Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive Motrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy (MOOV)
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Electro-Encephalography-High Density
3D and EMG analysis
care and classic activities
Sponsored by
About this trial
This is an interventional supportive care trial for Cerebral Palsy focused on measuring cerebral palsy (CP), pre-school children with bilateral CP
Eligibility Criteria
Inclusion Criteria:
- Child with bilateral cerebral palsy proven to be spastic or dyskinetic
- 1 to 4 years old inclusive (12 to 59 months) (age corrected if premature) able to follow instructions and to be able to carry out all the assessments, in accordance with his age
- Being matched to a child according to age, etiology of CP / classification of motor function (GMFCS)
- Signature of consent by the two holders of parental authority
Exclusion Criteria:
- Exceed 4 years and 11 months (59 months) during the internship evaluation period.
- Uncontrolled epilepsy.
- History of toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period).
- Visual or cognitive deficit preventing the child from seeing the games and interacting
- Usual 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
Gross Motor Function Measure (GMFM)
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
NCT ID
NCT04362800
First Posted
April 23, 2020
Last Updated
December 6, 2021
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT04362800
Brief Title
Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive Motrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy
Acronym
MOOV
Official Title
Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive MOtrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy: a Trial Multicentre Randomized Control With Medico-economic Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 19, 2021 (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
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
One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and corticospinal tracts, reducing motor impairments and their medium and long-term consequences in children with cerebral palsy. Although most of the growth, development and cortical organization takes place in the time course of the first 2 years of life, most studies investigating the effectiveness of intensive rehabilitation and associated neurophysiological mechanisms have been conducted in school-aged children (> 6 years). In addition, the vast majority of these studies were conducted in children with unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is therefore a priority to investigate the effectiveness of early interventions on the overall motor function of children with CP, especially in children with bilateral form of CP.
Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it possible to apply the concepts of structured motor learning and intensive treatment to both the upper limbs and the lower limbs and demonstrated improvements at both levels in school-aged children with unilateral CP and bilateral and then at all three International Classification of Functioning and Disability levels. The principles and content of HABIT-ILE can be applied to pre-school children and this method is promising for early neuro-rehabilitation.
Detailed Description
The main objective of this study is to evaluate the effect of 10 days (i.e. 50 hours) of early HABIT-ILE (HABIT-ILE) on the overall motor function of children aged 1 to 4 with bilateral cerebral palsy in comparison to 10 days (50h) of spontaneous overall 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 bilateral CP
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (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
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.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure (GMFM)
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 bilateral cerebral palsy proven to be spastic or dyskinetic
1 to 4 years old inclusive (12 to 59 months) (age corrected if premature) able to follow instructions and to be able to carry out all the assessments, in accordance with his age
Being matched to a child according to age, etiology of CP / classification of motor function (GMFCS)
Signature of consent by the two holders of parental authority
Exclusion Criteria:
Exceed 4 years and 11 months (59 months) during the internship evaluation period.
Uncontrolled epilepsy.
History of toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period).
Visual or cognitive deficit preventing the child from seeing the games and interacting
Usual contraindications to magnetic resonance imaging (MRI) such as metal implants.
Facility Information:
Facility Name
Les Capucins
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Fondation ILDYS - Site de Ty Yann
City
Brest
ZIP/Postal Code
29000
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.
Learn more about this trial
Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive Motrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy
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