Retrospective Study of Intensive Therapy Pathways in Children With Cerebral Palsy (P'TI-PARCOURS)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-17
SponsorCentre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française

About this trial

This retrospective single-center study aims to describe the care pathways of children with unilateral cerebral palsy (hemiplegia) who participated in intensive therapy programs (COLHEMI and/or Mini-COLHEMI) at the Centre des Massues since January 2010. The COLHEMI program (launched in 2010, for children aged 6-12) provides 70 hours of intensive motor learning-based therapy over 2 weeks, while the Mini-COLHEMI program (launched in 2020, for children from age 2) provides 30 hours over 2 weeks. The study will describe the immediate and medium-term impact of these programs on bimanual performance (Assisting Hand Assessment, AHA) and individualized goal attainment (Goal Attainment Scaling, GAS), analyze their impact on bimanual developmental trajectories using all available AHA scores, identify characteristics of good responders, and describe parent satisfaction. Approximately 75 patients will be included. Data are collected retrospectively from electronic and paper medical records by an occupational therapist.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Minor patient (age < 18 years)

Unilateral upper limb involvement due to Cerebral Palsy (hemiplegia)

Having participated in at least one intensive therapy program (COLHEMI and/or Mini-COLHEMI) since program launch in January 2010

Participation before June 30, 2026

Disqualifiers

None

Trial population

Children with unilateral cerebral palsy (hemiplegia) who participated in at least one COLHEMI or Mini-COLHEMI intensive therapy program at the Centre Médico-Chirurgical de Réadaptation des Massues between January 2010 and June 2026, with available pre- and post-program functional assessments in their medical records.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • COLHEMI program

    Other intervention

    the COLHEMI program (for children aged 6-12 years; 70 hours of motor learning-based intensive therapy over 2 weeks combining mCIMT, bimanual training, and goal-oriented therapy) and/or the Mini-COLHEMI program (for children from age 2; 30 hours over 2 weeks of 10 half-day sessions)

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Children with Unilateral Cerebral Palsy - COLHEMI / Mini-COLHEMI Intensive Therapy1 intervention

Trial outcomes

Primary outcomes

1

Structured Description of Care Pathway Including Intensive Therapy

Structured description of each patient's care pathway, integrating: type (COLHEMI or Mini-COLHEMI) and number of intensive therapy sessions attended; associated medical treatments (botulinum toxin injections - nature, muscles targeted, and timing relative to each intensive therapy episode); associated surgical treatments (nature and timing relative to each intensive therapy episode); and type of regular rehabilitation follow-up (private practice, medico-social, health institution).

Time frame
Full care trajectory from first intensive therapy program participation (from January 2010) to June 2026, collected retrospectively.

Secondary outcomes

1

Immediate Impact on Bimanual Performance - Assisting Hand Assessment (AHA)

Change in AHA score (version 5.0) between the pre-therapy assessment (within 3 months before program start) and the immediate post-therapy assessment (within 1 month after program end). The AHA evaluates the effectiveness of the assisting hand in bimanual performance in children aged 18 months to 18 years, scored on an interval scale from 0 to 100 AHA units. A difference of 5 AHA units is considered clinically significant. Inter-rater reliability: ICC = 0.98.

Time frame
AHA score closest to the start of intensive therapy (within 3 months before) compared to AHA score closest to the end of intensive therapy (within 1 month after).
2

Immediate Goal Attainment - Goal Attainment Scaling (GAS)

GAS scores immediately after each intensive therapy episode. Goal Attainment Scales are 5-level ordinal scales where -2 = baseline level, -1 = some progress below expected, 0 = expected level reached, +1 = slightly above expected, +2 = best possible outcome. Goals are individually defined and operationalized before each intensive therapy program based on the child's activity limitations in daily life. The proportion of patients reaching or exceeding their goal (score ≥ 0) is calculated for each goal and overall.

Time frame
Assessed immediately after each intensive therapy program.
3

Medium-Term Goal Attainment - Goal Attainment Scaling (GAS) at 3 Months

GAS scores at 3 months after each intensive therapy episode, using the same individualized goals defined before the program. A score ≥ 0 indicates that the expected level has been maintained or exceeded at 3 months. Comparison with immediate post-therapy GAS scores assesses maintenance of gains.

Time frame
Assessed 3 months after each intensive therapy program.
4

Impact on Bimanual Developmental Trajectory - Longitudinal AHA Scores

All AHA scores available in each patient's medical record are collected to model bimanual performance developmental trajectories. A linear mixed model (LMM) is applied with age as a fixed effect (natural maturation), COLHEMI/Mini-COLHEMI participation as an intervention variable, and random effects for individual baseline and rate of progression, to determine whether intensive therapy episodes induce a significant shift in performance level or progression rate relative to spontaneous development.

Time frame
All AHA scores available in the patient's medical record across the full care trajectory (from first available assessment to June 2026).

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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