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

Université Catholique de Louvain64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cerebral Palsy

Interventions

Hand Arm Bimanual Intensive Therapy Including Lower ExtremitiesBEHAVIORAL

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

Conventional physical and occupational therapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Neuroscience, Université catholique de Louvain

Brussels, Belgium

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

Secondary Outcomes

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

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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