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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)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Electro-Encephalography-High Density (children with unilateral PC only)
3D and EMG analysis
care and classic activities
Accelerometers
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring Cerebral Palsy (CP), pre-school children with unilateral and bilateral CP

Eligibility Criteria

12 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Les Capucins
  • Fondation ILDYS - Site de Ty Yann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Interventional

Control

Arm Description

10 days of intensive and structured motor therapy, 5 hours a day = 50h

10 days of care and classic activities

Outcomes

Primary Outcome Measures

Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only)
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.
Gross Motor Function Measure (GMFM) (for bilateral CP only)
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.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2019
Last Updated
December 6, 2021
Sponsor
University Hospital, Brest
Collaborators
Fondation Paralysie Cérébrale, Université Catholique de Louvain, University Pisa, University of Lausanne Hospitals, University Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04017871
Brief 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
Acronym
HABIT-ILE
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 18, 2019 (Actual)
Primary Completion Date
September 17, 2021 (Actual)
Study Completion Date
September 17, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Fondation Paralysie Cérébrale, Université Catholique de Louvain, University Pisa, University of Lausanne Hospitals, University Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy (CP), pre-school children with unilateral and bilateral CP

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Experimental
Arm Description
10 days of intensive and structured motor therapy, 5 hours a day = 50h
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
10 days of care and classic activities
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
MRI at baseline and J90
Intervention Type
Other
Intervention Name(s)
Electro-Encephalography-High Density (children with unilateral PC only)
Intervention Description
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
Intervention Type
Other
Intervention Name(s)
3D and EMG analysis
Intervention Description
3D and EMG analysis at baseline and J90
Intervention Type
Other
Intervention Name(s)
care and classic activities
Intervention Description
physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
Intervention Type
Device
Intervention Name(s)
Accelerometers
Intervention Description
During 5 days a sensor at each wrist to quantify their movement.
Primary Outcome Measure Information:
Title
Assistive Hand Assesment (AHA/miniAHA) (for unilateral CP only)
Description
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.
Time Frame
1 hour
Title
Gross Motor Function Measure (GMFM) (for bilateral CP only)
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Les Capucins
City
Angers
Country
France
Facility Name
Fondation ILDYS - Site de Ty Yann
City
Brest
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing 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.
Citations:
PubMed Identifier
32532249
Citation
Araneda R, Sizonenko SV, Newman CJ, Dinomais M, Le Gal G, Ebner-Karestinos D, Paradis J, Klocker A, Saussez G, Demas J, Bailly R, Bouvier S, Nowak E, Guzzetta A, Riquelme I, Brochard S, Bleyenheuft Y. Protocol of changes induced by early Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (e-HABIT-ILE) in pre-school children with bilateral cerebral palsy: a multisite randomized controlled trial. BMC Neurol. 2020 Jun 12;20(1):243. doi: 10.1186/s12883-020-01820-2.
Results Reference
derived

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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

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