Association of a HABIT-ILE Course and a Home Programme on the Bimanual Performance of Children With Cerebral Palsy (PARTNERSHIP)

Fondation Ildys

Status: Begins enrollment in 2 months

Conditions: Cerebral Palsy

Treatments: Other: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Study type: Interventional

Funder types: Other

Identifiers

NCT06963151

RI2023_001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 3 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

PARTNER

Experimental group

Description:

Subjects will receive 35 hours of HABIT-ILE as camp format 3,5h/day, 5 days/week and 15 hours of home programme 1,5h/day, 5 day/week. These two procedures will be carried out concurrently over a 2-week period.

Treatment:

Other: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Other: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

HABIT-ILE

Experimental group

Description:

Subjects will receive 50 hours of HABIT-ILE as camp format 5h/day, 5 days/week for two weeks.

Treatment:

Other: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Other: Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities