Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
- Conditions
- Cerebral Palsy
- Interventions
- Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower ExtremitiesBehavioral: Conventional physical and occupational therapy
- Registration Number
- NCT03930836
- Lead Sponsor
- Université Catholique de Louvain
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- diagnosis of unilateral cerebral palsy
- MACS level I, II or III
- GMFCS level I, II, III
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group Hand Arm Bimanual Intensive Therapy Including Lower Extremities high/low dosage intervention, intensive or not (motor function rehabilitation) control group Conventional physical and occupational therapy high/low dosage intervention, intensive or not (motor function rehabilitation) interface group Hand Arm Bimanual Intensive Therapy Including Lower Extremities high/low dosage intensive intervention using the interactive interface (motor function rehabilitation)
- Primary Outcome Measures
Name Time Method Change from baseline 6 Minutes Walking Test score at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up 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
Change from baseline Assisting Hand Assessments score at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up 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).
- Secondary Outcome Measures
Name Time Method Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up questionnaire measuring performance of the child in daily life activities focusing on upper and lower extremities.
Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up 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.
Change from baseline Modified Cooper test at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up 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
Change from baseline MHAVIE-child questionnaire score at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up Questionnaire measuring social participation
Change from baseline Box and Blocks test score at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up 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
Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up questionnaire measuring performance of the child in daily life activities focusing on the upper extremities.
Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up questionnaire measuring performance of the child in daily life activities focusing on the lower extremities.
Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up 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
Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp pre-camp (1 week before), post-camp (1 week after), 3 months follow-up 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.
Trial Locations
- Locations (1)
Institute of Neuroscience, Université catholique de Louvain
🇧🇪Brussels, Belgium