Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation for Elderly Patients Suffering From Arthritis and Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Pain Intensity (VAS Score)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Due to the nature of the intervention (wearable devices and virtual consultations), blinding of participants and care providers is not feasible. This is an open-label study.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Pain Intensity (VAS Score)
时间窗: Baseline, Week 6, Week 12
Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-cm horizontal line where participants mark their perceived pain level from 0 (no pain) to 10 (worst imaginable pain).
Functional Mobility (Timed Up and Go Test)
时间窗: Baseline, Week 6, Week 12
Functional mobility will be assessed using the Timed Up and Go (TUG) Test. Participants will be timed as they rise from a chair, walk 3 meters, turn, return, and sit down again.
Range of Motion (Goniometry)
时间窗: Baseline, Week 6, Week 12
Joint range of motion will be measured using a goniometer to assess changes in movement capacity of affected joints (e.g., knees, shoulders).
次要结局
- Heart Rate Variability (HRV)(Baseline, Week 6, Week 12)
- Patient Adherence(Throughout the 12-week intervention)
- Change in Depression Severity (Beck Depression Inventory Score)(Baseline, Week 12)
- System Usability and Patient Satisfaction(Week 12)
- Change in Quality of Life (SF-36 Health Survey Score)(Baseline, Week 12)
研究者
Shamoon Noushad
Professor
University of Karachi