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