Wearable biofeedback devices for remote rehabilitation of elderly patients with arthritis and fibromyalgia: a randomized controlled trial protocol

Arthritis and fibromyalgia are prevalent chronic conditions among elderly individuals, significantly impairing mobility, pain management, and overall well-being. Traditional physiotherapy is often inaccessible due to mobility constraints, high costs, and limited healthcare facilities, particularly in resource-limited urban centers like Karachi, Pakistan. Wearable biofeedback devices provide real-time physiological monitoring and feedback, enabling home-based, personalized rehabilitation. This protocol describes a randomized controlled trial (RCT) designed to evaluate the effectiveness of wearable biofeedback devices in improving pain management, functional mobility, and rehabilitation outcomes among elderly patients with arthritis and fibromyalgia. This single-blind, parallel-group randomized controlled trial will enroll 120 adults aged 60–80 years with arthritis or fibromyalgia (60 per group). Over 8 weeks, the intervention group will receive wearable biofeedback-assisted home physiotherapy with weekly remote consultations, while controls will receive standard home physiotherapy with biweekly consultations. Assessments will occur at baseline, week 4, and week 8. The primary outcome will be VAS pain intensity at week 8, adjusted for baseline values. Secondary outcomes will include functional mobility, range of motion, heart rate variability, exercise adherence, psychological well-being, quality of life, device usability, and satisfaction. Longitudinal data will be analyzed using mixed-effects models following the intention-to-treat principle. Expected Results This study will generate evidence on the feasibility and potential benefits of wearable-assisted rehabilitation for elderly populations. The trial will also provide insight into cost-effectiveness, usability, and accessibility in resource-constrained contexts. This protocol will address the impact of wearable biofeedback in remote physiotherapy, aiming to evaluate its effectiveness in enhancing pain management, functional recovery, and accessibility for elderly individuals with arthritis and fibromyalgia. The findings are expected to inform future implementation of technology-assisted rehabilitation in resource-limited settings. ClinicalTrials.gov NCT06960330. Registration on April 19, 2025. Version Date: 21 July 2026.