. It is used the AHA assessment to measure it.

Secondary Outcome Measures

Name	Time	Method
quality of life ,"change" is being assessed	4 assessments will be carried out in the research in 10 weeks	This measure will be assessed with the pedsQL questionnaire

Trial Locations

Locations (1)

Rocío Palomo Carrión; 🇪🇸 Torrijos, Toledo, Spain