Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911894444879 Date of Approval: 05/11/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in young children with severe bilateral cerebral palsy (GMFCS III-IV) in a Low-Income Country of West-Africa: a randomized controlled trial.
Official scientific title Efficacy of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in young children with severe bilateral cerebral palsy (GMFCS III-IV) in a Low-Income Country of West-Africa: a randomized controlled trial.
Brief summary describing the background and objectives of the trial Cerebral palsy (CP) is the most common cause of pediatric motor disability worldwide with a relatively higher prevalence and a higher proportion of bilateral and severe clinical subtype (GMFCS III-V) in Low-Income Countries (LICs) such as in Africa. Unfortunately, rehabilitation services are still unavailable, missing in the care provided to children with CP in these areas. Evidence-based rehabilitation therapies for children with CP are those based on the principles of motor learning and control, generally delivered in a camp-model, several hours daily for two weeks. While most of them focused on the upper extremity, the Hand-Arm Bimanual Intensive Therapy including the Lower extremities (HABIT-ILE) engaged the whole body (both the upper and lower extremities with the trunk). Therefore, it seems more appropriate in LICs with the high percentage of bilateral CP. Furthermore, the two weeks camp-model approach seems more interesting in alleviating the burden associated with the displacements of the children for the rehabilitation care most often spread over months. The objective of this study is to investigate the efficacy of the HABIT-ILE in children with severe bilateral CP in a low-income country (Republic of Benin) of West-Africa. Secondarily, we aimed to assess the possible effect of HABIT-ILE on the perception of CP in parents of affected children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 27/11/2019
Actual trial start date
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hand Arm Bimanual Intensive Therapy Including Lower Extremities. HABIT..ILE 5hours/day, 5days/week 2 weeks HABIT-ILE is based on the principles of motor skill learning. It is built with structured activities/games involving intersegmental coordination of both upper and lower extremity and postural control of the trunk with progressive difficulties. Activities/games are child-friendly eliciting many repetitions of targeted activities in a motivational environment and oriented toward functional goals defined with children and their families. In the present study, activities are socio-culturally adapted ranging from: (1) table bimanual activities/games requiring intersegmental coordination, e.g., building with clay while sitting on fitness ball; (2) activities of daily living engaging both hands such as cooking activities using mortar and pestle. (3) gross motor activities/play engaging the upper, lower extremities and the trunk, e.g., rising from the ground with a car and make it run in a circuit from a table to the ground. Progressions during the therapy are implemented in two ways for each activity: increasing the complexity of activities by providing more unstable, or by submitting a more skillful activity. Whole and part tasks practice are used. Each child is under the responsibility of one or two HABIT-ILE trained interventionists who provided motivation, activities implementation, and avoided compensation. Interventionists must not touch the children to guide any movement. The therapy is “hands-off” except to prevent the child from falling. Children worked in a one-to-one with their interventionists but are engaged in group activities as well. The therapeutic/functional goals and the activities of the day are discussed during daily meetings in order to prepare the next day. Three trained supervisors will take on the whole organization of the camp and the coaching of the interventionists. A diary will be held to record activities provided to each child each day. [For more details about HABIT-ILE, see Bleyenheuft, Y., & Gordon, A. M. (2014). Hand-arm bimanual intensive 20
Control Group Usual Care 5hours/day; 5days/week 2 weeks The control group will benefit from the usual rehabilitation care currently provided to children in Benin. It is generally made of neurodevelopmental therapy, gross motor activities, stretching, passive mobilization, verticalization, etc. A diary will be held to record the care provided to each child each day in order to describe in more detail the contents of the therapy. 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children diagnosed with bilateral CP, Age from 2years old to under 5 years, GMFCS III & IV, MACS I - III, Able to follow instructions to complete the assessments. Severe vision impairments, Uncontrolled seizures, Enrolled in other treatments that might interfere for the last 6 months. Preschool Child: 2 Year-5 Year 24 Month(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 30/10/2019 Comite Ethique de la Recherche des Cliniques Universitaires de Medecine Physique et Readaptation du CNHU.HKM de Cotonou Benin
Ethics Committee Address
Street address City Postal code Country
Avenue Pape Jean-Paul II, 01 BP 386 Cotonou Cotonou 00229 Benin
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gross Motor Function Measure - GMFM-66, is a valid and reliable tool that measures changes in gross motor function in children with cerebral palsy. It includes five subdomains, Lying and rolling, sitting, crawling and kneeling, standing, and walking, running, jumping. It is video-recorded and scored off-site by a blinded assessor. Before treatment, immediately and six-weeks after treatment
Primary Outcome Both Hands Assessment - BoHA is a valid and reliable measure designed to assess how children with bilateral CP, MACS level I-III, aging from 18months to 12 years, engage both hands in bimanual activities performance. It is video-recorded and scored off-site by a blinded assessor. Before treatment, immediately and six-weeks after treatment
Secondary Outcome A culturally adapted version of ACTIVLIM-CP questionnaire, that measures the performance in daily life activities. in children with CP. The questionnaire is filled in by the parents of children. It is on the process of calibration. The experimental version will be used meanwhile. Before treatment, immediately and six-weeks after treatment
Secondary Outcome Canadian Occupational Performance Measure - COPM, it is a valid and reliable tool that helps in identifying functionals goals precious for children and parents in daily life. The children's performance and the parent's satisfaction are assessed to investigate changes in goals after therapy. Before treatment, immediately and six-weeks after treatment
Secondary Outcome Perception of cerebral palsy questionnaire, it aims at assessing the perception of cerebral palsy in parents of children with cerebral palsy in low-income countries of west-Africa. It includes items of knowledge of CP and its impact on social and family life. It is on the process of calibration. The experimental version will be used. Before treatment, immediately and six-weeks after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Community based rehabilitation centers and Rehabilitation department of National Teaching Hospital CNHUHKM Cotonou Cotonou Benin
Rehabilitation Service of Ste Elisabeth Hospital Calavi Calavi Benin
Rehabilitation Service of Departmental Hospital of GOHO Abomey Abomey Benin
Rehabilitation Service of Teaching Hospital of Department of Alibori Parakou Parakou Benin
FUNDING SOURCES
Name of source Street address City Postal code Country
Universite Catholique de Louvain. UCLouvain 01, Place de l.Universite Louvain la Neuve 1348 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cliniques Universitaires de Medecine Physique et Readaptation du CNHU.HKM de Cotonou. Avenue Pape Jean-Paul II, 01 BP 386 Cotonou Cotonou 00229 Benin Hospital
COLLABORATORS
Name Street address City Postal code Country
Yannick Bleyenheuft Avenue Mounier 53/B1.53.04 Woluwe Saint Lambert 1200 Belgium
Toussaint G. Kpadonou Avenue Pape Jean-Paul II, 01 BP 386 Cotonou Cotonou 00229 Benin
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emmanuel Sogbossi emmanuel.sogbossi@gmail.com +22995536383 Bohicon BP 170
City Postal code Country Position/Affiliation
Bohicon Benin PhD Student at UCLouvain
Role Name Email Phone Street address
Public Enquiries Emmanuel Sogbossi emmanuel.sogbossi@gmail.com 0022995536383 Bohicon BP 170
City Postal code Country Position/Affiliation
Bohicon Benin PhD Student at UCLouvain
Role Name Email Phone Street address
Scientific Enquiries Emmanuel Sogbossi emmanuel.sogbossi@gmail.com +22995536383 Bohicon, BP 170
City Postal code Country Position/Affiliation
Bohicon Benin PhD Student at UCLouvain
Role Name Email Phone Street address
Principal Investigator Yannick Bleyenheuft yannick.bleyenheuft@uclouvain.be +3227649349 Avenue Mounier 53/B1.53.04 1200 Woluwe
City Postal code Country Position/Affiliation
Woluwe 1200 Belgium Head of the Motor Kill Learning and Intensive Neurorehabiliatin Lab of the Institue of Neuroscience UCLouvain
Role Name Email Phone Street address
Scientific Enquiries Yannick Bleyenheuft yannick.bleyenheuft@uclouvain.be +3227649349 Avenue Mounier 53/B1.53.04 1200 Woluwe
City Postal code Country Position/Affiliation
woluwe 1200 Belgium Head of the Motor Kill Learning and Intensive Neurorehabiliatin Lab of the Institue of Neuroscience UCLouvain
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of IPD included in the protocol of the trial would be available after deidentification and publication of the study. Study Protocol IPD would be available after publication of the study and at any time. Researchers would have access to the IPD after justifying the scientific use of it and after the contributors of the trial agree on it.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information