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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy, Dyskinetic; Cerebral Palsy, Spastic; Infantile Hemiplegic Cerebral Palsy

Detailed Description

Cerebral Palsy is responsible for the most common neurological disorders in children. Although the primary lesion is non-evolutionary, the secondary consequences are evolutive, with neuro-orthopaedic degradation leading to soft tissue retraction and osteo-articular deformities. Hemiplegia occurs in approximately 30% of cases of Cerebral Palsy, and tone disorders (spasticity, dyskinesia) affecting the upper limb generally impact function, both in unilateral capacities (range of motion, dexterity, and fluidity of movement), and in bimanual performance. The focal treatment of spasticity by botulinum toxin injections, in combination with specific occupational therapy training, has proven to be effective in improving targeted functional goals. However, there is little evidence today of the effectiveness of treatment for the management of upper limb retraction and deformity, whether by stretching, orthosis/plaster or even surgery. And apart from its effectiveness on body structure, the functional effects of upper limb surgery in Cerebral Palsy have been little explored. 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, by using such tools as the Melbourne Assessment (Version 2) and the Assisting Hand Assessment (Version 5.0).

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Audrey Combey, OT; Phone Number: +33 (0)4 72 38 46 20; Email: audrey.combey@croix-rouge.fr
• Study Contact Backup: Name: Rachel Bard-Pondarré, OT; Phone Number: +33 (0)4 72 38 46 20; Email: bard.rachel@orange.fr

Study Locations

• France
  • Lyon, France, 69005
    • Recruiting
    • Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assisting Hand Assessment - Version 5.0	The Assisting Hand Assessment (AHA) evaluates the effectiveness of the use of the assistant hand in bimanual performance in children with unilateral impairment between 18 months and 18 years of age. The test is scored on the video recording of the bimanual performance observation session, through 20 items rated on a rating scale between 1=ineffective and 4=effective; the different AHA items characterize the general use of the upper limb, the use of the arm, the grasp-release domain, fine motor adjustment and coordination. The total raw score is reduced to an interval score between 0 and 100. The reliability of the AHA has been shown to be very good for the total score, both intra-examiner (CCI= 0.99) and inter-examiner (CCI= 0.98). A difference of 5 points on the interval scale 0-100 is considered a significant difference.	Available data up to 3 years before surgery and up to 2 years after surgery

Collaborators and Investigators

• Sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
• Investigators: Principal Investigator: Emmanuelle Chaléat-Valayer, MD, PhD, CMCR des Massues Croix rouge française

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Upper limb; Treatment outcome; Deformity; Contraction; Multisite surgery
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: RETRO-CHIR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No