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| Name | Class |
|---|---|
| Advanced Education & Research Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 6, Week 12 |
| Patient Adherence |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shamoon Noushad, Ph.D. | Contact | 03333549258 | shamoon@aeirc-edu.com |
| Name | Affiliation | Role |
|---|---|---|
| Basit Ansari, Ph.D. | University of Karachi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Karachi | Karachi | Sindh | 78500 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21331574 | Result | 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. | |
| 35308613 | 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. |
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| ID | Term |
|---|---|
| D001168 | Arthritis |
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009135 | Muscular Diseases |
| D012216 | Rheumatic Diseases |
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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.
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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.
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| 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. |
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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) | The BDI score ranges from 0 to 63. Higher scores indicate more severe depressive symptoms. | Baseline, Week 12 |
| 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. | Week 12 |
| Change in Quality of Life (SF-36 Health Survey Score) | The SF-36 consists of 8 scaled scores (0-100). Higher scores indicate better health status. | Baseline, Week 12 |
| 35062938 | 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. |
| 38322354 | 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. |
| D009468 |
| Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |