Department of Nursing, Shantou University Medical College, 22 Xinling Road, Shantou, Guangdong Province, 515041, China.
The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong Province, 515041, China.
Trials. 2024 Aug 14;25(1):538. doi: 10.1186/s13063-024-08392-3.
Both individuals and society bear a considerable burden from ischemic stroke (IS), not only do patients continue suffering from motor dysfunction after discharge from hospital, but their caregivers also undertake the principal responsibility of assisting them in reintegrating into the family and society. To better improve the IS patients' limb function and daily life activities, their caregivers should also be involved in the training of the motor function rehabilitation during the period transitioning from hospital back home. This study mainly aims to investigate the effects of a nurse-led training for IS patients and their family caregivers on the improvement of the patients' physical function and the burden of caregivers.
METHODS/DESIGN: A randomized controlled trial with blind assessment will be conducted in hospitals and during the follow-ups at home. Fifty-eight pairs of adults diagnosed with ischemic stroke and their primary caregivers will be included. Participants will be randomly given with (1) a nurse-led, home-based motor rehabilitation training participated by caregivers (intervention group) or (2) routine self-care (control group). Both groups will receive assessment and health guidance on the day of discharge, and the intervention group will receive an additional home-based training program and supervision. These two groups will be followed up every week after discharge. The primary results are drawn from the evaluation of physical function and caregiver-related burden, and the secondary results derived from statistics of the modified Barthel index, stroke-specific quality of life, and National Institutes of Health Stroke Scale. Differences between the two groups will be measured by two-way repeated measures ANOVA, considering the data at baseline and at 1-week and 4-week follow-up after training.
Results may provide novel and valuable information on the effects of this culturally appropriate, caregiver-involved, and home-based rehabilitation training on the physical function of IS patients and caregiver-related burden.
Chinese Clinical Trial Registry (chictr.org.cn) ChiCTR2300078798. Registered on December 19, 2023.
缺血性脑卒中（IS）不仅给患者带来了身体上的残疾，使其在出院后仍持续遭受运动功能障碍的困扰，还给社会带来了沉重的负担。为了更好地提高 IS 患者的肢体功能和日常生活活动能力，他们的照顾者也应该参与到从医院回家后的运动功能康复训练中。本研究主要旨在探讨护士主导的 IS 患者及其家庭照顾者培训对改善患者身体功能和照顾者负担的效果。
方法/设计：将在医院和家庭随访期间进行一项随机对照试验，采用盲法评估。纳入 58 对确诊为缺血性脑卒中的成年患者及其主要照顾者。将参与者随机分为（1）照顾者参与的护士主导的家庭运动康复训练（干预组）或（2）常规自我护理（对照组）。两组患者在出院当天都会接受评估和健康指导，干预组还将接受额外的家庭训练计划和监督。两组患者在出院后每周进行一次随访。主要结果来自于身体功能和照顾者相关负担的评估，次要结果来自于改良巴氏指数、中风特异性生活质量和美国国立卫生研究院中风量表的统计。通过双向重复测量方差分析来测量两组之间的差异，同时考虑基线和训练后 1 周和 4 周的随访数据。
研究结果可能为这种文化上适宜、照顾者参与、家庭为基础的康复训练对 IS 患者身体功能和照顾者相关负担的影响提供新的、有价值的信息。
中国临床试验注册中心（chictr.org.cn），ChiCTR2300078798，于 2023 年 12 月 19 日注册。
