Knee OsteoarthristisNCT07562685
Effect of Knee and Heel Off-Loader Brace With Non Weight Bearing Strength in Knee Osteoarthritis
A study testing Knee and Heel Off-Loader Brace with NWB Strength Training and Conventional Knee Off-Loader Brace with NWB Strength Training in people with Knee Osteoarthristis, run by Lahore University of Biological and Applied Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Knee and Heel Off-Loader Brace with NWB Strength Training and Conventional Knee Off-Loader Brace with NWB Strength Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
MUHAMMAD TARIQ RAFIQ, PhD contact
About this study
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
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.
Read the 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.
- Conditions
- Knee Osteoarthristis
- Being tested
- Knee and Heel Off-Loader Brace with NWB Strength Training, Conventional Knee Off-Loader Brace with NWB Strength Training
- Keywords
- knee Osteoarthirits, Knee Brace, Offloader Brace, Functional Outcome, Gait Variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee and Heel Off-Loader Brace with NWB Strength TrainingDevice
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.
Conventional Knee Off-Loader Brace with NWB Strength TrainingDevice
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Conventional Knee Off-Loader Brace with NWB Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and after 4 weeks of intervention
Secondary outcomes (2)
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.
Measured: 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
Measured: Time Frame: Baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study startMay 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Muhammad Tariq Rafiq, Lahore University of Biological and Applied Sciences
- Investigators
- Muhammad Tariq Rafiq, PhD, Principal investigator, Lahore University of Biological & Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562685
- Sponsor's protocol ID
- DGRC/MSPT/26/731
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared after completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07562685
- Acronym / sponsor ID
- DGRC/MSPT/26/731
- Conditions
- Knee Osteoarthristis
- Keywords
- knee Osteoarthirits, Knee Brace, Offloader Brace, Functional Outcome, Gait Variability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | Device: Knee and Heel Off-Loader Brace with NWB Strength TrainingParticipants 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. |
| CONTROL GROUP | Active comparator | Device: Conventional Knee Off-Loader Brace with NWB Strength TrainingParticipants in the control group will receive a conventional knee off-loader brace combined with the same NWB strength training program. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee and Heel Off-Loader Brace with NWB Strength TrainingParticipants 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 | EXPERIMENTAL GROUP |
| Conventional Knee Off-Loader Brace with NWB Strength TrainingParticipants 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 . | Device | CONTROL GROUP |
Primary outcome
Pain Intensity
Time frame: Baseline and after 4 weeks of intervention
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- Individual participant dataSharing planned: Yes. IPD will be shared after completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MUHAMMAD TARIQ RAFIQ, PhD contact
Muhammad Tariq Rafiq, PhD principal investigator
Lahore University of Biological & Applied Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Knee and Heel Off-Loader Brace with NWB Strength Training and Conventional Knee Off-Loader Brace with NWB Strength Training in people with Knee Osteoarthristis, run by Lahore University of Biological and Applied Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jabar Ali, MSPT (03164680178, jabaralijabar5617@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Baseline and after 4 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.