Effect of Knee and Heel Off-Loader Brace With Non Weight Bearing Strength in Knee Osteoarthritis (NCT07562685) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Knee and Heel Off-Loader Brace With Non Weight Bearing Strength in Knee Osteoarthritis
20 participantsStarted 2026-05
Plain-language summary
The current study is a single-blinded, parallel-group pilot randomized controlled trial involving 20 participants diagnosed with knee osteoarthritis (KOA). The trial will compare the effects of a knee and heel off-loader brace combined with non-weight bearing (NWB) strength training versus a conventional knee off-loader brace combined with NWB strength training. Interventions will be delivered three times per week for four weeks.
The primary outcome of the study is pain intensity, while secondary outcomes include gait variability and functional outcome. Assessments will be conducted at baseline and after completion of the intervention period. The study will be carried out at the outpatient physiotherapy departments of Kaazi Hospital and Ghurki Trust Hospital, Lahore.
The hypothesis is that the combination of knee and heel off-loader brace with NWB strength training will result in greater reductions in pain, improved gait variability, and enhanced functional outcomes compared to the conventional knee off-loader brace with NWB strength training.
Who can participate
Age range
35 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinically diagnosed KOA with radiographic Kellgren and Lawrence grade II-III, confirmed within the previous six months
* History of knee pain for at least three months, consistent with chronic KOA
* Ability to ambulate independently, with or without assistive devices
* No change in pharmacological management for KOA during the previous three months
* Ability to understand instructions and complete self reported outcome measures
* Willingness to participate and provision of written informed consent
Exclusion Criteria:
* Severe venous insufficiency or history of deep vein thrombosis
* Acute inflammatory knee conditions (e.g., septic arthritis, acute synovitis)
* Rheumatic or systemic inflammatory joint diseases (e.g., rheumatoid arthritis)
* Traumatic onset of knee pain within the previous six months
* History of major lower limb injury or surgery requiring rehabilitation within the past year
* Neurological or neurodegenerative disorders affecting gait or balance, including Parkinson's disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Intensity
Timeframe: Baseline and after 4 weeks of intervention
Trial details
NCT IDNCT07562685
SponsorLahore University of Biological and Applied Sciences