Effect of HABIT-ILE on Visuo-spatial Attention of Children With Unilateral CP

Study Overview
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Brief Summary
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This study aims to investigate the changes induced by HABIT-ILE in impairments, activity and participation of children with unilateral CP, as well as neuroplastic changes induced by the treatment. Visuospatial deficits will be investigated and the effect of prismatic adaptation will be measured.

Detailed Description
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This study aims to investigate the changes induced by HABIT-ILE at the 3 levels of the international classification of functioning and health (ICF) in children with unilateral CP, as well as neuroplastic changes induced by the treatment. Visuospatial deficits will be investigated and the effect of prismatic adaptation will be measured.

Official Title
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Effect of Rehabilitation in Deficiencies, Activities Limitations and Restrictions of the Participation of the Children Presenting Neurological Lesions. Impact of Contextual Factors on the Functioning of These Patients. Part II

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Behavioral: HABIT-ILE with prismatic adaptation
* Behavioral: HABIT-ILE without prismatic adaptation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral CP minimal ability to pick an light object from a table age 5-18 Exclusion Criteria: no active seizure no botox or orthopedic intervention in the 6 months preceding the study or during the study

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prismatic adaptation<br>Including 8 hours of therapy with prismatic adaptation wearing prismatic goggles during bimanual intensive and locomotor intensive intervention (HABIT-ILE). | Behavioral: HABIT-ILE with prismatic adaptation<br>* Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation<br>|
| Active Comparator: sham goggles<br>Including 8 hours of therapy wearing sham goggles during bimanual intensive and locomotor intensive intervention (HABIT-ILE). | Behavioral: HABIT-ILE without prismatic adaptation<br>* Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in star cancellation | number of little stars omitted in a frame including many stars of different size | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| change in Ogden Figure test | number of elements omitted when reproducing a drawing | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| changes in line bissection | deviation from midline during line section | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| visuo-spatial pointing | pointing in a blind box in the direction of a visual cue, measuring the deviation from midline | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| proprioceptive pointing | pointing without any visual feedback in the direction of body midline and measuring deviation | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jebsen-Taylor test of hand function | Manual dexterity measured with objects of everyday life, measure=time to manipulate objects | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| functional magnetic resonance imaging (fMRI) | cortical activation (changes in voxels activation) | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| Box and blocks | number of blocks manipulated in one minute | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| Assisting Hand Assessment | help provided by the paretic hand to the non-paretic one in bimanual coordination | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| ABILHAND-Kids questionnaire | parents-reported questionnaire measuring manual ability | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| ACTIVLIM-CP questionnaire | parents-reported questionnaire measuring global activity performance | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| Canadian Occupationnal Performance Measure | setting therapeutic goals with parents and measuring both performance and satisfaction (%) | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 
| diffusion tensor imaging (DDTI) | measuring changes in white matter tracts (fractional anisotropy, number of voxels) | at baseline and after 90 hours/two weeks of intensive bimanual intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor skill learning, visuo-spatial attention