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

NCT07562646 | Not Yet Recruiting DMC

• 1 other identifier: DGRC/MSPT/26/728
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Knee Pain; Stiffness; Patient Satisfaction; Brace

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Stiffness

  From enrollment to the end of treatment at 6 weeks

• Patient Satisfaction

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Two-Bar Knee Off-Load Brace Group

EXPERIMENTAL

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

Standard Knee Off-Loader Brace Group

ACTIVE COMPARATOR

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

Interventions

Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training Intervention OTHER

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.

Two-Bar Knee Off-Load Brace Group

Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention OTHER

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.

Standard Knee Off-Loader Brace Group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

MeSH Terms

Conditions

Osteoarthritis, Knee; Patient Satisfaction

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Muhammad Tariq Rafiq, PhD

  Lahore University of Biological & Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hareem Zahra, MSPT

CONTACT

+923224485265; MSPT243009@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: It will be available after the completion of the study.
• Access Criteria: Through the corresponding author.