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Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy (HABIT-ILE)

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ClinicalTrials.gov Identifier: NCT04017871
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
Fondation paralysie cérébrale
Université Catholique de Louvain
University Pisa
University of Lausanne Hospitals
University Angers
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:

An urgent priority in the field of paediatric neurorehabilitation is the development of effective early motor interventions.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (= HABIT-ILE) applies the concepts of motor skill learning and intensive training to both the Upper Extremities (UE) and Lower Extremities (LE) and has been shown to improve aspects of motor function of the UE and LE in school age children with unilateral and bilateral Cerebral Palsy (CP) across the 3 levels of the International Classification of Functioning, Disability and Health (ICFDH). The principles and content of HABIT-ILE can be applied to pre-school children and this method is highly promising for early rehabilitation.


Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: MRI Other: Electro-Encephalography-High Density (children with unilateral PC only) Other: 3D and EMG analysis Other: care and classic activities Device: Accelerometers Not Applicable

Detailed Description:
The primary objective of this study is to evaluate the effect of two weeks of early HABIT-ILE on gross motor function in pre-school children with unilateral and and bilateral Cerebral Paralysy (CP), in comparison with two weeks of usual motor activity including usual rehabilitation (control group).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Evaluation of Functional, Neuroplastic and Biomechanical Changes Induced by an Intensive, Playful Early-morning Treatment Including Lower Limbs (EARLY-HABIT-ILE) in Preschool Children With Uni and Bilateral Cerebral Palsy
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : August 15, 2022
Estimated Study Completion Date : September 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional
10 days of intensive and structured motor therapy, 5 hours a day = 50h
Other: MRI
MRI at baseline and J90

Other: Electro-Encephalography-High Density (children with unilateral PC only)
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90

Other: 3D and EMG analysis
3D and EMG analysis at baseline and J90

Other: care and classic activities
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.

Device: Accelerometers
During 5 days a sensor at each wrist to quantify their movement.

Placebo Comparator: Control
10 days of care and classic activities
Other: MRI
MRI at baseline and J90

Other: Electro-Encephalography-High Density (children with unilateral PC only)
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90

Other: 3D and EMG analysis
3D and EMG analysis at baseline and J90

Other: care and classic activities
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.

Device: Accelerometers
During 5 days a sensor at each wrist to quantify their movement.




Primary Outcome Measures :
  1. Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only) [ Time Frame: 1 hour ]
    measures and describes how children with upper limb disability in one hand use his/her affected hand collaboratively with the non affected hand in bimanual play.The score range from 0 to 100 as a percentage. 100 is the best outcome.

  2. Gross Motor Function Measure (GMFM) (for bilateral CP only) [ Time Frame: 1 hour ]
    measures change in gross motor function over time in children with cerebral palsy. The score range from 0 to 100 as a percentage. 100 is the best outcome.



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Ages Eligible for Study:   12 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child with unilateral cerebral palsy or Child with bilateral cerebral palsy proven spastic or dyskinetic
  • Aged from 1 to 4 years old (12 to 59 months) (age corrected if prematurity) able to follow instructions and to be able to carry out all the evaluations, according to his age

Exclusion Criteria:

  • Age> 2 years old (35 months) or 4 years old (59 months) during the internship evaluation period
  • Uncontrolled epilepsy
  • History of botulinum toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period)
  • Visual or cognitive impairment that may interfere with the management
  • Common contraindications to magnetic resonance imaging (MRI) such as metal implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017871


Contacts
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Contact: Sylvain BROCHARD, PH +33298442021 sylvain.brochard@chu-brest.fr
Contact: Rodolphe BAILLY rodolphe.bailly@ildys.org

Locations
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France
Les Capucins Not yet recruiting
Angers, France
Contact: Michael DINOMAIS         
Fondation ILDYS - Site de Ty Yann Not yet recruiting
Brest, France
Contact: Sylvain BROCHARD         
Sponsors and Collaborators
University Hospital, Brest
Fondation paralysie cérébrale
Université Catholique de Louvain
University Pisa
University of Lausanne Hospitals
University Angers

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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT04017871     History of Changes
Other Study ID Numbers: EARLY_HABIT-ILE (29BRC19.0050)
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Brest:
Cerebral Palsy (CP)
pre-school children with unilateral and bilateral CP

Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases