Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation

April 28, 2025 updated by: Shamoon Noushad, University of Karachi

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 78500
        • University of Karachi
        • Contact:
          • Muhammad Jabbar, M.Phil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

Participants in this group will receive wearable biofeedback devices integrated with guided exercise routines and virtual physiotherapy consultations over a set period (e.g., 12 weeks). The devices will provide real-time physiological monitoring and feedback, including heart rate variability (HRV), to guide home-based rehabilitation.

Intervention Name:

Wearable Biofeedback + Virtual Physiotherapy

Intervention Type:

Device (or Behavioral, depending on how the registry classifies it)

Intervention Description:

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.
Other: 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.
Active Comparator: Control Group

Participants in this group will perform a standard physiotherapy exercise regimen without any wearable biofeedback device or virtual consultation support.

Intervention Name:

Standard Physiotherapy Exercises

Intervention Type:

Behavioral

Intervention Description:

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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Week 6, Week 12
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.
Baseline, Week 6, Week 12
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).
Baseline, Week 6, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 6, Week 12
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.
Throughout the 12-week intervention
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.
Baseline, Week 12
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.
Week 12
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.
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Karachi

Collaborators

Advanced Education & Research Center

Investigators

  • Study Director: Basit Ansari, Ph.D., University of Karachi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 6, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

April 19, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 7, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

April 28, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WBD-RPRAEF-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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