PROPENSIX: pressure garment therapy using compressive dynamic Lycra® sleeve to improve bi-manual performance in unilateral cerebral palsy: a multicenter randomized controlled trial protocol

Trials

L. Beghin¹  A. Duhamel²  Y. Zagame³  S. Fritot⁴  C. Donskoff⁵  M. Toussaint-Thorin⁶  A. Gerard⁶  Y. Mohammad⁷  G. Letellier⁸  S. Masson⁹  L. Gottrand⁹ 

[1] CHU Lille, CIC1403 - Clinical Investigation Center, University of Lille;CHU Lille, ULR 2694-Metrics: évaluation des technologies de santé et des pratiques médicales, University of Lille;Medical Z;Médecine Physique et de Réadaptation Pédiatrique, CHU Amiens;Service de Soins de Suite et de Réadaptation Pédiatrique, Centre Paul Dottin;Service de Soins de Suites et Réadaptation pédiatrique, CHU Reims;Service d’Éducation et de Soins Spécialisés à Domicile APF;Établissement de Santé pour Enfants et Adolescents de la région Nantaise;Établissement de Soins de Suite et Réadaptation Pédiatrique Marc Sautelet APF;

关键词: Cerebral palsy;    Upper limb;    Children;    Splint;    Orthotic device;    Randomized controlled trial;   

DOI  :  10.1186/s13063-022-06041-1

来源: DOAJ

【 摘 要 】

Abstract Background Upper limb impairment affects activity and participation in children with unilateral cerebral palsy (UCP). Pressure garment therapy (PGT) using compressive dynamic Lycra® garments is an innovative intervention proposed for the management of cerebral palsy consequences. The PROPENSIX study aims to evaluate the efficacy of a therapy using a Lycra® sleeve as compared to a placebo sleeve to improve bi-manual performance measured by the Assisting Hand Assessment (AHA) in children with unilateral cerebral palsy. Methods The PROPENSIX trial is a multicenter, prospective, placebo-controlled, double-blinded, randomized study. One hundred children with UCP, aged from 5 to 10, are randomly assigned as soon as they are recruited in a 1:1 ratio to perform usual daily activities, especially activities involving bimanual performances, with Lycra® sleeve or placebo sleeve during 6 months. The primary endpoint is the change in bimanual performance from inclusion to 6 months, evaluated by AHA. The secondary endpoints evaluate changes from inclusion to 6 months in other dimensions of the International Classification of Functioning (ICF), upper limb movement capacity assessed by Quality of Upper Extremity Skill Test (QUEST), and health-related quality of life evaluated by Pediatric Quality of Life Inventory 3.0 Cerebral Palsy Module (PedsQLTM 3.0 CP Module) and in body structures and functions domain assessed by neuro-orthopedic examination and somatosensory evoked potentials (SEP). Discussion The PROPENSIX study is the largest randomized controlled trial (RCT) aiming to evaluate the efficacy of a PGT using compressive dynamic Lycra® sleeve in UCP. Enhancement of children’s bimanual performance at the end of the 6 months wear of the Lycra® sleeve should improve evidence regarding this type of treatment and expand discussion about their recommendation in clinical practice. Data from secondary outcomes assessments should bring interesting arguments to discuss the Lycra® sleeve action on mobility, tonus, and sensory impairments in children with unilateral cerebral palsy. Trial registration ClinicalTrials.gov NCT02086214 . Retrospectively registered on March 13, 2014 Trial status Study start data: December 2012. Recruitment status: completed. Primary completion date: April 2021. Estimated study completion date: December 2022. Protocol version 10 (date: February 2018).

【 授权许可】

Unknown