Intensive Therapies in Children With Hemiplegia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Modified Constraint Induced Movement Therapy and Bimanual Intensive Therapy in Children With Hemiplegia. Comparative Study

Conditions
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Infantile Hemiplegia

Intervention / Treatment
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* Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low performance group 1<br>Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy | Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2<br>* The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses. the protocols were carried out at home through the family<br>|
| Experimental: low performance group 2<br>Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy | Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2<br>* The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses. the protocols were carried out at home through the family<br>|
| Experimental: moderate-high performance group1<br>Protocol 1 will be the intervention administered with 80 h modified constraint induced movement therapy and 20 h bimanual intensive therapy | Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2<br>* The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses. the protocols were carried out at home through the family<br>|
| Experimental: moderate-high performance group 2<br>Protocol 2 will be the intervention administered with 80h bimanual intensive therapy and 20h modified constraint induced movement therapy | Combination Product: intensive therapies(CIMT/BIT): protocol 1 or protocol 2<br>* The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses. the protocols were carried out at home through the family<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life ,change is being assessed | This measure will be assessed with the pedsQL questionnaire | 4 assessments will be carried out in the research in 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infantile hemiplegia, upper extremity, physical therapy