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Clinical Trials/NCT03930836
NCT03930836
Completed
Not Applicable

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

Université Catholique de Louvain1 site in 1 country64 target enrollmentJune 14, 2018
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Université Catholique de Louvain
Enrollment
64
Locations
1
Primary Endpoint
Change from baseline 6 Minutes Walking Test score at 1 week post-camp
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 14, 2018
End Date
July 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yannick Bleyenheuft

Professor

Université Catholique de Louvain

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

Outcomes

Primary Outcomes

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

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).

Secondary Outcomes

  • Change from baseline ACTIVLIM-CP questionnaire score at 1 week post-camp(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(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(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(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)
  • Change from baseline Box and Blocks test score at 1 week post-camp(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(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(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(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(pre-camp (1 week before), post-camp (1 week after), 3 months follow-up)

Study Sites (1)

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