Knee OsteoarthritisNCT06741033
Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial KO
A study testing Conventional physiotherapy and Toe-in gait modification in people with Knee Osteoarthritis, run by Superior University at 1 site in Pakistan.
Trial summary
Medial knee osteoarthritis (OA) remains a prevalent and debilitating condition, despite conventional physiotherapy interventions aimed at reducing pain and improving function. This study investigates the additional benefits of toe-in gait modification when combined with conventional physiotherapy in individuals with… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Conventional physiotherapy and Toe-in gait modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Feb 2024to 1 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of MKOA having Grade 1-3 (radiographic evidence of MKOA)
- Knee pain on most days of previous month. (The most symptomatic side will consider the study limb for participants with bilaterally eligible knees)
- Age > 45
- Ability to walk unaided for at least 25 min
- Gender eligibility both male and female
Who cannot join
- Severe MKOA (Grade 4)
- Lateral OA
- Patella femoral OA
- Previous or planned hip or knee surgery
- Hip or ankle arthritis
- Rheumatoid arthritis
- Severe valgus and varus alignment requiring the use of an assistive device and the inability to walk independently
- Neurological dysfunction
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institute of orthopedic and rehabilitation IOR garden town
Lahore, Punjab Province
About this study
Official title: Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial Knee Osteoarthritis
Medial knee osteoarthritis (OA) remains a prevalent and debilitating condition, despite conventional physiotherapy interventions aimed at reducing pain and improving function. This study investigates the additional benefits of toe-in gait modification when combined with conventional physiotherapy in individuals with medial knee OA. Rooted in biomechanical theories suggesting that altering gait patterns can reduce medial knee load, this research employs a randomized controlled trial methodology.
Read the detailed description
Participants are divided into two groups: one receiving conventional physiotherapy alone, and the other receiving a combination of conventional physiotherapy and toe-in gait modification. Outcomes are assessed over a 8-week period, focusing on pain levels and physical function. The significance of this study lies in its potential to enhance current treatment protocols, offering a more effective, non-invasive intervention to alleviate symptoms and improve the quality of life for those suffering from medial knee OA. The findings could inform clinical practices and pave the way for personalized rehabilitation strategies that incorporate gait modifications, ultimately reducing the healthcare burden associated with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Conventional physiotherapy, Toe-in gait modification
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyDiagnostic test
Conventional physiotherapy of medial knee osteoarthritis patients: Isometric exercises, strengthening exercises, stretching exercises and electrotherapy.
Toe-in gait modificationCombination product
A specific alteration in walking pattern where the toes are directed inward during walking. This modification should be clearly defined, including the degree of inward rotation of the foot and how it is taught and monitored in participants. Toe-in gait modification basically includes decrease foot progression angle from baseline through internal foot rotation. Participants are instructed to increase the Toe-in angle of their study limb by 5 degree and walk at least 5-10 minutes (progressed to 15-20 min after 4 week) with this progression angle.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group I | Experimental | Not described Receives: Diagnostic Test: Conventional physiotherapy |
| Interventional group II | Active comparator | Not described Receives: Combination Product: Toe-in gait modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
NUMERIC PAIN RATING SCALE (NPRS)
The NPRS is 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine
Measured: 12 Months
WOMAC scale
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness, and Physical Function) The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start28 Feb 2024
- Primary completion1 Aug 2024
- Study completion1 Mar 2025 (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 Superior 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741033
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/758
- Status last verified
- Dec 2024
- First submitted
- 13 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Toe-in Gait Modification Along With Conventional Physiotherapy in People With Medial Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06741033
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/758
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 18 Dec 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.
Medial knee osteoarthritis (OA) remains a prevalent and debilitating condition, despite conventional physiotherapy interventions aimed at reducing pain and improving function. This study investigates the additional benefits of toe-in gait modification when combined with conventional physiotherapy in individuals with medial knee OA. Rooted in biomechanical theories suggesting that altering gait patterns can reduce medial knee load, this research employs a randomized controlled trial methodology.
Detailed description
Participants are divided into two groups: one receiving conventional physiotherapy alone, and the other receiving a combination of conventional physiotherapy and toe-in gait modification. Outcomes are assessed over a 8-week period, focusing on pain levels and physical function. The significance of this study lies in its potential to enhance current treatment protocols, offering a more effective, non-invasive intervention to alleviate symptoms and improve the quality of life for those suffering from medial knee OA. The findings could inform clinical practices and pave the way for personalized rehabilitation strategies that incorporate gait modifications, ultimately reducing the healthcare burden associated with knee osteoarthritis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group I | Experimental | Diagnostic Test: Conventional physiotherapy |
| Interventional group II | Active comparator | Combination Product: Toe-in gait modification |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of MKOA having Grade 1-3 (radiographic evidence of MKOA)
- Knee pain on most days of previous month. (The most symptomatic side will consider the study limb for participants with bilaterally eligible knees)
- Age > 45
- Ability to walk unaided for at least 25 min
- Gender eligibility both male and female
Key exclusion criteria (8 listed)
- Severe MKOA (Grade 4)
- Lateral OA
- Patella femoral OA
- Previous or planned hip or knee surgery
- Hip or ankle arthritis
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 |
|---|---|---|
| Conventional physiotherapyConventional physiotherapy of medial knee osteoarthritis patients: Isometric exercises, strengthening exercises, stretching exercises and electrotherapy. | Diagnostic test | Interventional group I |
| Toe-in gait modificationA specific alteration in walking pattern where the toes are directed inward during walking. This modification should be clearly defined, including the degree of inward rotation of the foot and how it is taught and monitored in participants. Toe-in gait modification basically includes decrease foot progression angle from baseline through internal foot rotation. Participants are instructed to increase the Toe-in angle of their study limb by 5 degree and walk at least 5-10 minutes (progressed to 15-20 min after 4 week) with this progression angle. | Combination product | Interventional group II |
Primary outcome
NUMERIC PAIN RATING SCALE (NPRS)
Time frame: 12 Months
The NPRS is 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine
WOMAC scale
Time frame: 12 Months
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales (Pain, Stiffness, and Physical Function) The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score.
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 18 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physiotherapy and Toe-in gait modification in people with Knee Osteoarthritis, run by Superior 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 18 Dec 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?
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?
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?
NUMERIC PAIN RATING SCALE (NPRS) (time frame: 12 Months). 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?
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 18 Dec 2024.