Health TrialsbyHealthPanel

Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation

ConditionsArthritisFibromyalgiaChronic Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorUniversity of Karachi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Wearable Biofeedback + Virtual Physiotherapy

    Other intervention

    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 intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Intensity (VAS Score)

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).

Time frame
Baseline, Week 6, Week 12
2

Functional Mobility (Timed Up and Go Test)

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.

Time frame
Baseline, Week 6, Week 12
3

Range of Motion (Goniometry)

Joint range of motion will be measured using a goniometer to assess changes in movement capacity of affected joints (e.g., knees, shoulders).

Time frame
Baseline, Week 6, Week 12

Secondary outcomes

1

Heart Rate Variability (HRV)

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

Time frame
Baseline, Week 6, Week 12
2

Patient Adherence

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

Time frame
Throughout the 12-week intervention
3

Change in Depression Severity (Beck Depression Inventory Score)

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

Time frame
Baseline, Week 12
4

System Usability and Patient Satisfaction

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.

Time frame
Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Karachi

Lead sponsor

Advanced Education & Research Center

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: