Pandian Jeyaraj D, Felix Cynthia, Kaur Paramdeep, Sharma Deepika, Julia Lizzie, Toor Gagan, Arora Rajni, Gandhi Dorcas B C, Verma Shweta J, Anderson Craig S, Langhorne Peter, Murthy G V S, Hackett Maree L, Maulik Pallab K, Alim Mohammed, Harvey Lisa A, Jan Stephen, Walker Marion, Forster Anne, Lindley Richard
Stroke Unit, Department of Neurology, Christian Medical College, Ludhiana, Punjab, India.
Department of Physiotherapy, Christian Medical College, Ludhiana, Punjab, India.
Int J Stroke. 2015 Jun;10(4):609-14. doi: 10.1111/ijs.12475. Epub 2015 Mar 9.
The aim of this pilot study was to determine the feasibility of a multicenter, randomized, controlled trial in India of a family-led, trained caregiver-delivered, home-based rehabilitation intervention vs. routine care.
A prospective, randomized (within seven-days of hospital admission), blinded outcome assessor, controlled trial of structured home-based rehabilitation delivered by trained and protocol-guided family caregivers (intervention) vs. routine care alone (control) was conducted in patients with residual disability. Key feasibility measures were recruitment, acceptance and adherence to assessment procedures, and follow-up of participants over six-months. CTRI/2014/10/005133.
A total of 104 patients from the stroke unit at Christian Medical College, Ludhiana were recruited over nine-months. Recruitment was feasible and accepted by patients and their carers. Important observations were made regarding potential unblinding of the participants, contamination of therapy between the randomized groups, organization of home visits, and resources required for a multicenter study.
The pilot study established the feasibility of conducting a large-scale study of family-led, trained caregiver-delivered, home-based stroke rehabilitation in a low resource setting. The main phase of the trial 'ATTEND' is currently underway in over 10 centers in India.
本试点研究的目的是确定在印度开展一项多中心、随机对照试验的可行性，该试验旨在比较由家庭主导、经过培训的护理人员提供的居家康复干预措施与常规护理。
对有残留残疾的患者进行了一项前瞻性、随机（入院七天内）、结果评估者盲法的对照试验，比较由经过培训且遵循方案指导的家庭护理人员提供的结构化居家康复（干预组）与单纯常规护理（对照组）。关键的可行性指标包括招募情况、对评估程序的接受度和依从性，以及对参与者进行为期六个月的随访。CTRI/2014/10/005133。
在九个月的时间里，共招募了来自卢迪亚纳基督教医学院卒中单元的104名患者。招募工作是可行的，患者及其护理人员也予以接受。针对参与者可能的非盲法、随机分组之间治疗的交叉污染、家访的组织以及多中心研究所需的资源等方面进行了重要观察。
该试点研究证实了在资源匮乏环境下开展一项关于家庭主导、由经过培训的护理人员提供的居家卒中康复的大规模研究的可行性。试验的主要阶段“ATTEND”目前正在印度的10多个中心进行。
