NCT07683455

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
9mo left

Started Sep 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 6, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

June 18, 2026

Last Update Submit

July 2, 2026

Conditions

Keywords

Cerebral PalsyUnilateral cerebral palsyHemiplegiaIntensive therapyConstraint-induced movement therapyBimanual trainingHABITAssisting Hand AssessmentGoal Attainment ScalingPediatric rehabilitationCare pathway

Outcome Measures

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).

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

Secondary Outcomes (6)

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

    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)

    Assessed immediately after each intensive therapy program.

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

    Assessed 3 months after each intensive therapy program.

  • Impact on Bimanual Developmental Trajectory - Longitudinal AHA Scores

    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

    Variables collected at baseline (pre-therapy) and analyzed against response status defined at immediate post-therapy and 3-month assessments.

  • +1 more secondary outcomes

Study Arms (1)

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.

Other: COLHEMI program

Interventions

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)

Children with Unilateral Cerebral Palsy - COLHEMI / Mini-COLHEMI Intensive Therapy

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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
  • Followed at the CMCR des Massues
  • Parental opposition to medical data processing for research purposes
  • Incomplete medical record

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral PalsyHemiplegiaHabits

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Central Study Contacts

Rachel Bard-Pondarre

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2026

First Posted

July 6, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 6, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share