- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04017871
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)
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Angers, France
- Les Capucins
-
Brest, France
- Fondation ILDYS - Site de Ty Yann
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Interventional
10 days of intensive and structured motor therapy, 5 hours a day = 50h
|
MRI at baseline and J90
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
3D and EMG analysis at baseline and J90
physiotherapy and psychomotility.
As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
During 5 days a sensor at each wrist to quantify their movement.
|
Placebo Comparator: Control
10 days of care and classic activities
|
MRI at baseline and J90
Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
3D and EMG analysis at baseline and J90
physiotherapy and psychomotility.
As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
During 5 days a sensor at each wrist to quantify their movement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 hour
|
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.
|
1 hour
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EARLY_HABIT-ILE (29BRC19.0050)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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