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

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.govNCT02086214. 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).

Safety and adherence of pressure garment therapy in children with upper limb unilateral cerebral palsy. Results from a randomized clinical trial ancillary analysis

“…This ancillary analysis is a part of the previously described ( 20 ) multicenter (seven study sites), prospective, double-blinded, randomized, placebo-controlled clinical trial. The present study is an ancillary analysis of 58 children included in one institutional specialized rehabilitation unit.…”

“…Size segments were measured at standard points of reference for circumferential measurements ( Supplementary Figure S1 ). It was a tailor-made sleeve which covered the arm from the axilla to half of the palm and the thumb, without covering other fingers ( 20 ). Lycra® sleeves were manufactured for each UCP child according to a randomization list within 1 week.…”

“…In both groups, the child was asked to wear the PGT Lycra® sleeve (active or placebo) for at least 3 h per day, every day, for 6 months ( 20 ). The PGT Lycra® sleeve was to be worn during usual daily activities, especially in activities involving bimanual performances, and during rehabilitation sessions.…”

“…The role of Pressure Garment Therapy (PGT) using a Lycra® arm sleeve is to increase sensory and proprioceptive awareness and reduce abnormal tone of the concerned body part ( 19 ). These properties may improve hand functional performance of children with UCP ( 20 ). PGT could be performed by an arm dynamic sleeve manufactured using Lycra®.…”

“…PGT could be performed by an arm dynamic sleeve manufactured using Lycra®. Lycra® sleeves have been widely used for burn therapy ( 21 , 22 ) but their efficacy as a PGT is unknown in UCP ( 20 ). The mechanical properties of Lycra® sleeves and their usability have been established in studies involving healthy and hemiplegic adult subjects ( 11 , 23 ).…”