TY - JOUR
T1 - 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
T2 - protocol of a randomised controlled trial
AU - Sogbossi, Emmanuel Segnon
AU - Sotindjo Adon, Solange
AU - Adjagodo, Leontine
AU - Dossou, Solange
AU - Dakè, Hyppolite
AU - Ebner-Karestinos, Daniela
AU - Araneda, Rodrigo
AU - Saussez, Geoffroy
AU - Paradis, Julie
AU - Kpadonou, Toussaint G.
AU - Bleyenheuft, Yannick
N1 - Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2021/10/5
Y1 - 2021/10/5
N2 - Introduction Cerebral 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.
AB - Introduction Cerebral 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.
KW - developmental neurology & neurodisability
KW - paediatric neurology
KW - rehabilitation medicine
UR - http://www.scopus.com/inward/record.url?scp=85116882817&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-050958
DO - 10.1136/bmjopen-2021-050958
M3 - Article
C2 - 34610941
AN - SCOPUS:85116882817
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 10
M1 - 050958
ER -