Independent Researcher, Johannesburg, South Africa.
Department of Occupational Therapy, Mulago National Referral Hospital, Kampala, Uganda.
BMJ Open. 2021 Mar 8;11(3):e047634. doi: 10.1136/bmjopen-2020-047634.
Cerebral palsy (CP) is the most common childhood-onset motor disorder accompanied by associated impairments, placing a heavy burden on families and health systems. Most children with CP live in low/middle-income countries with little access to rehabilitation services. This study will evaluate the Akwenda CP programme, a multidimensional intervention designed for low-resource settings and aiming at improving: (1) participation, motor function and daily activities for children with CP; (2) quality of life, stress and knowledge for caregivers; and (3) knowledge and attitudes towards children with CP in the communities.
This quasi-randomised controlled clinical study will recruit children and youth with CP aged 2-23 years in a rural area of Uganda. Children will be allocated to one of two groups with at least 44 children in each group. Groups will be matched for age, sex and motor impairment. The intervention arm will receive a comprehensive, multidimensional programme over a period of 11 months comprising (1) caregiver-led training workshops, (2) therapist-led practical group sessions, (3) provision of technical assistive devices, (4) goal-directed training and (5) community communication and advocacy. The other group will receive usual care. The outcome of the intervention will be assessed before and after the intervention and will be measured at three levels: (1) child, (2) caregiver and (3) community. Standard analysis methods for randomised controlled trial will be used to compare groups. Retention of effects will be examined at 12-month follow-up.
The study has been approved by the Uganda National Council for Science and Technology (SS 5173) and registered in accordance with WHO and ICMJE standards. Written informed consent will be obtained from caregivers. Results will be disseminated among participants and stakeholders through public engagement events, scientific reports and conference presentations.
Pan African Clinical Trials Registry (PACTR202011738099314) Pre-results.
脑瘫（CP）是最常见的儿童期起病的运动障碍，伴有相关的损伤，给家庭和医疗系统带来沉重负担。大多数脑瘫患儿生活在中低收入国家，很少有机会获得康复服务。这项研究将评估阿克温达 CP 项目，这是一种为资源有限环境设计的多维干预措施，旨在改善：（1）患儿的参与度、运动功能和日常活动；（2）照顾者的生活质量、压力和知识；（3）社区对脑瘫患儿的认知和态度。
这是一项在乌干达农村地区进行的准随机对照临床试验，将招募 2-23 岁的脑瘫儿童和青少年。将患儿分为两组，每组至少 44 名。两组将按年龄、性别和运动障碍进行匹配。干预组将接受为期 11 个月的全面多维方案，包括（1）照顾者主导的培训研讨会，（2）治疗师主导的实践小组会议，（3）提供技术辅助设备，（4）目标导向训练，以及（5）社区沟通和宣传。另一组将接受常规护理。干预的结果将在干预前后进行评估，并将在三个层面进行测量：（1）患儿，（2）照顾者，（3）社区。将采用随机对照试验的标准分析方法比较两组。在 12 个月的随访中，将检查效果的保持情况。
该研究已获得乌干达科学技术委员会的批准（SS 5173），并按照世卫组织和 ICMJE 标准进行了注册。将获得照顾者的书面知情同意。通过公众参与活动、科学报告和会议演讲，将在参与者和利益攸关方中传播研究结果。
泛非临床试验注册中心（PACTR202011738099314）预注册。
