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

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03930836
• Other study ID #: B403201316810c
• Status: Completed
• Phase: N/A
• Start date: June 14, 2018
• Est. completion date: July 15, 2020

Study information

• Verified date: December 2020
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 15, 2020
• Est. primary completion date: June 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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
• 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

Locations

Country	Name	City	State
Belgium	Institute of Neuroscience, Université catholique de Louvain	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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