Functional Benefits of Multisite Surgery for the Upper Limb of Children With Cerebral Palsy

NCT04395729 | Completed DMC

• 1 other identifier: RETRO-CHIR
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to investigate the impact of individualized multisite neuro-orthopedic surgery of the upper limb in children with Cerebral Palsy on unilateral functional capacities and bimanual performance. The investigators also assessed the attainment of individualized goals and tracked any potential factors that may have an impact on final results.

Conditions

Cerebral Palsy, Spastic; Cerebral Palsy, Dyskinetic; Infantile Hemiplegic Cerebral Palsy

Keywords

Upper limb; Contraction; Deformity; Multisite surgery; Treatment outcome

Outcome Measures

Primary Outcomes (1)

• Melbourne Assessment - Version 2

  The Melbourne Assessment evaluates unilateral upper limb functional capacities for children between 2.5 and 15 years of age with neurological impairment. It takes into account movement patterns, by characterizing the articular positioning observed during movements, as well as the fluidity of movement. Through 14 items analyzed along 4 axes (range of motion, precision, dexterity and fluidity), this test explores unilateral capacities to reach, grasp, release and manipulate simple objects. The evaluation is filmed according to a standardized protocol analyzed on video. The scoring is based on the video and the result is expressed as 4 scores in % for the areas of: range of motion, precision, dexterity, fluidity of movement. The reliability of the tool proved to be very good for the total score, for intra-examiner reproducibility (R=0.97) and inter-examiner reproducibility as well (R=0.95).

  Available data up to 3 years before surgery and up to 2 years after surgery

Secondary Outcomes (1)

• Assisting Hand Assessment - Version 5.0

  Available data up to 3 years before surgery and up to 2 years after surgery

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children (\<18 years) with cerebral palsy, presenting with unilateral upper limb injury. Surgical procedures consisted of one and/or the other of the following interventions (possibility of combining several procedures depending on the highly individualized surgical decision): Adductor Pollicis Brevis Disinsertion, Flexor Carpi Ulnaris Disinsertion, Lengthening of fingers flexors, Transfer (FCU) to the Extensor Carpi Radialis Brevis, Pronator teres Disinsertion, Lengthening of elbow flexors, Wrist arthrodesis.

You may qualify if:

• Age \<18 years at time of surgical project
• Unilateral upper limb injury due to Cerebral Palsy
• Having undergone neuro-orthopaedic surgery of the upper limb with prior evaluation and comparative evaluation after surgery (6 months)

You may not qualify if:

• \- Refusal to process medical data concerning the child for research purposes

Sponsors & Collaborators

• Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française: lead

Study Sites (1)

Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

Lyon, 69005, France

Location

MeSH Terms

Conditions

Cerebral Palsy; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Emmanuelle Chaléat-Valayer, MD, PhD

  CMCR des Massues Croix rouge française

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 20, 2020
• Study Start: July 9, 2020
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)