Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation

Официальное название

Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation for Elderly Patients Suffering From Arthritis and Fibromyalgia

Обзор

This study evaluates the effectiveness of wearable biofeedback devices in improving pain, mobility, and rehabilitation outcomes in elderly patients with arthritis and fibromyalgia in Karachi, Pakistan. In a randomized controlled trial involving 120 participants, one group will use biofeedback-integrated devices with guided exercises and virtual consultations, while the control group receives standard physiotherapy. The results will inform the potential of digital health solutions to improve accessibility and outcomes in remote rehabilitation for chronic pain management.

Подробное описание

Arthritis and fibromyalgia are common chronic musculoskeletal conditions among the elderly population, contributing to significant pain, reduced mobility, and diminished quality of life. In urban centers like Karachi, Pakistan, access to consistent and effective physiotherapy is often hindered by mobility limitations and inadequate healthcare infrastructure. This randomized controlled trial (RCT) investigates the efficacy of wearable biofeedback devices as an innovative approach to address these challenges.

A total of 120 elderly participants diagnosed with arthritis and/or fibromyalgia will be enrolled and randomized into two groups (60 participants per group). The intervention group will receive wearable biofeedback devices that monitor physiological parameters such as heart rate variability (HRV) and provide real-time feedback during guided home-based exercises, complemented by virtual physiotherapy consultations. The control group will follow standard physiotherapy exercise routines without biofeedback or virtual support.

Primary outcome measures include pain intensity (measured using a standardized pain scale), functional mobility (assessed via timed mobility tests), and joint range of motion. Secondary outcomes will assess heart rate variability, patient adherence to exercise protocols, and changes in psychological well-being.

This study seeks to determine whether wearable biofeedback can enhance rehabilitation outcomes, promote exercise adherence, and offer a viable, accessible alternative to conventional physiotherapy. If successful, the intervention could transform chronic pain management and rehabilitation strategies for aging populations, especially in resource-constrained urban environments.

Вмешательства

• Другое Wearable Biofeedback + Virtual Physiotherapy
  Participants will use wearable devices designed to monitor physiological parameters and provide real-time feedback during exercises. The intervention includes remote guidance from physiotherapists via virtual consultations.
• Другое Standard Physiotherapy Exercises
  Participants will be given printed or video instructions for standard physiotherapy exercises commonly used for arthritis and fibromyalgia management, without any digital monitoring or remote guidance.

Первичные конечные точки

• Pain Intensity (VAS Score) [Срок оценки: Baseline, Week 6, Week 12]
• Functional Mobility (Timed Up and Go Test) [Срок оценки: Baseline, Week 6, Week 12]
• Range of Motion (Goniometry) [Срок оценки: Baseline, Week 6, Week 12]

Вторичные конечные точки (5)

• Heart Rate Variability (HRV) [Срок оценки: Baseline, Week 6, Week 12]
• Patient Adherence [Срок оценки: Throughout the 12-week intervention]
• Change in Depression Severity (Beck Depression Inventory Score) [Срок оценки: Baseline, Week 12]
• System Usability and Patient Satisfaction [Срок оценки: Week 12]
• Change in Quality of Life (SF-36 Health Survey Score) [Срок оценки: Baseline, Week 12]

Критерии участия

Критерии включения

Elderly adults aged 60-80 years diagnosed with arthritis or fibromyalgia.

Experiencing moderate to severe pain and mobility limitations.

No recent surgical interventions or contraindications for physiotherapy.

Access to smartphones and internet connectivity for remote monitoring.

Критерии исключения

Patients with severe cognitive impairments affecting adherence to rehabilitation.

Presence of comorbidities that contraindicate physiotherapy (e.g., severe cardiac conditions).

Lack of access to digital devices required for remote monitoring.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• University of Karachi — Karachi

Публикации

• Akhter E, Bilal S, Kiani A, Haque U. Prevalence of arthritis in India and Pakistan: a review. Rheumatol Int. 2011 Jul;31(7):849-55. doi: 10.1007/s00296-011-1820-3. Epub 2011 Feb 18. PMID 21331574
• Dagnino APA, Campos MM. Chronic Pain in the Elderly: Mechanisms and Perspectives. Front Hum Neurosci. 2022 Mar 3;16:736688. doi: 10.3389/fnhum.2022.736688. eCollection 2022. PMID 35308613
• Danilin LK, Spindler M, Soros P, Bantel C. Heart rate and heart rate variability in patients with chronic inflammatory joint disease: the role of pain duration and the insular cortex. BMC Musculoskelet Disord. 2022 Jan 21;23(1):75. doi: 10.1186/s12891-022-05009-1. PMID 35062938
• Dudarev V, Barral O, Radaeva M, Davis G, Enns JT. Night time heart rate predicts next-day pain in fibromyalgia and primary back pain. Pain Rep. 2024 Feb 1;9(2):e1119. doi: 10.1097/PR9.0000000000001119. eCollection 2024 Apr. PMID 38322354

Идентификаторы

NCT: NCT06960330 · WBD-RPRAEF-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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