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

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 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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities; Behavioral: Conventional physical and occupational therapy

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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.	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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.	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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.	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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.	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
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.	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up
Change from baseline MHAVIE-child questionnaire score at 1 week post-camp	Questionnaire measuring social participation	pre-camp (1 week before), post-camp (1 week after), 3 months follow-up

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Actual): June 20, 2020
• Study Completion (Actual): July 15, 2020

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: motor function; motor skill learning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: B403201316810c

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No