Sustainable Model of eARly Intervention and Tele-rehabilitation for children with Cerebral Palsy in rural Bangladesh (SMART CP) – a cluster randomized controlled trial

This study will have two arms; one intervention arm (SMART CP model) and one control arm (care-as usual). The SMART CP model has been developed based on literature findings. Intervention: The SMART CP model will have three components a. Referral networks with Key Informants (KIs) and mPower (Mothers Power) groups b. SMART CP centre c. tele-rehabilitation service. The intervention will be provided over 12 months. 1. At village level-Primary Referral Network: a. Key Informant (KIs): As part of the trial, local community volunteers (e.g. religious leaders, teachers, community health workers etc.) will be trained as KIs to identify children with CP from their community and act as a source of ongoing advocacy and referral. Led by CMs, the KIs will receive a day-long (5-6 hours) face-to-face workshop on the identification of children with suspected CP, disability sensitization, advocacy for a disability-inclusive society using flip charts, group work and role-play. Considering 1-2 KIs per village, this study will train around 1150 KIs. KIs will continue to screen for children with suspected CP and refer those children to sub-district level centre (i.e. SMART CP centre) over the trial period (12 months). b. mPower (Mothers Power) groups: Each mPower group will be formed with 10 mothers of children with CP. These groups will meet on a weekly basis for 60 minutes to share information and experiences. The network will empower mothers/primary caregivers by enriching their knowledge about CP so that they can advocate for their child and facilitate the child’s participation at home, community, school and vocation. As part of this study, 48 mPower groups will be formed. The mPower group meetings will be arranged weekly over 12 months of the trial. 2. Sub-district level (SMART CP centre)– As part of the referral networks a sub-district level early diagnosis, early intervention and tele-rehabilitation service centre for children with CP will be established. Known as SMART CP centre, each facility will be equipped with basic physiotherapy equipment and staffed by a Diploma Physiotherapist (DP), a Community Rehabilitation Worker (CRW) and a Community Mobilizer (CM). The CRWs and CMs will be recruited locally and trained on early intervention protocol. Services at the centres will be made available for all children with CP at a nominal cost to make it sustainable. However, the cost of service will be waived up to 100% considering financial status of families of children with CP. Each child recruited in the intervention arm will receive a 60-munites Goal Directed Training (GDT) session weekly at the SMART CP centres over 12 months. GDT is an activity-focused, goal-oriented and parents-led intervention. There will be four components of GDT; (1) Goal selection: The GDT session will start with realistic and appropriately time-framed goals set up in collaboration with parents. Goals are basically some specific tasks that are needed for everyday life and which children with CP find challenging. These tasks could be gross motor, self-care, communication, play or school-based activities. (2) Assessment: A detailed assessment will then be carried out to identify facilitating and limiting factors in achieving the goals. This will involve assessing the physical requirements of the selected task, the resources and equipment that are needed, and the settings in which the task is done. (3) Intervention: Weekly GDT sessions will be conducted by CRWs under the supervision of DPs. The CRWs will guide parents/primary caregivers to scaffold the selected motor tasks so that the child could actively complete at least a part of the task. Parents will be encouraged to use their knowledge of their child’s play preferences to elicit self-generated motor activity. Additionally, the CMs will also assist parents to set up a motor-enriched play environment at home to promote the child’s self-generated movements, exploration, and task success during monthly home visits. Parents will be advised to practice through joyful play until the main goal is achieved. (4) Outcome evaluation: CRWs will evaluate the adherence and compliance to the intervention by using attendance registers, checklists and probing questions (e.g. asking to demonstrate the interventions that s/he administered in last week) during GDT sessions and monthly home visits (by CMs). The extent to which a child’s goals are achieved will be monitored and recorded using a structured template. 3. Tele-rehabilitation- The SMART CP centres will be supported by a centralised tele-rehabilitation team including a trained Doctor, a Physiotherapist, a Speech Therapist and a Nutritionist. Each child recruited in the trial will receive a 30-minutes tele-rehabilitation session fortnightly over 12 months. The tele-rehabilitation team will oversee the services and interventions provided at the SMART CP centres and monitor the progression of interventions and outcomes. The first tele-rehabilitation session will be comprised of clinical assessment, goals setting and rehabilitation plan development for each child recruited in the trial. In the subsequent tele-rehabilitation sessions, the team will evaluate treatment progress and child’s goal attainments, make necessary amendments to the existing rehabilitation and guide DPs and CRWs to facilitate GDT.