NCT07891078

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
1mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Jul 2026Dec 2026

First Submitted

Initial submission to the registry

June 18, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

2 months

First QC Date

June 18, 2026

Last Update Submit

October 20, 2026

Conditions

Keywords

Cerebral PalsyUnilateral cerebral palsyHemiplegiaUpper limb surgeryMultisite neuro-orthopedic surgeryMelbourne AssessmentAssisting Hand AssessmentPediatric rehabilitationFunctional outcomes

Outcome Measures

Primary Outcomes (1)

  • Upper Limb Range of Motion and Dexterity - Modified Melbourne Assessment (MA2)

    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).

    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.

Secondary Outcomes (11)

  • Unimanual Precision and Fluidity - 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.

  • Global Manual Dexterity - Box and Block Test (BBT)

    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.

  • Bimanual Performance - Assisting Hand Assessment (AHA)

    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.

  • Patient and Parent Satisfaction with Surgical Outcomes - Goal Attainment

    Postoperative assessment, between 12 and 36 months after surgery

  • Overall Patient and Parent Satisfaction with Surgical Treatment

    minimum 12 months post-surgery, assessed through study completion

  • +6 more secondary outcomes

Study Arms (1)

Children with Unilateral Cerebral Palsy - Multisite Upper Limb Surgery

Retrospective cohort of children with unilateral cerebral palsy (hemiplegia) who underwent individualized multisite neuro-orthopedic upper limb surgery at the Centre des Massues between January 2012 and June 2025. Surgical procedures were individualized and may include one or more of the following: short adductor of thumb release, flexor carpi ulnaris (FCU) release, FCU transfer to extensor carpi radialis brevis, finger flexor lengthening, round pronator release, elbow flexor lengthening, wrist arthrodesis, and other procedures. All patients underwent pre-surgical multidisciplinary evaluation, specialized surgery, and structured post-operative rehabilitation including orthoses and occupational therapy.

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with unilateral cerebral palsy (hemiplegia) who underwent individualized multisite neuro-orthopedic upper limb surgery at the Centre Médico-Chirurgical de Réadaptation des Massues between January 2012 and June 2025, with available pre- and post-operative functional assessments.

You may qualify if:

  • 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
  • Refusal of medical data processing for research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Médico chirurgical de Réadaptation des Massues

Lyon, 69005, France

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Condition Hierarchy (Ancestors)

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

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

October 23, 2026

Study Start

July 1, 2026

Primary Completion

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations