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Table 1 Trial registration data, design of the study, and enrollment criteria

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

Data category Information
Primary registry ClinicalTrials.gov: NCT02086214, registered on March 13, 2014
Secondary identifying numbers ANSM ID-RCB number: 2011-A01129-32
Ethics committee: CPP 12/05
Sponsor Lille University Hospital
Contact Maison Régionale de la Recherche Clinique, CHU Lille, Boulevard du Professeur Leclercq, F-59037 LILLE CEDEX FRANCE
Tel. : 03 20 44 68 91
Mail : ciclille@chru-lille.fr
Short title PROPENSIX study
Scientific title PROPENSIX: Pressure Garment Therapy using compressive dynamic Lycra® sleeve to improve bi-manual performance in unilateral cerebral palsy, a multicenter randomized controlled trial
Country of recruitment France
Inclusion criteria Unilateral cerebral palsy (perinatal or antenatal etiology), 5 to 10 years old, social insurance, written informed consent
Exclusion criteria Allergy to Lycra®, contra-indication to pressure therapy (e.g., skin lesions, allergic contact dermatitis), behavior or speech troubles, Botulinum Neurotoxin received within the 4 preceding months on the impaired arm, tutorship or curatorship, predictable lack of compliance
Intervention Treatment: Lycra® sleeve (Medical Z®, pressure = 15 to 25 mmHg)
Placebo: Placebo sleeve (Medical Z®, pressure < 5 mmHg)
Study type Interventional
Study design Prospective, randomized, placebo-controlled, parallel assignment, double-blinded, multicenter, superiority trial
Target sample size 100
Primary outcome Performance, evaluated by AHA (Time frame: 6 months)
Secondary outcomes Capacity, evaluated by QUEST (Time frame: 6 months)
Body structures and functions, evaluated by SEP and neuro-orthopedic examination (Time frame: 6 months)
Participation, evaluated by PedsQLTM 3.0 CP Module (Time frame: 6 months)
Estimated primary completion date April 2021
  1. AHA Assisting Hand Assessment, QUEST Quality of Upper Extremity Skill Test, PedsQL™ 3.0 CP Module: Pediatric Quality of Life Inventory 3.0 Cerebral Palsy Module