Knee OsteoarthritisNCT05707000
Comparison of Quadriceps Strengthening and Kinesiotaping on Gait in Knee Osteoarthritis
A study testing group A concentric muscle training and Group B fascilitatory kinesiotaping in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to determine the Effects of facilitatory Kinesio-taping and concentric quadriceps strengthening on gait parameters in knee osteoarthritis. Randomized clinical trials will be done at Physio Experts Clinic, Islamabad. The sample size is 38. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- group A concentric muscle training and Group B fascilitatory kinesiotaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults of age 50- 60 years
- Presence of OA of the knee (using American College of Rheumatology criteria) for ≥6 months
- Knee pain due to tibiofemoral knee OA not from Patellofemoral OA
- Bilateral standing anterior-posterior radiograph demonstrating Kellgren and Lawrence OA grade 2 or 3
Who cannot join
- Knee surgery within last 12 months
- Lumber radiculopathy
- Vascular claudication
- Anterior knee pain due to diagnosed Patellofemoral syndrome/ chondromalacia
- Administered corticosteroid or hyaluronic injections within 3 months
- Any other MSK limitations
- Any cardiovascular problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Concentric Quadriceps Strengthening and Facilitatory Kinesiotaping on Gait Parameters in Knee Osteoarthritis
The aim of this research is to determine the Effects of facilitatory Kinesio-taping and concentric quadriceps strengthening on gait parameters in knee osteoarthritis. Randomized clinical trials will be done at Physio Experts Clinic, Islamabad. The sample size is 38. The subjects were divided in two groups, with 19 subjects in Group A and 19 in Group B. Study duration was of 6 months. Sampling technique applied was Non probability Convenience Sampling technique. Both males and females of aged 50-60 years with Knee OA grade 2 or 3 were included. Tools used in the study are Numeric Pain Rating Score (NPRS), dynamometer, WOMAC questionnaire and Mobile app for measuring Temporospatial gait parameters.
Read the detailed description
Osteoarthritis is one of the most common musculoskeletal disorders in adults. It is a degenerative joint disease affecting 15%-40% of people more than 40 years of age. The term osteoarthritis was authored in 1886 by the English doctor, John Kent Spender. Clinical assessment to recognize OA from RA and other comparable conditions turned out to be broadly acknowledged by the main decade of the twentieth century enormous because of the endeavors set forward by Archibald E.
Osteoarthritis is a degenerative joint condition that causes other joint tissues to lose gross cartilage and to experience morphological damage. Pathological changes seen in knee osteoarthritis joints include progressive loss and destruction of articular cartilage, thickening of the subchondral bone, formation of osteophytes, variable degrees of inflammation of the synovium, degeneration of ligaments and menisci of the knee and hypertrophy of the joint capsule. Biomechanical factor that is assumed to contribute to the etiology of OA is laxity of knee joint, which is described as the rotation or displacement of femur from tibia. One research found that Varus-valgus laxity in patients with unaltered knees and unilateral OA is wider than in stable healthy participants, indicating knee joint laxity may be disease predisposing. the progress of the lateral and medial knee OA, as defined by narrowing of joint space and a degradation of physical activity, was found to have been linked with lower limb valgus-Varus alignment.
The main focus in OA management is on promoting self-management, reducing pain, optimize function, and modifying the disease process and its effects. The primary treatment for OA knee conservatively is physiotherapy which includes strength training, modalities, knee bracing, resistance training and Kinesiotaping. Resistance exercise can reduce knee pain severity and leg strength in participants with symptomatic knee OA. Exercise interventions using free weights or machines have generally focused on movements with concentric muscle contractions. Previous interventions were developed based on loads lifted during the concentric phase.
Kinesiotape (KT), is an elastic woven-cotton strip with a heat- sensitive acrylic adhesive structure.
- Conditions
- Knee Osteoarthritis
- Being tested
- group A concentric muscle training, Group B fascilitatory kinesiotaping
- Keywords
- Knee osteoarthritis, Quadriceps, Kinesiotaping
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group A concentric muscle trainingOther
One set of each of the following exercises will completed during each session:
- leg press,
- knee flexion,
- knee extension,
- Quad drills For each set, 12 repetitions will be performed at a resistance load of 60% of the one-repetition maximum (1RM) for that exercise. The exercises will be performed 2 times a week for 6 weeks.
Group B fascilitatory kinesiotapingOther
Kinesiotaping is applied on the anterior thigh (quadriceps) region starting at 1/5 of the distance between anterosuperior iliac spine (ASIS) and tibia tuberosity. The tape is applied with 20% tension of the tape. The tape was tensioned from proximal region of mid quadriceps down to tibia tuberosity and, once it reached the knee, the tape was divided in the middle allowing it to circle the joint
| Study group | Role | What they receive |
|---|---|---|
| group A, Concentric Muscle Training | Experimental | leg press, knee flexion, knee extension, Quad drills with 1 RM Receives: Other: group A concentric muscle training |
| group B, Quadriceps Facilitatory Kinesiotaping | Experimental | kinesiotaping on the quadriceps muscle in the faciliatory mode Receives: Other: Group B fascilitatory kinesiotaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temporo-spatial Gait Parameters:
Measurement of temporospatial gait parameters (gait velocity, cadence, step length, step width and single support time) and their assessment, and calculating normalized values using the mobile app
Measured: 6 week
Secondary outcomes (3)
Numeric Pain Rating Score (NPRS):
Pain due to Knee OA was assessed using a numerical pain rating scale (NPRS), and scoring range 0, no pain, to 10, maximum pain.
Measured: 6 week
Functional Status (WOMAC Questionnaire):
Functional Status is measured using WOMAC questionnaire. The WOMAC is a self-reported, lower extremity specific questionnaire and contains 24 questions: 17 on physical function, 5 on pain, and 2 on stiffness.
Measured: 6 week
Strength
Strength is calculated using hand held dynamometer that offers a reliable and valid method to quantify quadriceps strength in a clinical environment
Measured: 6 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start1 Jan 2023
- Primary completion15 Oct 2023
- Study completion30 Oct 2023
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 Riphah International UniversityThe 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, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707000
- Sponsor's protocol ID
- RiphahIU farhana Nasir
- Status last verified
- Nov 2023
- First submitted
- 22 Jan 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Concentric Quadriceps Strengthening and Facilitatory Kinesiotaping on Gait Parameters in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05707000
- Acronym / sponsor ID
- RiphahIU farhana Nasir
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Quadriceps, Kinesiotaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 31 Jan 2023 (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 aim of this research is to determine the Effects of facilitatory Kinesio-taping and concentric quadriceps strengthening on gait parameters in knee osteoarthritis. Randomized clinical trials will be done at Physio Experts Clinic, Islamabad. The sample size is 38. The subjects were divided in two groups, with 19 subjects in Group A and 19 in Group B. Study duration was of 6 months. Sampling technique applied was Non probability Convenience Sampling technique. Both males and females of aged 50-60 years with Knee OA grade 2 or 3 were included. Tools used in the study are Numeric Pain Rating Score (NPRS), dynamometer, WOMAC questionnaire and Mobile app for measuring Temporospatial gait parameters.
Detailed description
Osteoarthritis is one of the most common musculoskeletal disorders in adults. It is a degenerative joint disease affecting 15%-40% of people more than 40 years of age. The term osteoarthritis was authored in 1886 by the English doctor, John Kent Spender. Clinical assessment to recognize OA from RA and other comparable conditions turned out to be broadly acknowledged by the main decade of the twentieth century enormous because of the endeavors set forward by Archibald E.
Osteoarthritis is a degenerative joint condition that causes other joint tissues to lose gross cartilage and to experience morphological damage. Pathological changes seen in knee osteoarthritis joints include progressive loss and destruction of articular cartilage, thickening of the subchondral bone, formation of osteophytes, variable degrees of inflammation of the synovium, degeneration of ligaments and menisci of the knee and hypertrophy of the joint capsule. Biomechanical factor that is assumed to contribute to the etiology of OA is laxity of knee joint, which is described as the rotation or displacement of femur from tibia. One research found that Varus-valgus laxity in patients with unaltered knees and unilateral OA is wider than in stable healthy participants, indicating knee joint laxity may be disease predisposing. the progress of the lateral and medial knee OA, as defined by narrowing of joint space and a degradation of physical activity, was found to have been linked with lower limb valgus-Varus alignment.
The main focus in OA management is on promoting self-management, reducing pain, optimize function, and modifying the disease process and its effects. The primary treatment for OA knee conservatively is physiotherapy which includes strength training, modalities, knee bracing, resistance training and Kinesiotaping. Resistance exercise can reduce knee pain severity and leg strength in participants with symptomatic knee OA. Exercise interventions using free weights or machines have generally focused on movements with concentric muscle contractions. Previous interventions were developed based on loads lifted during the concentric phase.
Kinesiotape (KT), is an elastic woven-cotton strip with a heat- sensitive acrylic adhesive structure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A, Concentric Muscle Training | Experimental | Other: group A concentric muscle trainingleg press, knee flexion, knee extension, Quad drills with 1 RM |
| group B, Quadriceps Facilitatory Kinesiotaping | Experimental | Other: Group B fascilitatory kinesiotapingkinesiotaping on the quadriceps muscle in the faciliatory mode |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults of age 50- 60 years
- Presence of OA of the knee (using American College of Rheumatology criteria) for ≥6 months
- Knee pain due to tibiofemoral knee OA not from Patellofemoral OA
- Bilateral standing anterior-posterior radiograph demonstrating Kellgren and Lawrence OA grade 2 or 3
Key exclusion criteria (7 listed)
- Knee surgery within last 12 months
- Lumber radiculopathy
- Vascular claudication
- Anterior knee pain due to diagnosed Patellofemoral syndrome/ chondromalacia
- Administered corticosteroid or hyaluronic injections within 3 months
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 |
|---|---|---|
| group A concentric muscle trainingOne set of each of the following exercises will completed during each session: * leg press, * knee flexion, * knee extension, * Quad drills For each set, 12 repetitions will be performed at a resistance load of 60% of the one-repetition maximum (1RM) for that exercise. The exercises will be performed 2 times a week for 6 weeks. | Other | group A, Concentric Muscle Training |
| Group B fascilitatory kinesiotapingKinesiotaping is applied on the anterior thigh (quadriceps) region starting at 1/5 of the distance between anterosuperior iliac spine (ASIS) and tibia tuberosity. The tape is applied with 20% tension of the tape. The tape was tensioned from proximal region of mid quadriceps down to tibia tuberosity and, once it reached the knee, the tape was divided in the middle allowing it to circle the joint | Other | group B, Quadriceps Facilitatory Kinesiotaping |
Primary outcome
Temporo-spatial Gait Parameters:
Time frame: 6 week
Measurement of temporospatial gait parameters (gait velocity, cadence, step length, step width and single support time) and their assessment, and calculating normalized values using the mobile app
3 secondary outcomes
Numeric Pain Rating Score (NPRS):
Time frame: 6 week
Functional Status (WOMAC Questionnaire):
Time frame: 6 week
Strength
Time frame: 6 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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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. This study is not recruiting at the moment.
Aisha Razzaq, MSPT-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group A concentric muscle training and Group B fascilitatory kinesiotaping in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
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 7 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: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temporo-spatial Gait Parameters: (time frame: 6 week). 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 Nov 2023.