Efficacy of hand-arm bimanual intensive therapy including lower extremities (HABIT-ILE) in young children with bilateral cerebral palsy (GMFCS III-IV) in a low and middle-income country: protocol of a randomised controlled trial.

introductionCerebral palsy (CP) is highly prevalent in sub-Saharan Africa, where clinically-based studies have shown a considerable over-representation of the severe bilateral subtype. However, children's access to rehabilitation care is limited by many local factors, notably the lacking of rehabilitation services, insufficient knowledge of caregivers and financial constraints. In such a context there is an urgent need for studies of the evidence-based rehabilitation approach. Here, we describe the protocol of a randomised controlled study to investigate the efficacy of Hand-Arm Bimanual Intensive Therapy Including the Lower Extremities (HABIT-ILE) in young children with bilateral CP in Benin Republic, a representative low and middle-income country of western Africa. METHODS AND ANALYSIS: Forty children with bilateral CP aged between 24 and 59 months and with level III-IV in the gross motor function classification will be randomised to either a high intensity conventional therapy or HABIT-ILE therapy. Both therapies will be delivered as a day-camp model over 2 weeks to a total of 50 hours (5 hours per day). The assessor-blinded primary outcomes will include the gross motor function measure and both hands assessment. Secondary outcomes will be the adapted version of the ACTIVLIM-CP questionnaire, the Canadian Occupational Performance Measure, and a perception of CP interview form. Children will be assessed at baseline, after intervention and at 6-week follow-up. A 2 (group)×3 (test sessions) repeated analysis of variance will evaluate changes after the interventions. ETHICS AND DISSEMINATION: This study has been approved by the ethics committee of the rehabilitation department of the National Teaching Hospital Hubert Koutoukou Maga of Cotonou, Benin (approval decision: N°01-2019/MS/CNHU-HKM/CEI/CUMPR). All participants' parents/caregivers will provide their written informed consent. Data will be managed with confidentiality. TRIAL REGISTRATION NUMBER: PACTR201911894444879.