Knee OsteoarthritisNCT06343909
Foot and Hip Abductor Strengthening in Patients With Knee Osteoarthritis.
A study testing Hip abductor strengthening exercise and Intrinsic foot muscle strengthening along with conventional exercises in people with Knee Osteoarthritis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study will be Randomized controlled trail, Subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups. Pre assessment will be done using pain, ROM, function, foot arches and knee alignment as subjective measurement through KOOS questionnaire… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hip abductor strengthening exercise and Intrinsic foot muscle strengthening along with conventional exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Nov 2023to 1 Jun 2024
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain at medial side of the knee.
- patient can walk without walking aids.
Who cannot join
- patient with previous hip, knee and ankle surgery.
- patient who received intraarticular injection.
- patient with neurologic and muscle problem.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intrinsic Foot Muscle Strengthening and Hip Abductor Strengthening on Pain, Range of Motion, Function, Foot Arches and Knee Alignment in Patients With Knee Osteoarthritis
The study will be Randomized controlled trail, Subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups.
Pre assessment will be done using pain, ROM, function, foot arches and knee alignment as subjective measurement through KOOS questionnaire, goniometer, 2D frontal plane projection, Berkemann foot prints using ink and paper ,30s chair stand test, nine step stair climb,40m fast paced walk test,Global rating of change score respectively . One group will be treated with hip abductor strengthening exercise along with conventional exercises and second group will be treated with intrinsic foot muscle strengthening exercise along with conventional exercises. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore
Read the detailed description
Knee osteoarthritis (OA) is a leading cause of joint pain1 and disability2 in middle- and older-aged individuals, and is one of the most commonly managed conditions in primary care3. Recent incidence rates suggest around 6% of people aged over 45 years develop knee symptoms. Knee OA symptoms and radiographic change that worsen over time can lead to costly surgical intervention.
Compressive forces on the knee caused by knee adduction moment on the medial compartment of the joint are associated with the severity of the disease and intensity of pain. In addition, decreased strength of the quadriceps is one of the contributing factors for the onset of the disease.
short foot exercises (SFE) have shown to be effective using the IFM and excluding the EFM found that SFE contracted the intrinsic muscles of the foot to increase the inner arch of the foot, thereby shortening the longitudinal arch.Pronated foot is deeply related to the medial longitudinal arch (MLA) where the presence of a pronated foot consequently leads to a decrease in the MLA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hip abductor strengthening exercise, Intrinsic foot muscle strengthening along with conventional exercises
- Keywords
- Knee Osteoarthritis, KOOS, Strengthening Exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip abductor strengthening exerciseOther
Also called conventional exercises
in this group 15 participants will perform hip abductor streghtning along with conventional exercises .protocol for 8 weeks 24 sessions (3 sessions in a weak) and 10 sec rest between each segment,3 sets and 10 reputations will be performed.
Intrinsic foot muscle strengthening along with conventional exercisesOther
in this group 15 participants will perform Intrinsic foot muscle strengthening along with conventional exercises .protocol for 8 weeks 24 sessions (3 sessions in a weak) and 10 sec rest between each segment,3 sets and 10 repitations will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Hip abductor strengthening exercise along with conventional exercises | Active comparator | Hip abductor strengthening Participant was positioned in side lying with bottom leg hip abducting to a 45-degree and knee in flexion. The uppermost leg was actively abducted while it remains in slight extension making sure no rotation occurred. Participant was instructed to hold the leg in that position for 5-10 seconds and then to lower it to resting position.
Participant was instructed to repeat the exercise with weight cuff attached to the proximal part of ankle Receives: Other: Hip abductor strengthening exercise |
| intrinsic foot muscle strengthening exercise along with conventional exercises | Active comparator | Wring towel with feet:
. Patient in sitting position, place a hand towel flat on the floor pull the towel towards your heel.
Grapping object with toes:
Sitting, place the object flat on the floor.
. Hold it for a second and then according to the resistance of the release it.
Toe abduction (hallux and 2nd toe):
Sitting place a small band between the hallux and second toe. Open and separate your toe and then squeeze the toe against the resistance of elastic. Always leave your feet resting on the floor..
Toggle toe support:
Sitting with feet resting on the floor, alternately touch the first and fifth toes on the floor. Be careful not to move your knees. Receives: Other: Intrinsic foot muscle strengthening along with conventional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Osteoarthritis Outcome Score (KOOS)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury.A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems).
Measured: 8 weeks
Berkemann foot prints
For arch measurement, the longitudinal and horizontal arch lengths were recorded for the left and right feet to create a static standing position using a Berkemann footprint
Measured: 8 weeks
Secondary outcomes (6)
Frontal plane projection
Two-dimensional (2D) frontal-plane projection angles of hip and knee alignment were measured during a single-leg step-down performed from a 15-cm step
Measured: 8 weeks
Goniometer
Universal Goniometer (UG) An instrument called a goniometer is used to measure a joint's range of motion.
Measured: 8 weeks
30 seconds chair stand test
This test used to measure physical function.
Measured: 8 weeks
Overall self-perception by Global Rating of Change Score
Overall self-perception will be evaluated by the Global Rating of Change Score, an 11-point scale designed to quantify a patient's improvement or deterioration over time. Higher scores indicate better recovery from KOA
Measured: 8 weeks
9 step stairs climb test.
This test used to measure physical function.
Measured: 8 weeks
40-m fast-paced walk test
This test used to measure physical function.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start23 Nov 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Sanaullah, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343909
- Sponsor's protocol ID
- REC/RCR & AHS/23/0197Ayesha
- Status last verified
- Sep 2024
- First submitted
- 25 Mar 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Lyles M, Guermazi A, Bennell KL, Loeser RF. Effect of High-Intensity Strength Training on Knee Pain and Knee Joint Compressive Forces Among Adults With Knee Osteoarthritis: The START Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):646-657. doi: 10.1001/jama.2021.0411.
PubMed 33591346Dantas G, Sacco ICN, Dos Santos AF, Watari R, Matias AB, Serrao PRMS, Pott-Junior H, Salvini TF. Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e039279. doi: 10.1136/bmjopen-2020-039279.
PubMed 32978204Samuel AJ, Kanimozhi D. Outcome measures used in patient with knee osteoarthritis: With special importance on functional outcome measures. Int J Health Sci (Qassim). 2019 Jan-Feb;13(1):52-60.
PubMed 30842718Hashimoto T, Sakuraba K. Strength training for the intrinsic flexor muscles of the foot: effects on muscle strength, the foot arch, and dynamic parameters before and after the training. J Phys Ther Sci. 2014 Mar;26(3):373-6. doi: 10.1589/jpts.26.373. Epub 2014 Mar 25.
PubMed 24707086Kim I, Kim HA, Seo YI, Song YW, Hunter DJ, Jeong JY, Kim DH. Tibiofemoral osteoarthritis affects quality of life and function in elderly Koreans, with women more adversely affected than men. BMC Musculoskelet Disord. 2010 Jun 22;11:129. doi: 10.1186/1471-2474-11-129.
PubMed 20569450
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrinsic Foot Muscle Strengthening and Hip Abductor Strengthening on Pain, Range of Motion, Function, Foot Arches and Knee Alignment in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06343909
- Acronym / sponsor ID
- REC/RCR & AHS/23/0197Ayesha
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, KOOS, Strengthening Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 3 Apr 2024 (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 study will be Randomized controlled trail, Subject diagnosed with knee osteoarthritis meeting predetermined inclusion and exclusion criteria will be divided into two groups.
Pre assessment will be done using pain, ROM, function, foot arches and knee alignment as subjective measurement through KOOS questionnaire, goniometer, 2D frontal plane projection, Berkemann foot prints using ink and paper ,30s chair stand test, nine step stair climb,40m fast paced walk test,Global rating of change score respectively . One group will be treated with hip abductor strengthening exercise along with conventional exercises and second group will be treated with intrinsic foot muscle strengthening exercise along with conventional exercises. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore
Detailed description
Knee osteoarthritis (OA) is a leading cause of joint pain1 and disability2 in middle- and older-aged individuals, and is one of the most commonly managed conditions in primary care3. Recent incidence rates suggest around 6% of people aged over 45 years develop knee symptoms. Knee OA symptoms and radiographic change that worsen over time can lead to costly surgical intervention.
Compressive forces on the knee caused by knee adduction moment on the medial compartment of the joint are associated with the severity of the disease and intensity of pain. In addition, decreased strength of the quadriceps is one of the contributing factors for the onset of the disease.
short foot exercises (SFE) have shown to be effective using the IFM and excluding the EFM found that SFE contracted the intrinsic muscles of the foot to increase the inner arch of the foot, thereby shortening the longitudinal arch.Pronated foot is deeply related to the medial longitudinal arch (MLA) where the presence of a pronated foot consequently leads to a decrease in the MLA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hip abductor strengthening exercise along with conventional exercises | Active comparator | Other: Hip abductor strengthening exerciseHip abductor strengthening Participant was positioned in side lying with bottom leg hip abducting to a 45-degree and knee in flexion. The uppermost leg was actively abducted while it remains in slight extension making sure no rotation occurred. Participant was instructed to hold the leg in that position for 5-10 seconds and then to lower it to resting position. Participant was instructed to repeat the exercise with weight cuff attached to the proximal part of ankle |
| intrinsic foot muscle strengthening exercise along with conventional exercises | Active comparator | Other: Intrinsic foot muscle strengthening along with conventional exercisesWring towel with feet: . Patient in sitting position, place a hand towel flat on the floor pull the towel towards your heel. Grapping object with toes: Sitting, place the object flat on the floor. . Hold it for a second and then according to the resistance of the release it. Toe abduction (hallux and 2nd toe): Sitting place a small band between the hallux and second toe. Open and separate your toe and then squeeze the toe against the resistance of elastic. Always leave your feet resting on the floor.. Toggle toe support: Sitting with feet resting on the floor, alternately touch the first and fifth toes on the floor. Be careful not to move your knees. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pain at medial side of the knee.
- patient can walk without walking aids.
Key exclusion criteria (3 listed)
- patient with previous hip, knee and ankle surgery.
- patient who received intraarticular injection.
- patient with neurologic and muscle problem.
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 |
|---|---|---|
| Hip abductor strengthening exerciseAlso: conventional exercisesin this group 15 participants will perform hip abductor streghtning along with conventional exercises .protocol for 8 weeks 24 sessions (3 sessions in a weak) and 10 sec rest between each segment,3 sets and 10 reputations will be performed. | Other | Hip abductor strengthening exercise along with conventional exercises |
| Intrinsic foot muscle strengthening along with conventional exercisesin this group 15 participants will perform Intrinsic foot muscle strengthening along with conventional exercises .protocol for 8 weeks 24 sessions (3 sessions in a weak) and 10 sec rest between each segment,3 sets and 10 repitations will be performed. | Other | intrinsic foot muscle strengthening exercise along with conventional exercises |
Primary outcome
Knee Osteoarthritis Outcome Score (KOOS)
Time frame: 8 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury.A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems).
Berkemann foot prints
Time frame: 8 weeks
For arch measurement, the longitudinal and horizontal arch lengths were recorded for the left and right feet to create a static standing position using a Berkemann footprint
6 secondary outcomes
Frontal plane projection
Time frame: 8 weeks
Goniometer
Time frame: 8 weeks
30 seconds chair stand test
Time frame: 8 weeks
Overall self-perception by Global Rating of Change Score
Time frame: 8 weeks
9 step stairs climb test.
Time frame: 8 weeks
40-m fast-paced walk test
Time frame: 8 weeks
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 4 Sep 2024.
- Background: PubMed 33591346Messier SP, Mihalko SL, Beavers DP, Nicklas BJ, DeVita P, Carr JJ, Hunter DJ, Lyles M, Guermazi A, Bennell KL, Loeser RF. Effect of High-Intensity Strength Training on Knee Pain and Knee Joint Compressive Forces Among Adults With Knee Osteoarthritis: The START Randomized Clinical Trial. JAMA. 2021 Feb 16;325(7):646-657. doi: 10.1001/jama.2021.0411.
- Background: PubMed 32978204Dantas G, Sacco ICN, Dos Santos AF, Watari R, Matias AB, Serrao PRMS, Pott-Junior H, Salvini TF. Effects of a foot-ankle strengthening programme on clinical aspects and gait biomechanics in people with knee osteoarthritis: protocol for a randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e039279. doi: 10.1136/bmjopen-2020-039279.
- Background: PubMed 30842718Samuel AJ, Kanimozhi D. Outcome measures used in patient with knee osteoarthritis: With special importance on functional outcome measures. Int J Health Sci (Qassim). 2019 Jan-Feb;13(1):52-60.
- Background: PubMed 24707086Hashimoto T, Sakuraba K. Strength training for the intrinsic flexor muscles of the foot: effects on muscle strength, the foot arch, and dynamic parameters before and after the training. J Phys Ther Sci. 2014 Mar;26(3):373-6. doi: 10.1589/jpts.26.373. Epub 2014 Mar 25.
- Background: PubMed 20569450Kim I, Kim HA, Seo YI, Song YW, Hunter DJ, Jeong JY, Kim DH. Tibiofemoral osteoarthritis affects quality of life and function in elderly Koreans, with women more adversely affected than men. BMC Musculoskelet Disord. 2010 Jun 22;11:129. doi: 10.1186/1471-2474-11-129.
- Individual participant dataSharing planned: No
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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.
Muhammad Sanaullah, MS 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 Hip abductor strengthening exercise and Intrinsic foot muscle strengthening along with conventional exercises 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 2 inclusion and 3 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 4 Sep 2024. 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?
Knee Osteoarthritis Outcome Score (KOOS) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06343909, which also lists 5 linked publications.
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 4 Sep 2024.