Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation

Study Overview
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Brief Summary
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Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions. Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.

Official Title
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Implementation of a New Interactive Interface Applying Motor Skill Learning Principles to Generate Motor, Functional and Neuroplastic Changes During High and Low Dosage Interventions in Children With Cerebral Palsy

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities
* Behavioral: Conventional physical and occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of unilateral cerebral palsy MACS level I, II or III GMFCS level I, II, III Exclusion Criteria: unstable seizure cognitive deficit that prevent understanding of simple games botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration of 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>high/low dosage intervention, intensive or not (motor function rehabilitation) | Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities<br>* Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities. 50% of therapeutic time will be performed using the new interactive interface<br>Behavioral: Conventional physical and occupational therapy<br>* Conventional therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles. 50% of therapeutic time will be performed using the new interactive interface<br>|
| Experimental: interface group<br>high/low dosage intensive intervention using the interactive interface (motor function rehabilitation) | Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities<br>* Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities. 50% of therapeutic time will be performed using the new interactive interface<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Assisting Hand Assessments score at 1 week post-camp | The Assisting Hand Assessment has been developped to measure and describe the efficacy of use of the affected hand of children with unilateral cerebral palsy bimanual activity performance. This is a standardized criterion-referenced test. It is conducted as a recorded semi-structured play session using specific objects usually used in a bimanual manner. With twenty-two test items, the child's performance is measured and obtain a sum score measure and a scaled score (percent scale). | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Change from baseline 6 Minutes Walking Test score at 1 week post-camp | Measurement developped to assess the exercise tolerance and walking abilities by asking the patient to walk as much as possible during 6 minutes in a 30 meters long corridor | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Box and Blocks test score at 1 week post-camp | Test measuring hand function through the number of blocks transported in 1 minute from one part an other of a box placed in front of the child. Each hand tested separately | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp | Measure of hand function/dexterity, through 7 activities simulating daily life activities. Each hand is tested separately and time to complete each activity is reported using a stopwatch. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Change from baseline Modified Cooper test at 1 week post-camp | Measurement of the stereognosis abilities.16 objects are placed in the hand and the child has to recognise the object only by touch. both hands are tested separately and time to recognise the objects is reported using a stopwatch | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp | questionnaire measuring performance of the child in daily life activities focusing on the upper extremities. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp | questionnaire measuring performance of the child in daily life activities focusing on upper and lower extremities. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp | questionnaire measuring performance of the child in daily life activities focusing on the lower extremities. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp | questionnaire measuring performance of the child in daily life activities focusing on the upper extremities and lower extremities. Only the self-care domain will be assessed here | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp | The Canadian Occupational Performance Measure is a measure designed to capture the patient's self-perception of performance in everyday living, over time. It consist of a semi-structured interview were the patient elicits daily life activities performed with difficulties (self-care, nutrition, transfer, household management, school, work, transport, leisure, etc). Five activities are then chosen as the most important to improve and score on a 1 to 10 scale based on the actual patient's performance and satisfaction levels. | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 
| Change from baseline MHAVIE-child questionnaire score at 1 week post-camp | Questionnaire measuring social participation | pre-camp (1 week before), post-camp (1 week after), 3 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor function, motor skill learning