Supplementary Material for: Ayurvedic Treatment in the Rehabilitation of Ischemic Stroke Patients in India: A Randomized Controlled Trial (RESTORE) – Findings from the Process Evaluation

Introduction: The RESTORE trial was the first randomized controlled trial comparing two systems of medicine in stroke. The trial studied about the safety and efficacy of ayurvedic rehabilitative treatment in comparison with conventional physiotherapy in stroke rehabilitation across North and South India. The results showed that ayurvedic rehabilitative treatment was not superior to conventional physiotherapy for improving sensorimotor recovery in ischemic stroke patients, but it was safe to use. The process evaluation assessed the implementation of the trial and its specific rehabilitation effects.

Methods: A mixed methods approach, incorporating qualitative in-depth interviews and quantitative data derived from case report forms and activity logs, was employed. Thirty-eight interviews of patient-caregiver dyads and health professionals were conducted. Thematic analysis of qualitative data was done with RE-AIM and realist models. The process evaluation aimed to evaluate the reach, effectiveness, adoption, implementation, and maintenance of the RESTORE trial through the RE-AIM model. The context-mechanism-outcome (CMO) configuration was used as the main structure for realist analysis.

Results: Participants in the intervention (ayurvedic rehabilitative treatment) and control (physiotherapy) groups experienced advantages from the therapy, like improved mobility. In addition, the intervention group reported enhanced emotional stability and pain relief compared to the control group. Participants, particularly from South India, found ayurveda therapies more acceptable. In this study, three key reasons were identified for ayurvedic rehabilitative therapy not outperforming conventional physiotherapy. First, a standard ayurveda treatment protocol may not suit every patient, as ayurveda emphasizes individualized care. Second, certain treatments like nasya were excluded due to safety concerns for stroke patients, likely affecting outcomes. Lastly, a one-month duration of ayurveda treatment may be too short to enhance stroke recovery.

Conclusion: This process evaluation suggests the need for further studies with a revised protocol that may lead to an important step in integrating ayurveda and physiotherapy in stroke rehabilitation in India.

Trial Registration: The RESTORE trial was registered under the Clinical Trials Registry – India (https://ctri.nic.in/Clinicaltrials/) with the registration ID - CTRI/2018/04/013379 dated 19/04/2018

引言：RESTORE试验是首个比较两种医学体系在中风治疗中的随机对照试验（randomized controlled trial）。该试验在印度南北地区开展，旨在研究阿育吠陀康复治疗（Ayurvedic rehabilitative treatment）与传统物理治疗在中风康复中的安全性和有效性。结果显示，阿育吠陀康复治疗在改善缺血性中风患者（ischemic stroke patients）的感觉运动恢复方面并不优于传统物理治疗，但使用安全。过程评估则对试验的实施及其具体康复效果进行了评估。

方法：采用混合方法学（mixed methods approach），整合定性深度访谈（qualitative in-depth interviews）及来自病例报告表（case report forms）和活动日志（activity logs）的定量数据。共对38组患者-照护者配对（patient-caregiver dyads）和卫生专业人员进行了访谈。采用RE-AIM模型和现实主义模型（realist models）对定性数据进行主题分析（thematic analysis）。过程评估通过RE-AIM模型评估RESTORE试验的覆盖范围、有效性、采纳度、实施情况及维持性；背景-机制-结果（CMO）构型被用作现实主义分析的核心框架。

结果：干预组（阿育吠陀康复治疗）和对照组（传统物理治疗）的参与者均从治疗中获益，例如活动能力（mobility）改善。此外，与对照组相比，干预组报告了情绪稳定性（emotional stability）增强和疼痛缓解（pain relief）。尤其来自印度南部的参与者更易接受阿育吠陀疗法。本研究确定了阿育吠陀康复治疗未优于传统物理治疗的三个关键原因：其一，标准阿育吠陀治疗方案（standard Ayurveda treatment protocol）可能不适用于所有患者，因阿育吠陀强调个体化护理（individualized care）；其二，出于中风患者安全考虑，某些治疗（如纳斯亚疗法（Nasya））被排除，这可能影响了结果；其三，一个月的阿育吠陀治疗时长可能过短，不足以促进中风恢复。

结论：本过程评估表明，需进一步开展采用修订方案的研究，这或将成为印度中风康复领域整合阿育吠陀与物理治疗的重要一步。

试验注册：RESTORE试验已在印度临床试验注册库（https://ctri.nic.in/Clinicaltrials/）注册，注册号为CTRI/2018/04/013379，注册日期为2018年4月19日