Knee OsteoarthritisNCT07562646
Effects of Two Bar Knee Off-Load Brace With Non Weight Bearing Strength Training Among Knee Osteoarthritis Patients
A study testing Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training Intervention and Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention in people with Knee Osteoarthritis, run by Lahore University of Biological and Applied Sciences.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training Intervention and Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 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 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training Intervention, Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention
- Keywords
- Knee Osteoarthritis, Knee Pain, Stiffness, Patient Satisfaction, Brace
- Medical subject headings
- Osteoarthritis, Knee, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training InterventionOther
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.
Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: From enrollment to the end of treatment at 6 weeks
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 completionAug 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 OsteoarthritisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 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
- NCT07562646
- Sponsor's protocol ID
- DGRC/MSPT/26/728
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07562646
- Acronym / sponsor ID
- DGRC/MSPT/26/728
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Knee Pain, Stiffness, Patient Satisfaction, Brace
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- Aug 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-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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two-Bar Knee Off-Load Brace Group | Experimental | Other: Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training InterventionThe 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. |
| Standard Knee Off-Loader Brace Group | Active comparator | Other: Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training InterventionThe 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training InterventionParticipants 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. | Other | Two-Bar Knee Off-Load Brace Group |
| Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training InterventionParticipants 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. | Other | Standard Knee Off-Loader Brace Group |
Primary outcome
Knee Pain
Time frame: From enrollment to the end of treatment at 6 weeks
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.
2 secondary outcomes
Stiffness
Time frame: From enrollment to the end of treatment at 6 weeks
Patient Satisfaction
Time frame: From enrollment to the end of treatment at 6 weeks
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 1 May 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication will be shared.
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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 principal investigator
Lahore University of Biological & Applied Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Two-Bar Knee Off-Load Brace with Non-Weight Bearing Strength Training Intervention and Standard Knee Off-Loader Brace with Non-Weight Bearing Strength Training Intervention in people with Knee Osteoarthritis, 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 4 inclusion and 5 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 1 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 Hareem Zahra, MSPT (+923224485265, MSPT243009@ubas.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Pain (time frame: From enrollment to the end of treatment at 6 weeks). 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 1 May 2026.