Condition or disease | Intervention/treatment | Phase |
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Cerebral Palsy | Behavioral: Hand Arm Bimanual Intensive Therapy Including Lower Extremities Behavioral: Conventional physical and occupational therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | June 14, 2018 |
Actual Primary Completion Date : | June 20, 2020 |
Actual Study Completion Date : | July 15, 2020 |
Arm | Intervention/treatment |
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Active Comparator: control group
high/low dosage intervention, intensive or not (motor function rehabilitation)
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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
|
Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Institute of Neuroscience, Université catholique de Louvain | |
Brussels, Belgium, 1200 |
Tracking Information | |||||
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First Submitted Date ICMJE | June 21, 2018 | ||||
First Posted Date ICMJE | April 29, 2019 | ||||
Last Update Posted Date | December 21, 2020 | ||||
Actual Study Start Date ICMJE | June 14, 2018 | ||||
Actual Primary Completion Date | June 20, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation | ||||
Official Title ICMJE | 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 | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Cerebral Palsy | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
64 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | July 15, 2020 | ||||
Actual Primary Completion Date | June 20, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 5 Years to 18 Years (Child, Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Belgium | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03930836 | ||||
Other Study ID Numbers ICMJE | B403201316810c | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Yannick Bleyenheuft, Université Catholique de Louvain | ||||
Study Sponsor ICMJE | Université Catholique de Louvain | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Université Catholique de Louvain | ||||
Verification Date | December 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |