Clinical trial NCT04395729: Functional Benefits of Multisite Surgery for the Upper Limb of Children With Cerebral Palsy
Official title: Functional Benefits of Multisite Surgery for the Upper Limb of Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy, Spastic
Cerebral Palsy, Dyskinetic
Infantile Hemiplegic Cerebral Palsy
Keywords: Upper limb
Contraction
Deformity
Multisite surgery
Treatment outcome
Lead sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Sponsor class: OTHER
First posted: 2020-05-20
Enrollment: 23
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Melbourne Assessment - Version 2
timeFrame: Available data up to 3 years before surgery and up to 2 years after surgery
Secondary outcomes:
measure: Assisting Hand Assessment - Version 5.0
timeFrame: Available data up to 3 years before surgery and up to 2 years after surgery
Other outcomes:
Locations:
city: Lyon
country: France
facility: Croix rouge française Centre Médico-Chirurgical de Réadaptation des Massues
Study officials:
affiliation: CMCR des Massues Croix rouge française
name: Emmanuelle Chaléat-Valayer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: