An interventional study of Wearable Biofeedback + Virtual Physiotherapy and Standard Physiotherapy Exercises in Arthritis, Fibromyalgia and Chronic Pain, sponsored by University of Karachi. Enrolling by invitation at 1 site in Pakistan. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of Karachi · Not applicable, Interventional, and Treatment
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 chronic musculoskeletal conditions that contribute to persistent pain, functional limitations, reduced mobility, and impaired quality of life among older adults. Access to consistent physiotherapy may be challenging in Karachi, Pakistan, particularly for individuals experiencing mobility restrictions, transportation difficulties, financial limitations, and barriers to regular healthcare access. Wearable biofeedback technology may offer an accessible approach to supporting individualized, home-based rehabilitation.
This study is designed as an eight-week, single-blind (outcome-assessor-blinded), two-arm, parallel-group randomized controlled trial to evaluate the effectiveness of wearable biofeedback-supported remote physiotherapy compared with standard home-based physiotherapy among adults aged 60-80 years diagnosed with arthritis or fibromyalgia.
A total of 120 eligible participants will be recruited and randomly allocated in a 1:1 ratio to an intervention group (n=60) or control group (n=60). Randomization will be stratified according to baseline pain intensity (Visual Analogue Scale [VAS] 4-6 versus 7-10) and functional mobility (Timed Up and Go [TUG] test \<13.5 seconds versus ≥13.5 seconds). A computer-generated random allocation sequence with randomly varying block sizes will be used, with allocation concealed until enrollment and baseline assessment are completed.
Participants in the intervention group will receive individualized home-based physiotherapy supported by wearable biofeedback devices providing real-time physiological and movement-related feedback. The exercise program will be tailored according to pain severity, mobility limitations, range of motion, and clinical presentation. Weekly remote physiotherapy consultations will support exercise progression, symptom monitoring, adherence, and patient safety.
Participants in the control group will receive individualized home-based physiotherapy without wearable biofeedback support. They will follow prescribed exercise routines supported by educational materials and prerecorded instructional videos, with remote physiotherapy consultations conducted every two weeks. Both treatment groups will participate in the intervention for eight weeks.
Outcome assessments will be performed at baseline (week 0), mid-intervention (week 4), and post-intervention (week 8). The single primary outcome will be pain intensity measured using the VAS, with the principal treatment comparison performed at week 8 after adjustment for baseline pain intensity. Secondary outcomes will include functional mobility, joint range of motion, heart rate variability, exercise adherence, psychological well-being, health-related quality of life, and intervention usability and satisfaction.
The statistical analysis will follow the intention-to-treat principle. Linear mixed-effects models will be used to evaluate longitudinal treatment effects and account for correlations between repeated observations. The primary treatment effect will be reported as the baseline-adjusted between-group difference in pain intensity at week 8, together with its 95% confidence interval. Missing-data patterns will be documented, and appropriate sensitivity analyses will be conducted.
The study aims to determine whether wearable biofeedback-supported remote rehabilitation provides additional benefits in pain management, functional mobility, and rehabilitation adherence compared with standard home-based physiotherapy. The findings may inform future development of accessible technology-assisted rehabilitation approaches for older adults in resource-constrained healthcare settings.
843 studies on the registry are indexed under Arthritis; 118 are open to participants now.
This study's planned enrollment of 120 is above the median of 97 across 599 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of Karachi is the lead sponsor of 37 studies on the registry; 9 are open to participants now.
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Elderly adults aged 60-80 years diagnosed with arthritis or fibromyalgia.
Experiencing moderate to severe pain and mobility limitations.
No recent surgical interventions or 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive individualized home-based physiotherapy supported by wearable biofeedback devices providing real-time feedback. Exercise plans will be tailored according to pain intensity, functional mobility, range of motion, and clinical presentation. Weekly remote physiotherapy consultations will support monitoring, adherence, and exercise progression. The intervention will last eight weeks.
Other: Wearable Biofeedback + Virtual Physiotherapy
Participants will receive individualized home-based physiotherapy without wearable biofeedback devices. Exercise plans will be tailored according to baseline clinical assessments. Participants will receive exercise manuals and prerecorded instructional materials, with remote physiotherapy consultations conducted every two weeks. The intervention will last eight weeks.
Other: Standard Physiotherapy Exercises
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.
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.
Pain Intensity Measured Using the Visual Analogue Scale (VAS) at Week 8
Pain intensity will be assessed using a 10-cm Visual Analogue Scale (VAS), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. Assessments will be conducted at baseline, week 4, and week 8. The primary treatment effect will be the baseline-adjusted between-group difference in pain intensity at week 8.
Time frame: Baseline, Week 4, and Week 8 (primary endpoint at Week 8).
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
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
Functional Mobility (Timed Up and Go Test)
Functional mobility will be assessed using the Timed Up and Go (TUG) test. The time required to rise from a chair, walk 3 meters, turn, return, and sit down will be recorded in seconds. Lower times indicate better performance.
Time frame: Baseline, Week 4, Week 8
Joint Range of Motion (Goniometry)
Joint range of motion will be assessed using standardized goniometric measurements of prespecified affected joints. Measurements will be recorded in degrees to evaluate changes in joint mobility during rehabilitation.
Time frame: Baseline, Week 4, Week 8
Heart Rate Variability (HRV)
Heart rate variability will be evaluated using time-domain measures, including the root mean square of successive differences (RMSSD), and frequency-domain measures, including the low-frequency/high-frequency (LF/HF) ratio.
Time frame: Baseline, Week 4, Week 8
Exercise Adherence
Adherence to prescribed home-based physiotherapy will be evaluated using available application or wearable usage logs and physiotherapist monitoring records, documenting participants' engagement with prescribed exercise sessions.
Time frame: Baseline, Week 4, Week 8
Change in Depression Severity (Beck Depression Inventory)
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), with scores ranging from 0 to 63. Higher scores indicate greater depressive symptom severity.
Time frame: Baseline, Week 4, Week 8
Device Usability (System Usability Scale)
Usability of the wearable biofeedback system will be assessed using the 10-item System Usability Scale (SUS). Scores range from 0 to 100, with higher scores indicating better perceived usability. This outcome applies to participants using the wearable device.
Time frame: Week 8
Change in Health-Related Quality of Life (SF-36)
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36), covering eight health domains. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: Baseline, Week 4, Week 8
Patient Satisfaction With Remote Rehabilitation
Measure Description: Participant satisfaction with the assigned rehabilitation program will be assessed at the end of the eight-week intervention using the prespecified participant satisfaction questionnaire.
Time frame: Week 8.
Plan to share: No
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University of Karachi