Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-06

Study Completion Date

2028-02-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Arthritis Fibromyalgia Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomized into two parallel groups:

Intervention Group - receives wearable biofeedback devices with guided exercises and virtual physiotherapy.

Control Group - receives standard physiotherapy exercises without biofeedback.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Wearable Biofeedback + Virtual Physiotherapy

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Standard Physiotherapy Exercises

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No