Effect of Knee and Heel Off-Loader Brace With Non Weight Bearing Strength in Knee Osteoarthritis

Starting soon · Not applicable

Conditions studied: Knee Osteoarthristis

In brief

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.

Key facts

Study ID

NCT07562685

Run by

Lahore University of Biological and Applied Sciences

People needed

20

Starts

2026-05-01

Expected to finish

2026-09-01

Last updated by the study team

2026-05-28

Who can join

Age: 35 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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