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出境医 / 临床实验 / Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation

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

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
Cerebral Palsy Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities Behavioral: Conventional physical and occupational therapy Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 14, 2018
Actual Primary Completion Date : June 20, 2020
Actual Study Completion Date : July 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 [ 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
Layout table for eligibility information
Ages Eligible for Study:   5 Years 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

Locations
Layout table for location information
Belgium
Institute of Neuroscience, Université catholique de Louvain
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain
Tracking Information
First Submitted Date  ICMJE June 21, 2018
First Posted Date  ICMJE April 29, 2019
Last Update Posted Date December 21, 2020
Actual Study Start Date  ICMJE June 14, 2018
Actual Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • 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).
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2019)
  • 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
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: control group
    high/low dosage intervention, intensive or not (motor function rehabilitation)
    Interventions:
    • 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)
    Intervention: Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2019)
64
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 15, 2020
Actual Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03930836
Other Study ID Numbers  ICMJE B403201316810c
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yannick Bleyenheuft, Université Catholique de Louvain
Study Sponsor  ICMJE Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Université Catholique de Louvain
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP