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NCT Number: NCT06960330

Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation

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.

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Key information

Conditions

Arthritis Chronic Pain Fibromyalgia Joint Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Karachi

Karachi, Sindh, 78500, Pakistan

Location contact

Muhammad Jabbar, M.Phil

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Wearable Biofeedback + Virtual Physiotherapy

Other

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.

Standard Physiotherapy Exercises

Other

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.

Primary outcomes

  1. Pain Intensity (VAS Score)

    Time frame: 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).

  2. Functional Mobility (Timed Up and Go Test)

    Time frame: 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.

  3. Range of Motion (Goniometry)

    Time frame: 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).

Secondary outcomes

  1. Heart Rate Variability (HRV)

    Time frame: Baseline, Week 6, Week 12

    HRV will be evaluated using time-domain (e.g., RMSSD) and frequency-domain (e.g., LF/HF ratio) metrics recorded by wearable devices.

  2. Patient Adherence

    Time frame: Throughout the 12-week intervention

    Adherence to prescribed exercises will be monitored through device usage logs, measuring frequency and duration of engagement with the intervention.

  3. Change in Depression Severity (Beck Depression Inventory Score)

    Time frame: Baseline, Week 12

    The BDI score ranges from 0 to 63. Higher scores indicate more severe depressive symptoms.

  4. System Usability and Patient Satisfaction

    Time frame: Week 12

    The SUS consists of 10 items, each rated on a 5-point Likert scale (from Strongly Agree to Strongly Disagree). The total score ranges from 0 to 100. A higher score indicates better usability and user satisfaction.

  5. Change in Quality of Life (SF-36 Health Survey Score)

    Time frame: Baseline, Week 12

    The SF-36 consists of 8 scaled scores (0-100). Higher scores indicate better health status.

Study contacts

Contact information is provided by the study sponsor or research team.

Shamoon Noushad, Ph.D.

CONTACT

[email protected]

03333549258

Sponsors and collaborators

Lead sponsor

University of Karachi

Other

Collaborators

  • Advanced Education & Research Center

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 7, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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