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CompletedNCT03930836Updated Dec 21, 2020

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

An interventional study of Hand Arm Bimanual Intensive Therapy Including Lower Extremities and Conventional physical and occupational therapy in Cerebral Palsy, sponsored by Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-12-21.

Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Cerebral Palsy

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Keywords

  • motor function
  • motor skill learning
03

In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 64 is above the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 144 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosis of unilateral cerebral palsy
  • MACS level I, II or III
  • GMFCS level I, II, III

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Active comparator
    control group

    high/low dosage intervention, intensive or not (motor function rehabilitation)

    Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities · Behavioral: Conventional physical and occupational therapy

  • Experimental
    interface group

    high/low dosage intensive intervention using the interactive interface (motor function rehabilitation)

    Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities

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

  • BehavioralConventional physical and occupational therapy

    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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. 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

  3. 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

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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

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

  8. 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.

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

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

    Questionnaire measuring social participation

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

07

Study locations

1 site
  • Institute of Neuroscience, Université catholique de Louvain
    Brussels, 1200, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03930836
Lead sponsor
Université Catholique de Louvain
Responsible party
Yannick Bleyenheuft (Professor, Université Catholique de Louvain) — Principal investigator
First posted
Apr 29, 2019
Start date
Jun 14, 2018
Primary completion
Jun 20, 2020
Completion
Jul 15, 2020
Last update
Dec 21, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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