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PROPENSIX: pressure garment therapy using compressive dynamic Lycra® sleeve to improve bi-manual performance in
A Gerard1, M Toussaint-Thorin2, Y Mohammad3,4
1Service de Soins de Suites et Réadaptation pédiatrique, CHU Reims, AMH 47 Rue Cognacq-Jay, F-51092, Reims, France. agerard@chu-reims.fr.
Insights
This study investigated if Lycra® sleeves improve bimanual performance in children with unilateral cerebral palsy (UCP). Results are expected to guide clinical recommendations for pressure garment therapy (PGT) in UCP management.
Area of Science:
- Pediatric rehabilitation
- Neuroscience
- Biomedical engineering
Background:
- Unilateral cerebral palsy (UCP) significantly impacts upper limb function, affecting daily activities and participation in children.
- Pressure garment therapy (PGT) using compressive dynamic Lycra® sleeves is an emerging intervention for managing UCP-related impairments.
- The PROPENSIX study addresses the need for evidence on PGT's efficacy in pediatric UCP.
Purpose of the Study:
- To evaluate the efficacy of Lycra® sleeve therapy compared to a placebo in enhancing bimanual performance in children with UCP.
- To assess the impact of PGT on various functional domains outlined by the International Classification of Functioning (ICF).
- To provide robust evidence for the clinical application of PGT in UCP.
Main Methods:
- A multicenter, prospective, double-blinded, randomized placebo-controlled trial (PROPENSIX).
- 100 children (5-10 years) with UCP were randomized 1:1 to wear either a Lycra® sleeve or a placebo sleeve for 6 months.
- Primary outcome: change in bimanual performance (Assisting Hand Assessment - AHA). Secondary outcomes: upper limb function (QUEST), quality of life (PedsQL™ 3.0 CP), and neuro-orthopedic/sensory assessments (SEP).
Main Results:
- The study is the largest randomized controlled trial (RCT) to date assessing PGT with Lycra® sleeves in UCP.
- Data collection for primary and secondary outcomes is complete, with analysis pending.
- Expected findings will contribute significant evidence regarding PGT's benefits for bimanual performance and other functional domains in UCP.
Conclusions:
- The PROPENSIX study is poised to enhance the evidence base for pressure garment therapy in children with unilateral cerebral palsy.
- Results are anticipated to inform clinical practice guidelines and recommendations for Lycra® sleeve use in UCP.
- Further analysis of secondary outcomes will elucidate the sleeve's effects on motor control, muscle tone, and sensory processing in pediatric UCP.
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).
