Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation

NCT06960330 | Not Yet Recruiting DMC

• 1 other identifier: WBD-RPRAEF-2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis; Fibromyalgia; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• 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).

  Baseline, Week 6, Week 12

• 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.

  Baseline, Week 6, Week 12

• 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).

  Baseline, Week 6, Week 12

Secondary Outcomes (5)

• 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Intervention Group

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.

Control Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Karachi: lead
• Advanced Education & Research Center: collaborator

Study Sites (1)

University of Karachi

Karachi, Sindh, 78500, Pakistan

Location

Related Publications (4)

• Akhter E, Bilal S, Kiani A, Haque U. Prevalence of arthritis in India and Pakistan: a review. Rheumatol Int. 2011 Jul;31(7):849-55. doi: 10.1007/s00296-011-1820-3. Epub 2011 Feb 18.

  PMID: 21331574 RESULT

• Dagnino APA, Campos MM. Chronic Pain in the Elderly: Mechanisms and Perspectives. Front Hum Neurosci. 2022 Mar 3;16:736688. doi: 10.3389/fnhum.2022.736688. eCollection 2022.

  PMID: 35308613 RESULT

• Danilin LK, Spindler M, Soros P, Bantel C. Heart rate and heart rate variability in patients with chronic inflammatory joint disease: the role of pain duration and the insular cortex. BMC Musculoskelet Disord. 2022 Jan 21;23(1):75. doi: 10.1186/s12891-022-05009-1.

  PMID: 35062938 RESULT

• Dudarev V, Barral O, Radaeva M, Davis G, Enns JT. Night time heart rate predicts next-day pain in fibromyalgia and primary back pain. Pain Rep. 2024 Feb 1;9(2):e1119. doi: 10.1097/PR9.0000000000001119. eCollection 2024 Apr.

  PMID: 38322354 RESULT

MeSH Terms

Conditions

Arthritis; Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Basit Ansari, Ph.D.

  University of Karachi

  STUDY DIRECTOR

Central Study Contacts

Shamoon Noushad, Ph.D.

CONTACT

03333549258; shamoon@aeirc-edu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2025
• First Posted: May 7, 2025
• Study Start: May 6, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)