Effects of Two Bar Knee Off-Load Brace With Non Weight Bearing Strength Training Among Knee Osteoarthritis Patients

Effects of Two Bar Knee Off-Load Brace With Non Weight Bearing Strength Training on Pain, Stiffness, and Satisfaction Among Knee Osteoarthritis Patients: A Randomized Controlled Trial

The current study is a single-blind, parallel-group randomized controlled trial involving 18 participants with knee osteoarthritis. The trial will compare a program of two-bar knee off-load brace combined with non-weight bearing strength training with a program of standard knee off-loader brace combined with non-weight bearing strength training. Interventions will be delivered three times per week for six weeks. The primary outcomes are pain, stiffness, and patient satisfaction. Assessments will be conducted at baseline and after six weeks. The trial will be carried out at Water and Power Development Authority Hospital Complex and Fatima Memorial Hospital, Lahore. The hypothesis is that the two-bar knee off-load brace combined with non-weight bearing strength training will result in greater reductions in pain and stiffness as well as improved patient satisfaction compared with the standard knee off-loader brace with non-weight bearing strength training.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training Intervention; Other: Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention

Detailed Description

Knee osteoarthritis is a progressive musculoskeletal condition characterized by joint degeneration, pain, stiffness, and reduced functional mobility. Conservative management strategies such as therapeutic exercise and knee bracing are commonly recommended to reduce symptoms and improve functional outcomes. Knee off-loader braces are designed to reduce joint loading by redistributing forces across the knee joint during weight-bearing activities. Recently, interest has increased in braces that provide external axial unloading through structural support, potentially reducing compressive forces on the tibio-femoral joint more effectively than traditional braces.

Non-weight bearing strength training is frequently used in rehabilitation programs for knee osteoarthritis because it strengthens periarticular muscles while minimizing joint loading during exercise. Combining mechanical unloading through bracing with structured non-weight bearing strengthening may provide a complementary therapeutic effect by simultaneously reducing mechanical stress on the knee joint and improving muscular support and joint stability.

This study will evaluate the effectiveness of a two-bar knee off-load brace combined with non-weight bearing strength training compared with a standard knee off-loader brace combined with the same strengthening program. The trial will use a single-blind, parallel-group randomized controlled design with a total of 18 participants diagnosed with knee osteoarthritis. Participants will be randomly assigned to one of two intervention groups.

The two bar knee offload brace group will receive a two-bar knee off-loader brace designed with medial and lateral rigid support bars extending from the thigh to the ground, allowing partial axial load transfer while maintaining physiological knee motion. Participants will also perform a structured non-weight bearing strength training program targeting hip, knee, and ankle musculature.

The standard brace group will receive a standard knee off-loader brace that redistributes knee joint forces without external axial load support, along with the same non-weight bearing strength training protocol. Both interventions will be administered three times per week for six weeks, with each treatment session lasting approximately 45-60 minutes.

The study aims to determine whether the addition of enhanced axial unloading through the two-bar knee off-loader brace leads to greater improvements in pain, stiffness, and patient satisfaction compared with the standard brace. Outcome measures will include the Numeric Pain Rating Scale for pain intensity, the stiffness subscale of the Western Ontario and McMaster Universities Osteoarthritis Index, and the satisfaction section of the Knee Society Score. Assessments will be conducted at baseline and after completion of the six-week intervention period.

The current study will be conducted at the physiotherapy departments of Water and Power Development Authority Hospital Complex and Fatima Memorial Hospital, Lahore. Standardized procedures will be followed to ensure consistent delivery of interventions and accurate outcome assessment across all participants.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hareem Zahra, MSPT; Phone Number: +923224485265; Email: MSPT243009@ubas.edu.pk

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age between 45-60 years
• Have a confirmed diagnosis of KOA of grade II to III according to Kellgren and Lawrence classification
• Participants must have had no changes in pharmacological treatment and not received any intra-articular knee injection (glucocorticosteroids with analgesics) during the last three months
• Patient must be able to understand instructions and complete self-reported questionnaires

Exclusion Criteria:

• Participants will be excluded if they have severe venous insufficiency
• Acute inflammatory knee conditions (septic arthritis, gout, pseudogout)
• Systemic disease (rheumatoid arthritis, fibromyalgia)
• Traumatic onset of knee pain
• Individuals with a major lower-limb injury requiring surgery or physiotherapy within the past year

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Two-Bar Knee Off-Load Brace Group; The two-bar knee off-load brace is designed with medial and lateral rigid support bars that partially bear axial load and reduce compressive forces on the knee joint during weight-bearing activities. Participants will also perform a structured non-weight bearing strengthening program targeting the hip, knee, and ankle muscles.	Other: Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training Intervention; Participants will be instructed to wear the two-bar knee off-loader brace during waking hours. Participants will be advised not to wear the brace during sleep, bathing, or personal hygiene activities, and to remove it during prolonged periods of sitting or lying down. Daily skin inspection will be recommended to monitor for discomfort or irritation. The Non-Weight Bearing Strength Training is a structured program of strengthening and stretching exercises for the lower extremities. The strength training will be administered three times per week throughout the six-week intervention period. Each treatment session will begin with 10 minutes warm-up, followed by resistance training, and ending with 10 minutes cool-down. The overall session duration is expected to range between 45 and 60 minutes. Rest intervals of 20-30 seconds will be provided between sets, with a 1-minute rest period before transitioning to the next exercise.
Active Comparator: Standard Knee Off-Loader Brace Group; The standard brace redistributes joint forces within the knee joint but does not provide external axial load support. Participants will perform the same non-weight bearing strengthening exercises as the experimental group.	Other: Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention; Participants in the control group will receive the same non-weight bearing strength training program along with the use of a standard knee off-loader brace. The strengthening program will target hip, knee, and ankle muscles and will be performed in non-weight bearing positions to minimize joint stress while improving muscular strength and joint stability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Pain	Pain intensity will be measured using the Numeric Pain Rating Scale (NPRS). The NPRS is a widely used, validated self-reported scale that assesses the intensity of pain on an 11-point numerical scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Participants will be asked to rate their average knee pain based on their experience. The NPRS is simple to administer and has demonstrated excellent reliability and validity in musculoskeletal conditions. Pain levels will be categorized as mild (1-3), moderate (4-6), and severe (7-10). Changes in NPRS scores from baseline to the end of the intervention will be used to determine the effectiveness of the treatment.	From enrollment to the end of treatment at 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stiffness	Stiffness will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale. The WOMAC is a disease-specific questionnaire developed for individuals with osteoarthritis. The stiffness subscale consists of two items that assess the severity of knee stiffness after first waking in the morning and later in the day. Each item is scored on a Likert scale, producing a total stiffness score ranging from 0 to 8, where higher scores indicate greater stiffness severity. The WOMAC has demonstrated good reliability and validity for assessing symptoms and functional limitations in patients with knee osteoarthritis.	From enrollment to the end of treatment at 6 weeks
Patient Satisfaction	Patient satisfaction will be measured using the Satisfaction Section of the Knee Society Score (KSS). This section consists of five items evaluating the patient's satisfaction with knee function and treatment outcomes. Each item is scored from 0 to 8, giving a total score ranging from 0 to 40, where higher scores indicate greater satisfaction. The Knee Society Score is a validated tool widely used in clinical research for evaluating patient-reported outcomes related to knee conditions.	From enrollment to the end of treatment at 6 weeks

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): August 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 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Knee Pain; Knee Osteoarthritis; Stiffness; Brace; Patient Satisfaction
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Behavior; Treatment Adherence and Compliance; Health Behavior; Osteoarthritis, Knee; Patient Satisfaction
• Other Study ID Numbers: DGRC/MSPT/26/728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Only IPD used in the results publication will be shared.
• IPD Sharing Time Frame: It will be available after the completion of the study.
• IPD Sharing Access Criteria: Through the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; 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