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

• Published in: Current controlled trials in cardiovascular medicine Vol. 23; no. 1; pp. 117 - 13
• Main Authors: Gerard, A, Toussaint-Thorin, M, Mohammad, Y, Letellier, G, Fritot, S, Masson, S, Duhamel, A, Donskoff, C, Zagame, Y, Beghin, L, Gottrand, L
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 05-02-2022; BioMed Central; BMC
• Subjects: Aged; Care and treatment; Cerebral palsy; Cerebral Palsy - diagnosis; Cerebral Palsy - therapy; Child; Children; Clinical trials; Consent; Diagnosis; Ethics; Hand; Humans; Life Sciences; Materials; Multicenter Studies as Topic; Orthotic device; Pediatrics; Quality of Life; Randomized controlled trial; Randomized Controlled Trials as Topic; Registration; Spasticity; Splint; Splints (Surgery); Statistical analysis; Study Protocol; Testing; Upper Extremity; Upper limb; France; Cerebral palsy; Pressure garment therapy; Placebo; Upper limb; Children; Orthotic device; Compressive dynamic Lycra® sleeve; Randomized controlled trial; Bimanual performance; Splint
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-022-06041-1

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.
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).
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.
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).