Clinical trial NCT06963151: Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children With Cerebral Palsy
Official title: Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children Aged 3 to 5 Years With Cerebral Palsy: a Multicentre Randomised Controlled Trial of Non-inferiority
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: HABIT-ILE
Intensive motor therapy
Motor skill learning
Parental Coaching
Children
Additional Relavant MeSH Terms
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Cerebral Palsy
Lead sponsor: Fondation Ildys
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
name: LP3C, University of Rennes 2
name: Claude Bernard University
name: IMT Atlantique Brest
name: INSERM UMR 1101
First posted: 2025-05-08
Enrollment: 66
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This non-inferiority, mixed-methods, multicentre randomised controlled trial will compare the effects of functional changes and families' resources at 3 months of the PARTNER programme (35h HABIT-ILE + 15h home programme) with the reference HABIT-ILE programme (50h) on the bimanual performance (Assisting Hand Assessment \[AHA\]) of 66 children with unilateral CP aged 3 to 5 years.

Detailed description: The PARTNERSHIP study will compare, for the first time, a mixed PARTNER camp modality, including a HABIT-ILE camp modality and a home programme modality, with parental coaching, to a reference HABIT-ILE modality.

The children in the PARTNER group will therefore spend 3.5 hours a day for 10 days in HABIT-ILE therapy, plus 1.5 hours a day for 10 days in home activities carried out by the family.

The children in the HABIT-ILE group will have 5 hours of HABIT-ILE therapy per day, the reference modality.

A non-inferiority, mixed-methods, multicentre randomised controlled trial will be conducted to compare the effectiveness of the PARTNER programme with the reference HABIT-ILE programme on the bimanual performance (Assisting Hand Assessment \[AHA\]) of children with unilateral CP aged 3 to 5 years. The secondary aims are to compare the 3-month effectiveness of the programmes on occupational performance, functional skills and upper limb activity levels, as well as families' resources, the parent-child relationship, the quantity and quality of resources available in the home to stimulate the child's motor development, and parental perceptions of their child's disability and their child's abilities (qualitative study). The tertiary aim is to conduct a cost-effectiveness analysis of care consumption in each group up to 6 months after the end of the programmes.

Target recruitment is 66 children (33 in each group) from 3 centres in France. Outcomes will be evaluated before the interventions, immediately after, at 3 months and up to 6 months for the cost-effectiveness analysis. Families in the PARTNER group will receive specific coaching and extensive support to perform the home programme. The coaching will focus on enhancing their resources.

Eligibility criteria: Inclusion Criteria:

1. Child with unilateral CP confirmed by a physician
2. Child aged between 3 years and 5 years 11 months (corrected age) at study entry
3. Ability to grasp a light object and lift it ≥15cm above the table using the affected hand.
4. Ability to understand instructions and complete all assessments.
5. Matched with another child based on age (± 3 months), CP aetiology, and Manual Ability Classification System (MACS) level.
6. Written informed consent obtained from a parent or legal guardian.
7. Commitment to having the same parent or guardian participate throughout the study.

Exclusion Criteria:

1. Diagnosis of ataxic CP.
2. Uncontrolled epilepsy.
3. History of botulinum toxin injection or surgery within 6 months of study entry or scheduled within 3 months of the intervention (ie, during the study period).
4. Visual or auditory deficits that could interfere with participation in the study.

Primary outcomes:
measure: Assisting Hand Assessment (AHA)
timeFrame: At the baseline (T0), at the end of the camp (T1: T0 + 21 + 2 days), and during the follow-up visit (T2: T0 + 90+2 days)
Secondary outcomes:
measure: Canadian Measure of Occupational Performance (COPM)
timeFrame: At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2 days)
measure: Pediatric Evaluation of Disability Inventory Computer Adaptative Test (PEDI-CAT)
timeFrame: At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0 +90+2 days)
measure: Gross motor activity and upper limb activity
timeFrame: 4 days at home before T0, during the camp, 4days at home before T2
measure: Changes of family resources: World health organization quality of life - Bref (WHOQOL-Bref)
timeFrame: At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2 days)
measure: Changes of family resources: The Enabling Practice Scale (EPS)
timeFrame: At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follo-up visit (T2: T0+90+2 days)
measure: Changes of family resources: The Psychological Empowerment Scale (PES)
timeFrame: At the baseline (T0), at the end of the camp (T1: T0+ 21+2 days), and during the follow-up visit (T2: T0+ 90+2days)
measure: Changes of family resources: The Parental Stress Inventory (PSI)
timeFrame: At the baseline (T0), at the end of the camp (T1: T0+ 21±2 days)), and during the follow-up visit (T2: T0+ 90±2 days)
measure: Parent-Child Early Relational Assessment (PCERA)
timeFrame: At the baseline (T0), at the end of the camp (T1: T0+ 21±2 days), and during the follow-up visit (T2: T0+ 90±2 days)
measure: Parental representations: PARTNER programme
timeFrame: At the baseline (T0), and during the follow-up visit (T2: T0+ 90±2 days)
measure: Cost-effectiveness analysis
timeFrame: From baseline (T0) to the end of the camp (T1: T0+ 21±2 days
measure: Impact on care consumption
timeFrame: From baseline (T0) to 6 months post intervention.
Other outcomes:
Locations:
city: Brest cedex 2
country: France
facility: Fondation ILDYS
Study officials:
affiliation: Fondation Ildys
name: Rodolphe BAILLY
role: PRINCIPAL_INVESTIGATOR
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