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

NCT07562685 | Not Yet Recruiting

• 1 other identifier: DGRC/MSPT/26/731
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Knee Osteoarthristis

Keywords

knee Osteoarthirits; Knee Brace; Offloader Brace; Functional Outcome; Gait Variability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Gait Variability

  Time Frame: Baseline and after 4 weeks of intervention

• Functional Outcome

  Time Frame: Baseline and after 4 weeks of intervention

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

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

CONTROL GROUP

ACTIVE COMPARATOR

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

Interventions

Knee and Heel Off-Loader Brace with NWB Strength Training DEVICE

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.

EXPERIMENTAL GROUP

Conventional Knee Off-Loader Brace with NWB Strength Training DEVICE

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 .

CONTROL GROUP

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Officials

• Muhammad Tariq Rafiq, PhD

  Lahore University of Biological & Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jabar Ali, MSPT

CONTACT

03164680178; jabaralijabar5617@gmail.com

MUHAMMAD TARIQ RAFIQ, PhD

CONTACT

rafiqmuhammadtariq149@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: 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): June 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, CSR
• Time Frame: After completion of the study until the time of 5 years.