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

NCT ID: NCT03930836

Last Updated: 2020-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-14

Study Completion Date

2020-07-15

Brief Summary

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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

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Conditions

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Cerebral Palsy

Keywords

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motor function motor skill learning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

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

Group Type ACTIVE_COMPARATOR

Hand Arm Bimanual Intensive Therapy Including Lower Extremities

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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

interface group

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

Group Type EXPERIMENTAL

Hand Arm Bimanual Intensive Therapy Including Lower Extremities

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Yannick Bleyenheuft

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Neuroscience, Université catholique de Louvain

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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Saussez G, Bailly R, Araneda R, Paradis J, Ebner-Karestinos D, Klocker A, Sogbossi ES, Riquelme I, Brochard S, Bleyenheuft Y. Efficacy of integrating a semi-immersive virtual device in the HABIT-ILE intervention for children with unilateral cerebral palsy: a non-inferiority randomized controlled trial. J Neuroeng Rehabil. 2023 Jul 29;20(1):98. doi: 10.1186/s12984-023-01218-4.

Reference Type DERIVED
PMID: 37516873 (View on PubMed)

Other Identifiers

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B403201316810c

Identifier Type: -

Identifier Source: org_study_id