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

Sponsor
Université Catholique de Louvain (Other)
Overall Status
Completed
CT.gov ID
NCT03930836
Collaborator
(none)
64
1
2
25
2.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities
  • Behavioral: Conventional physical and occupational therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Jun 14, 2018
Actual Primary Completion Date :
Jun 20, 2020
Actual Study Completion Date :
Jul 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: control group

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

Behavioral: Hand 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

Behavioral: Conventional 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

Experimental: interface group

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

Behavioral: Hand 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

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. 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

Secondary Outcome Measures

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 18 Years
Sexes Eligible for Study:
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institute of Neuroscience, Université catholique de Louvain Brussels Belgium 1200

Sponsors and Collaborators

  • Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yannick Bleyenheuft, Professor, Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT03930836
Other Study ID Numbers:
  • B403201316810c
First Posted:
Apr 29, 2019
Last Update Posted:
Dec 21, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yannick Bleyenheuft, Professor, Université Catholique de Louvain
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2020