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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03930836
Enrollment
64
Registered
2019-04-29
Start date
2018-06-14
Completion date
2020-07-15
Last updated
2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

motor function, motor skill learning

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.

Interventions

BEHAVIORALHand Arm Bimanual Intensive Therapy Including Lower Extremities

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 therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles. 50% of therapeutic time will be performed using the new interactive interface

Sponsors

Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline Assisting Hand Assessments score at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upThe 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).
Change from baseline 6 Minutes Walking Test score at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upMeasurement 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

Secondary

MeasureTime frameDescription
Change from baseline Modified Cooper test at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upMeasurement 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 ABILHAND-Kids questionnaire score at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upquestionnaire measuring performance of the child in daily life activities focusing on the upper extremities.
Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upquestionnaire measuring performance of the child in daily life activities focusing on upper and lower extremities.
Change from baseline Box and Blocks test score at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upTest 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 Pediatric Evaluation of Disability Inventory score at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upquestionnaire 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-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upThe 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.
Change from baseline MHAVIE-child questionnaire score at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upQuestionnaire measuring social participation
Change from baseline ABILOCO-Kids questionnaire at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upquestionnaire measuring performance of the child in daily life activities focusing on the lower extremities.
Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camppre-camp (1 week before), post-camp (1 week after), 3 months follow-upMeasure 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026