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Clinical Trials in France / NCT07891078
Recruiting Observational

Functional Benefits of Multisite Upper Limb Surgery in Children With Unilateral Cerebral Palsy (RETRO-CHIRc)

NCT07891078 · tracked via the Priya Life Science France tracker
Sponsor
Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Phase
Observational
Started
2026-07-01
Last updated
2026-10-23

Condition(s) studied

Cerebral PalsyHemiplegia

Study summary

This retrospective study evaluates the functional impact of individualized multisite neuro-orthopedic upper limb surgery in children with unilateral cerebral palsy (hemiplegic CP). Using a before-and-after design in which each patient serves as their own control, the study analyzes data collected in routine clinical care up to 3-5 years before and 1-2 years after surgery. The primary outcome is upper limb function as measured by the Modified Melbourne Assessment (MA2), which assesses range of motion and dexterity. Secondary outcomes include unimanual precision and fluidity (MA2), global manual dexterity (Box and Block Test), bimanual performance (Assisting Hand Assessment), and patient/parent satisfaction. Approximately 70 patients operated at the Centre Médico-Chirurgical de Réadaptation des Massues between January 2012 and June 2025 will be included. The study also aims to identify factors influencing surgical outcomes, such as age at surgery, associated cognitive or sensory impairments, and adherence to post-operative orthotic protocols.

Eligibility

Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
INCLUSION CRITERIA * Minor patient (age \< 18 years at the time of the surgical project) * Unilateral upper limb involvement due to Cerebral Palsy * Having undergone neuro-orthopedic upper limb surgery * Surgery performed by the surgeon who participated in the multidisciplinary surgical planning meeting (EMC) * Surgery performed between January 1, 2012 and June 30, 2025 * Availability of at least one pre-operative assessment and one comparative post-operative assessment at more than 12 months after surgery * Followed at the CMCR des Massues NON-INCLUSION CRITERIA * Refusal of medical data processing for research purposes

Primary outcome measure(s)

  • Upper Limb Range of Motion and Dexterity - Modified Melbourne Assessment (MA2) — Data collected retrospectively up to 3 years (or 5 years if available) before surgery and up to 1 year (or 2 years if available) after surgery.
    Scores for the "Range of Motion" and "Dexterity" dimensions of the Modified Melbourne Assessment version 2 (MA2). The MA2 evaluates unilateral upper limb quality of function during tasks involving object approach, grasp, release, and manipulation in children aged 2.5 to 15 years with neurological impairment. Assessment is video-recorded during routine clinical care and scored retrospectively by an occupational therapist. Results are expressed as percentages for each of the four MA2 domains. Inter-rater reliability is excellent (R=0.95) and intra-rater reliability is very good (R=0.97).

Trial sites (1)

FacilityCityRegionStatus
Centre Médico chirurgical de Réadaptation des Massues Lyon France Recruiting

More Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française trials in France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07891078 on ClinicalTrials.gov ↗ ← All trials in France