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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.
Background and Rationale Cerebral palsy (CP) is the most common cause of neurological disability in children, with a prevalence of approximately 2-2.5 per 1,000 live births in Europe. Hemiplegia, which accounts for approximately 30% of CP cases, predominantly affects the upper limb, impairing unimanual capacities, bimanual performance, and independence in activities of daily living.
The 2019 systematic review of evidence-based interventions for CP and subsequent international and French (HAS 2021) clinical practice guidelines strongly support intensive therapy approaches, including modified constraint-induced movement therapy (mCIMT), Hand and Arm Bimanual Intensive Training (HABIT), and HABIT-ILE. French HAS guidelines specifically recommend intensive rehabilitation programs of 60-90 hours incorporating motor learning principles targeting individualized functional goals.
Despite the strength of these recommendations, access to intensive therapy in France has historically been limited, leading many families to seek programs abroad. The Centre des Massues has proactively developed in-house intensive therapy programs integrated within its standard care pathway:
While these programs have been running for over a decade and generate systematic pre/post evaluations as part of routine care, their long-term impact on bimanual developmental trajectories and the factors associated with good response have not yet been formally studied.
Study Design Retrospective single-center study (Research Not Involving Human Subjects - RNIPH), using data collected during routine clinical care. Each patient serves as their own control (before/after design). All available longitudinal AHA data from each patient's medical record are collected to model bimanual developmental trajectories and quantify the effect of intensive therapy episodes relative to spontaneous maturation.
Data Collection and Management Data are collected retrospectively by Audrey COMBEY (occupational therapist) from electronic and paper medical records and occupational therapy databases. The dataset is pseudonymized using an inclusion number. The linkage table is maintained by the principal investigator (Audrey COMBEY) and by delegation by Rachel BARD-PONDARRE, stored on the Centre des Massues internal server with password protection. No data transfer to subcontractors is planned. Data will be retained for 3 years after study completion and archived for 15 years following last publication.
Statistical Analysis Approximately 75 patients will be included. Descriptive statistics will characterize the population (age, sex, side of hemiplegia, type of hemiplegia, follow-up setting, geographic distance to the Centre des Massues, history of botulinum toxin injections, intensive therapy sessions, and surgery). AHA score changes before and after each intensive therapy episode will be evaluated using paired Student t-tests (or Wilcoxon signed-rank test if normality is not met). GAS scores will be described by descriptive statistics and the proportion of patients reaching or exceeding their goal (score ≥ 0) will be calculated. A linear mixed model (LMM) will be applied to model bimanual developmental trajectories over time, with age as a fixed effect (natural maturation), COLHEMI/Mini-COLHEMI participation as an intervention variable, and random effects for individual baseline and progression rate. Logistic regression will be used to identify characteristics associated with good response. Parent satisfaction will be described by descriptive statistics per item. A 5% significance threshold is applied throughout. Analyses will be performed in R by Julie ROZAIRE.
Regulatory and Ethical Framework This study meets the definition of an internal study under French CNIL regulations and is classified as Research Not Involving Human Subjects (RNIPH) under the Jardé Law. It is exempt from CNIL authorization. The study is registered in the internal data processing activities register of the Centre des Massues (RGPD Article 30). The protocol has been submitted to the Internal Ethics Committee for Research (CIER) of the GHICL (IRB 00013355) and is pending approval.
Dissemination Results will be published in a peer-reviewed journal and presented at scientific society meetings (posters and/or oral communications). The principal investigator will be listed as first or last author. The study statistician will be co-author.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with Unilateral Cerebral Palsy - COLHEMI / Mini-COLHEMI Intensive Therapy | Retrospective cohort of children with unilateral cerebral palsy (hemiplegia) who participated in at least one intensive therapy program at the Centre des Massues between January 2010 and June 2026: 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). Participants may have undergone one or multiple sessions of these programs across their care trajectory, and may have received associated medical treatments (botulinum toxin injections) or surgical interventions before or after intensive therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COLHEMI program | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Full care trajectory from first intensive therapy program participation (from January 2010) to June 2026, collected retrospectively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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INCLUSION CRITERIA
NON-INCLUSION CRITERIA
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Rozaire | Contact | +334 72 38 11 43 | julie.rozaire@croix-rouge.fr | |
| Rachel Bard-Pondarre | Contact |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D006429 | Hemiplegia |
| D006184 | Habits |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| 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). |
| 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. | Assessed immediately after each intensive therapy program. |
| 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. | Assessed 3 months after each intensive therapy program. |
| 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. | All AHA scores available in the patient's medical record across the full care trajectory (from first available assessment to June 2026). |
| Characteristics of Good Responders to Intensive Therapy | A patient is defined as a "good responder" if both of the following conditions are simultaneously met at immediate post-therapy and at 3-month assessments: (1) AHA score change ≥ 5 points (clinically significant difference); and (2) mean GAS score ≥ 0 across all goals defined at the start of intensive therapy. Logistic regression will be used to identify patient characteristics (age, sex, side and type of hemiplegia, follow-up setting, history of botulinum toxin injections, history of surgery, number of previous intensive therapy episodes) associated with good responder status. | Variables collected at baseline (pre-therapy) and analyzed against response status defined at immediate post-therapy and 3-month assessments. |
| Parent Satisfaction with Intensive Therapy Programs | Parent satisfaction assessed via a structured questionnaire distributed at the end of each intensive therapy program as part of routine care, using Visual Analogue Scales (0-10) on the following dimensions: program duration, proposed activities, child's enjoyment and engagement, perceived fatigue, social interactions with peers, progress toward individualized goals, other perceived progress, and parent workshop experience. Described by descriptive statistics per item (mean and standard deviation). | 2 weeks |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |