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

Official title

Effect of Knee and Heel Off-Loader Brace With Non Weight Bearing Strength Training on Pain, Gait Variability, and Functional Outcome in Knee Osteoarthritis: A Randomized Controlled Trial

Overview

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.

Detailed description

KOA is a degenerative joint disorder characterized by progressive cartilage breakdown, joint pain, stiffness, muscle weakness, and impaired functional mobility. One of the key biomechanical issues in KOA is increased medial compartment loading, which contributes to disease progression and functional limitations. Additionally, individuals with KOA commonly exhibit altered gait patterns and increased gait variability, reflecting impaired neuromuscular control and increased risk of falls.

Conservative management strategies for KOA primarily focus on pain reduction, improving joint function, and enhancing quality of life. Among these, biomechanical interventions such as knee off-loader braces aim to redistribute joint loading, while strengthening exercises target neuromuscular deficits. However, traditional weight-bearing exercises may increase joint stress and pain, making NWB strength training a safer and more effective alternative.

Knee and heel off-loader braces have been introduced as an advanced biomechanical intervention designed to reduce joint loading by altering lower limb alignment and redistributing forces away from the affected knee compartment. While these braces effectively address mechanical stress, they do not directly improve muscle strength and neuromuscular control. Conversely, NWB strength training improves muscular support and joint stability but does not correct abnormal loading patterns.

Despite the individual effectiveness of these interventions, limited research has explored their combined effect. Therefore, this study aims to evaluate the synergistic impact of combining knee and heel off-loader brace with NWB strength training on pain, gait variability, and functional outcome in KOA.

This study will adopt a single-blinded, two-arm parallel randomized controlled design. A total of 20 participants will be randomly allocated into two groups. The experimental group will receive a knee and heel off-loader brace along with a structured NWB strength training program, while the control group will receive a conventional knee off-loader brace with the same exercise protocol.

The intervention will be conducted over four weeks, with three sessions per week. Outcome measures will include the Numeric Pain Rating Scale (NPRS) for pain, the JACK scale for gait variability, and the Knee Injury and Osteoarthritis Outcome Score (KOOS) for functional assessment.

The study aims to determine whether combining biomechanical off-loading with neuromuscular strengthening provides superior clinical benefits. It is expected that this integrated approach will lead to greater pain reduction, improved gait stability, and enhanced functional performance, thereby contributing to evidence-based rehabilitation strategies for individuals with knee osteoarthritis.

Interventions

• Device Knee and Heel Off-Loader Brace with NWB Strength Training
  Participants 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.
• Device Conventional Knee Off-Loader Brace with NWB Strength Training
  Participants 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 .

Primary outcome measures

• Pain Intensity [Time frame: Baseline and after 4 weeks of intervention]

Secondary outcome measures (2)

• Gait Variability [Time frame: Time Frame: Baseline and after 4 weeks of intervention]
• Functional Outcome [Time frame: Time Frame: Baseline and after 4 weeks of intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07562685 · DGRC/MSPT/26/731

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗