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Completed

NCT Number: NCT03930836

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Neuroscience, Université catholique de Louvain

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand Arm Bimanual Intensive Therapy Including Lower Extremities

Behavioral

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 therapy

Behavioral

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

Primary outcomes

  1. Change from baseline Assisting Hand Assessments score at 1 week post-camp

    Time frame: 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).

  2. Change from baseline 6 Minutes Walking Test score at 1 week post-camp

    Time frame: 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

Secondary outcomes

  1. Change from baseline Box and Blocks test score at 1 week post-camp

    Time frame: 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

  2. Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp

    Time frame: 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.

  3. Change from baseline Modified Cooper test at 1 week post-camp

    Time frame: 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

  4. Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp

    Time frame: 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.

  5. Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp

    Time frame: 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.

  6. Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp

    Time frame: 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.

  7. Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp

    Time frame: 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

  8. Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp

    Time frame: 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.

  9. Change from baseline MHAVIE-child questionnaire score at 1 week post-camp

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

    Questionnaire measuring social participation

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2019
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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