Clinical trial NCT06960330: Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation
Official title: Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation for Elderly Patients Suffering From Arthritis and Fibromyalgia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthritis
Fibromyalgia
Chronic Pain
Lead sponsor: University of Karachi
Sponsor class: OTHER
Collaborators: name: Advanced Education & Research Center
First posted: 2025-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity (VAS Score)
timeFrame: Baseline, Week 6, Week 12
measure: Functional Mobility (Timed Up and Go Test)
timeFrame: Baseline, Week 6, Week 12
measure: Range of Motion (Goniometry)
timeFrame: Baseline, Week 6, Week 12
Secondary outcomes:
measure: Heart Rate Variability (HRV)
timeFrame: Baseline, Week 6, Week 12
measure: Patient Adherence
timeFrame: Throughout the 12-week intervention
measure: Change in Depression Severity (Beck Depression Inventory Score)
timeFrame: Baseline, Week 12
measure: System Usability and Patient Satisfaction
timeFrame: Week 12
measure: Change in Quality of Life (SF-36 Health Survey Score)
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: University of Karachi
state: Sindh
Study officials:
affiliation: University of Karachi
name: Basit Ansari, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.