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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthristis
• Intervention / Treatment: Device: Knee and Heel Off-Loader Brace with NWB Strength Training; Device: 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MUHAMMAD TARIQ RAFIQ, PhD; Email: rafiqmuhammadtariq149@gmail.com
• Study Contact Backup: Name: Jabar Ali, MSPT; Phone Number: 03164680178; Email: jabaralijabar5617@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPERIMENTAL GROUP; Participants in the experimental group will receive a structured intervention consisting of two integrated components: knee and heel off-loader brace for approximately 6-8 hours per day as tolerated and NWB strength training exercises three times per week for four weeks each session lasting approximately 45-60 minutes.	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.
Active Comparator: CONTROL GROUP; Participants in the control group will receive a conventional knee off-loader brace combined with the same NWB strength training program.	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and after 4 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Time Frame: Baseline and after 4 weeks of intervention
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	Time Frame: Baseline and after 4 weeks of intervention

Collaborators and Investigators

• Sponsor: Lahore University of Biological and Applied Sciences
• Investigators: Principal Investigator: Muhammad Tariq Rafiq, PhD, Lahore University of Biological & Applied Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 24, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Functional Outcome; Gait Variability; Knee Brace; knee Osteoarthirits; Offloader Brace
• Other Study ID Numbers: DGRC/MSPT/26/731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared after completion of the study
• IPD Sharing Time Frame: After completion of the study until the time of 5 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No