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.
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
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
Parallel
Knee and Heel Off-Loader Brace with NWB Strength Training
DeviceParticipants in the experimental group will receive a combined intervention of knee and heel off-loader brace along with a structured NWB strength training program. The exercise program will be conducted three times per week for four weeks, with each session lasting approximately 45-60 minutes. Exercises will include quadriceps isometrics, straight leg raises, short arc quadriceps, hamstring curls, hip abduction, and glute bridging. Progression will be based on patient tolerance.
Conventional Knee Off-Loader Brace with NWB Strength Training
DeviceParticipants in the control group will receive a conventional knee off-loader brace combined with the same NWB strength training program instead of Knee and Heel Off-Loader Brace .
Pain Intensity
Pain intensity refers to the subjective perception of knee pain experienced by individuals with knee osteoarthritis. In this study, pain will be measured using the Numeric Pain Rating Scale (NPRS) an 11-point self reported scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates worst imaginable pain. Participants will be asked to rate their pain at rest, during walking, and during daily functional activities. The NPRS is a reliable and valid tool commonly used in musculoskeletal conditions and demonstrates excellent test retest reliability and strong construct validity. The primary objective is to evaluate the reduction in pain intensity following the intervention. A decrease in NPRS scores after the intervention period will indicate improvement in pain
Gait Variability
Gait variability refers to the natural step-to-step fluctuations in walking patterns and is an important indicator of gait stability, neuromuscular control, and fall risk. Individuals with knee osteoarthritis often demonstrate increased gait variability due to pain, joint instability, and impaired coordination. In this study, gait variability will be assessed using the JACK Scale, an observational gait assessment tool. Participants will walk along a standardized 10-meter walkway at a comfortable speed, and the assessor will evaluate parameters such as step length consistency, stride symmetry, stance-swing control, and postural stability. Scores will be assigned based on observed deviations, with higher scores indicating greater gait instability and variability. The JACK Scale has demonstrated good reliability and validity in clinical settings.
Functional Outcome
Functional outcome refers to the ability of an individual to perform daily activities, maintain mobility, and participate in physical tasks. In this study, functional outcome will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a validated patient-reported outcome measure consisting of five subscales: Pain, Symptoms, Activities of Daily Living (ADL), Sport and Recreation, and Quality of Life. The ADL subscale will be primarily used to assess functional performance in daily activities such as walking, stair climbing, standing, and bending. Scores are transformed to a 0-100 scale, where higher scores indicate better functional ability and lower disability
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