Upper Limb Intensive Therapies in Babies With Unilateral Cerebral Palsy.

Study Overview
=================
Brief Summary
-----------------
mCIMT and BIT are therapies applied in children with hemiplegia which have a great evidence, but not in a early age. This research has the objective to know the effects of this therapies in infants diagnosed of infantile hemiplegia from 9 to 18 months applying 50 hours of dose for both interventions during 10 weeks, executing them at home by familes.

Official Title
-----------------
Effects of Infant Constraint Induced Movement Therapy and Infant Bimanual Intensive Therapy in Unilateral Cerebral Palsy. A Randomized Controlled Trial.

Conditions
-----------------
Infantile Hemiplegia, Upper Extremity Paresis, Family, Constraint Induced Movement Therapy, Bimanual Intensive Therapy

Intervention / Treatment
-----------------
* Other: Infant BIT
* Other: Infant CIMT/BIT
* Other: Conventional therapy
* Other: infant cimt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infantile hemiplegia Age from 9 months to 18 months. No use of the affected upper limb Exclusion Criteria: Associated pathologies Epilepsy no controlled with medicins No collaborated families

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 18 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: infant cimt<br> | Other: Infant BIT<br>* Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination<br>Other: Infant CIMT/BIT<br>* Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.<br>Other: Conventional therapy<br>* Following the usual therapy in the baby.<br>|
| Active Comparator: Infant BIT<br> | Other: Infant CIMT/BIT<br>* Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.<br>Other: Conventional therapy<br>* Following the usual therapy in the baby.<br>Other: infant cimt<br>* use of unaffected hand containment to improve the use of affected hand with unimanual activities<br>|
| Active Comparator: Infant CIMT/BIT<br> | Other: Infant BIT<br>* Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination<br>Other: Conventional therapy<br>* Following the usual therapy in the baby.<br>Other: infant cimt<br>* use of unaffected hand containment to improve the use of affected hand with unimanual activities<br>|
| Active Comparator: Conventional Therapy<br> | Other: Infant BIT<br>* Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination<br>Other: Infant CIMT/BIT<br>* Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.<br>Other: infant cimt<br>* use of unaffected hand containment to improve the use of affected hand with unimanual activities<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mini Assisting Hand Assesment | Bimanual functional performance Assessment in children with hemiplegia from 8 to 18 months. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction questionnaire for familes | Descriptive questionnaire to obtain the adherence and satisfaction from families in this therapies. | 10 weeks |