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