ArthritisNCT06960330
Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation
A study testing Wearable Biofeedback + Virtual Physiotherapy and Standard Physiotherapy Exercises in people with Arthritis and Fibromyalgia, run by University of Karachi at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Arthritis, Fibromyalgia, Chronic Pain
- What is being tested?
- Wearable Biofeedback + Virtual Physiotherapy and Standard Physiotherapy Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation for Elderly Patients Suffering From Arthritis and Fibromyalgia
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.
Read the detailed description
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.
- Conditions
- Arthritis, Fibromyalgia, Chronic Pain
- Being tested
- Wearable Biofeedback + Virtual Physiotherapy, Standard Physiotherapy Exercises
- Medical subject headings
- Arthritis, Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Biofeedback + Virtual PhysiotherapyOther
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.
Standard Physiotherapy ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Wearable Biofeedback + Virtual Physiotherapy |
| Control Group | Active comparator | 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. Receives: Other: Standard Physiotherapy Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Baseline, Week 6, Week 12
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Education & Research Center
- Responsible party
- Principal investigator, Shamoon Noushad, University of Karachi
- Investigators
- Basit Ansari, Ph.D., Study director, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960330
- Sponsor's protocol ID
- WBD-RPRAEF-2025
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21331574Dagnino 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.
PubMed 35308613Danilin 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.
PubMed 35062938Dudarev 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.
PubMed 38322354
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation for Elderly Patients Suffering From Arthritis and Fibromyalgia
- ClinicalTrials.gov ID
- NCT06960330
- Acronym / sponsor ID
- WBD-RPRAEF-2025
- Conditions
- Arthritis, Fibromyalgia, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Advanced Education & Research Center
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Wearable Biofeedback + Virtual PhysiotherapyParticipants 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. |
| Control Group | Active comparator | Other: Standard Physiotherapy ExercisesParticipants 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. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Biofeedback + Virtual PhysiotherapyParticipants 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 | Intervention Group |
| Standard Physiotherapy ExercisesParticipants 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 | Control Group |
Primary outcome
Pain Intensity Measured Using the Visual Analogue Scale (VAS) at Week 8
Time frame: Baseline, Week 4, and Week 8 (primary endpoint 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.
Functional Mobility (Timed Up and Go Test)
Time frame: Baseline, Week 6, Week 12
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.
Range of Motion (Goniometry)
Time frame: Baseline, Week 6, Week 12
Joint range of motion will be measured using a goniometer to assess changes in movement capacity of affected joints (e.g., knees, shoulders).
7 secondary outcomes
Functional Mobility (Timed Up and Go Test)
Time frame: Baseline, Week 4, Week 8
Joint Range of Motion (Goniometry)
Time frame: Baseline, Week 4, Week 8
Heart Rate Variability (HRV)
Time frame: Baseline, Week 4, Week 8
Exercise Adherence
Time frame: Baseline, Week 4, Week 8
Change in Depression Severity (Beck Depression Inventory)
Time frame: Baseline, Week 4, Week 8
Device Usability (System Usability Scale)
Time frame: Week 8
Change in Health-Related Quality of Life (SF-36)
Time frame: Baseline, Week 4, Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Results publication: PubMed 21331574Akhter 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.
- Results publication: PubMed 35308613Dagnino 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.
- Results publication: PubMed 35062938Danilin 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.
- Results publication: PubMed 38322354Dudarev 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Basit Ansari, Ph.D. study director
University of Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Biofeedback + Virtual Physiotherapy and Standard Physiotherapy Exercises in people with Arthritis and Fibromyalgia, run by University of Karachi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Measured Using the Visual Analogue Scale (VAS) at Week 8 (time frame: Baseline, Week 4, and Week 8 (primary endpoint at Week 8).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06960330, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.