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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Hand Arm Bimanual Intensive Therapy Including Lower Extremities
Conventional physical and occupational therapy
Sponsored by
Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring motor function, motor skill learning

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Neuroscience, Université catholique de Louvain

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group

interface group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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

Secondary Outcome Measures

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
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.
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
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.
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.
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.
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
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.
Change from baseline MHAVIE-child questionnaire score at 1 week post-camp
Questionnaire measuring social participation

Full Information

First Posted
June 21, 2018
Last Updated
December 18, 2020
Sponsor
Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03930836
Brief Title
Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
July 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
motor function, motor skill learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Active Comparator
Arm Description
high/low dosage intervention, intensive or not (motor function rehabilitation)
Arm Title
interface group
Arm Type
Experimental
Arm Description
high/low dosage intensive intervention using the interactive interface (motor function rehabilitation)
Intervention Type
Behavioral
Intervention Name(s)
Hand Arm Bimanual Intensive Therapy Including Lower Extremities
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Conventional physical and occupational therapy
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline Assisting Hand Assessments score at 1 week post-camp
Description
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
Title
Change from baseline 6 Minutes Walking Test score at 1 week post-camp
Description
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 Outcome Measure Information:
Title
Change from baseline Box and Blocks test score at 1 week post-camp
Description
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
Title
Change from baseline Jebsen-Taylor Test of Hand Function score at 1 week post-camp
Description
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
Title
Change from baseline Modified Cooper test at 1 week post-camp
Description
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
Title
Change from baseline ABILHAND-Kids questionnaire score at 1 week post-camp
Description
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
Title
Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp
Description
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
Title
Change from baseline ABILOCO-Kids questionnaire at 1 week post-camp
Description
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
Title
Change from baseline Pediatric Evaluation of Disability Inventory score at 1 week post-camp
Description
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
Title
Change from baseline Canadian Occupational Performance Measure scores at 1 week post-camp
Description
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
Title
Change from baseline MHAVIE-child questionnaire score at 1 week post-camp
Description
Questionnaire measuring social participation
Time Frame
pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Institute of Neuroscience, Université catholique de Louvain
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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