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

  • Clinicaltrials.gov identifier

    NCT03930836

  • Recruitment Status

    Completed

  • First Posted

    April 29, 2019

  • Last update posted

    December 21, 2020

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

Detailed Description

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: June 2018
  • Actual Primary Completion Date: June 2020
  • Actual Study Completion Date: July 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 [ 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 Outcome Measures: 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

Eligibility Criteria

  • Ages Eligible for Study: 5 to 18 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts

Locations

Belgium
Institute of Neuroscience, Université catholique de Louvain
Brussels

Sponsors and Collaborators

Université Catholique de Louvain

More Information

  • Responsible Party: Université Catholique de Louvain
  • ClinicalTrials.gov Identifier: NCT03930836 History of Changes
  • Other Study ID Numbers: B403201316810c
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: December 21, 2020
  • Last Verified: December 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • 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 Université Catholique de Louvain: motor function motor skill learning
  • Additional relevant MeSH terms: Cerebral Palsy