Knee OsteoarthritisTIKOANCT07097649
Effects of Textured Insoles on Balance, Physical Performance, and Plantar Pressure in Older Adults With Knee Osteoarthritis
A study testing Textured lateral wedge insole and Use of lateral wedge flat insole in people with Knee Osteoarthritis, run by Esra Nur Turkmen.
Trial summary
This study aims to investigate the effects of textured insoles on balance, physical performance, and plantar pressure distribution in older adults with medial compartment knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 65 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Textured lateral wedge insole and Use of lateral wedge flat insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Oct 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 65 to 75 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged between 65 and 75 years
- Diagnosed with medial compartment knee osteoarthritis
- Able to walk independently without assistive devices
- Having foot size compatible with available insole sizes
- Volunteering to participate in the study and providing informed consent
Who cannot join
- Diagnosed with neurological diseases (e.g., stroke, Parkinson's disease, multiple sclerosis)
- Diagnosed with vestibular disorders or balance problems due to inner ear issues
- Having a history of lower extremity surgery in the past year
- Severe foot deformity that prevents insole use
- Having visual impairment that is not corrected with glasses
- Currently using a walking aid (cane, walker, etc.)
- Cognitive impairment or inability to follow instructions
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: Investigation of the Effects of Lateral Wedge Textured Insoles on Balance, Physical Performance, and Plantar Pressure Distribution in Older Adults With Medial Knee Osteoarthritis
This study aims to investigate the effects of textured insoles on balance, physical performance, and plantar pressure distribution in older adults with medial compartment knee osteoarthritis. Participants will be randomly assigned to two groups: the intervention group will receive textured insoles, while the control group will receive flat insoles without texture. Both groups will use their respective insoles for 4 weeks in their daily life. The study includes pre- and post-intervention assessments using balance platforms, functional performance tests (such as the Timed Up and Go, 30-second Chair Stand Test, and Step Test), and plantar pressure analysis. This randomized controlled study is designed to evaluate the effectiveness of textured insoles as a non-invasive and easily applicable rehabilitation method in improving balance and pressure distribution in elderly individuals with knee osteoarthritis.
Read the detailed description
This randomized controlled trial will include older adults aged 65 and over who have been diagnosed with medial compartment knee osteoarthritis according to the American College of Rheumatology criteria and have radiological evidence (Kellgren-Lawrence grade 2 or 3).
Eligible participants will be randomly assigned into two groups: a textured insole group and a flat insole group. Participants will wear the insoles in their daily footwear for a period of 4 weeks.
Baseline and follow-up assessments will include:
- Static and dynamic plantar pressure distribution using the Diasu® baropodometric system.
- Balance assessment using the HUR Smart Balance platform under four conditions (eyes open, eyes closed, eyes open on unstable surface, eyes closed on unstable surface).
- Functional performance tests: Timed Up and Go (TUG), 30-second Chair Stand Test, and Step Test.
- Disease-specific questionnaires: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).
- Q-angle and knee proprioception measurement. Data will be analyzed to determine whether the use of textured insoles improves balance, physical performance, and plantar pressure distribution more effectively than flat insoles in older individuals with knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Textured lateral wedge insole, Use of lateral wedge flat insole
- Keywords
- Medial Compartment Knee Osteoarthritis, Textured Insoles, Balance, Plantar Pressure, Physical Performance
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Textured lateral wedge insoleDevice
Also called Lateral wedge textured insole
Participants in the experimental group will wear custom-designed textured lateral wedge insoles made from EVA material. These insoles incorporate lateral wedging to offload the medial knee compartment and a textured surface to enhance plantar sensory input. Participants will use the insoles during daily activities for a period of 8 weeks, with no additional intervention or exercise protocol.
Use of lateral wedge flat insoleDevice
Participants in this arm will use a customized lateral wedge flat insole with the same lateral inclination as the experimental insole but without any textured surface. This design allows for controlling the mechanical effect of the wedge while eliminating additional sensory stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Textured insoles group | Experimental | Participants will use textured insoles for 8 weeks. Receives: Device: Textured lateral wedge insole |
| Lateral wedge flat insoles group | Active comparator | The researchers will use flat insoles with lateral wedges for 8 weeks. Receives: Device: Use of lateral wedge flat insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 30-Second Chair Stand Test Performance
Physical performance will be assessed using the 30-Second Chair Stand Test. The number of completed chair stands within 30 seconds will be recorded before and after the insole usage period.
Measured: 8 weeks
Change in Timed Up and Go (TUG) Test Performance
Physical performance will be assessed using the Timed Up and Go (TUG) test. The time (in seconds) required to complete the task will be recorded before and after the insole usage period.
Measured: 8 weeks
Change in Step Test Performance
Physical performance will be assessed using the Step Test. The number of completed steps within the allotted time will be recorded before and after the insole usage period.
Measured: 8 weeks
Change in Static Balance Score
Static balance performance will be assessed using the HUR Smart Balance System under four conditions (eyes open, eyes closed, eyes open on unstable surface, and eyes closed on unstable surface). The static balance score will be recorded before and after the intervention.
Measured: 8 weeks
Change in Proprioception Disturbance Score
Proprioceptive balance control will be evaluated using the proprioception disturbance score generated by the HUR Smart Balance System. Measurements will be recorded before and after the intervention.
Measured: 8 weeks
Change in Visual Dependency Score
Visual dependency during postural tasks will be assessed using the HUR Smart Balance System under eyes open and eyes closed conditions. The visual dependency score will be recorded before and after the intervention.
Measured: 8 weeks
Change in Left-Right Weight Distribution
Weight distribution between the left and right sides of the body will be measured using the HUR Smart Balance System during static standing. The distribution will be recorded as a percentage before and after the intervention.
Measured: 8 weeks
Change in Peak Plantar Pressure
Peak plantar pressure (measured in kilopascals) will be assessed using the DIASU® digital baropodometric scanning system and Milletrix software. Measurements will be conducted under both barefoot and insole conditions, before and after the intervention.
Measured: 8 weeks
Change in Plantar Contact Area
Plantar contact area (measured in square centimeters) will be assessed using the DIASU® digital baropodometric scanning system and Milletrix software. Analyses will be performed under both barefoot and insole conditions, before and after the intervention.
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 posted31 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 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.
- 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
- Model description
- Participants will be randomized into two parallel arms: the intervention group will receive textured lateral wedge insoles, and the control group will receive flat lateral wedge insoles without texture. Both groups will wear the insoles in their daily footwear for 4 weeks. All participants will be assessed using standardized protocols covering balance, plantar pressure distribution, physical performance, and biomechanical parameters, through objective measurement systems.
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esra Nur Turkmen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esra Nur Turkmen, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097649
- Sponsor's protocol ID
- LHU-TEXTINSOLE-2025-01
- Acronym
- TIKOA
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to share individual participant data (IPD) due to the study's limited scope and ethical considerations. Data sharing might be considered in the future upon justified request and with appropriate ethical approval.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Lateral Wedge Textured Insoles on Balance, Physical Performance, and Plantar Pressure Distribution in Older Adults With Medial Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07097649
- Acronym / sponsor ID
- TIKOA / LHU-TEXTINSOLE-2025-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Medial Compartment Knee Osteoarthritis, Textured Insoles, Balance, Plantar Pressure, Physical Performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Esra Nur TurkmenUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 31 Jul 2025 (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.
This study aims to investigate the effects of textured insoles on balance, physical performance, and plantar pressure distribution in older adults with medial compartment knee osteoarthritis. Participants will be randomly assigned to two groups: the intervention group will receive textured insoles, while the control group will receive flat insoles without texture. Both groups will use their respective insoles for 4 weeks in their daily life. The study includes pre- and post-intervention assessments using balance platforms, functional performance tests (such as the Timed Up and Go, 30-second Chair Stand Test, and Step Test), and plantar pressure analysis. This randomized controlled study is designed to evaluate the effectiveness of textured insoles as a non-invasive and easily applicable rehabilitation method in improving balance and pressure distribution in elderly individuals with knee osteoarthritis.
Detailed description
This randomized controlled trial will include older adults aged 65 and over who have been diagnosed with medial compartment knee osteoarthritis according to the American College of Rheumatology criteria and have radiological evidence (Kellgren-Lawrence grade 2 or 3).
Eligible participants will be randomly assigned into two groups: a textured insole group and a flat insole group. Participants will wear the insoles in their daily footwear for a period of 4 weeks.
Baseline and follow-up assessments will include:
- Static and dynamic plantar pressure distribution using the Diasu® baropodometric system.
- Balance assessment using the HUR Smart Balance platform under four conditions (eyes open, eyes closed, eyes open on unstable surface, eyes closed on unstable surface).
- Functional performance tests: Timed Up and Go (TUG), 30-second Chair Stand Test, and Step Test.
- Disease-specific questionnaires: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and the Knee Injury and Osteoarthritis Outcome Score (KOOS).
- Q-angle and knee proprioception measurement. Data will be analyzed to determine whether the use of textured insoles improves balance, physical performance, and plantar pressure distribution more effectively than flat insoles in older individuals with knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel arms: the intervention group will receive textured lateral wedge insoles, and the control group will receive flat lateral wedge insoles without texture. Both groups will wear the insoles in their daily footwear for 4 weeks. All participants will be assessed using standardized protocols covering balance, plantar pressure distribution, physical performance, and biomechanical parameters, through objective measurement systems.
| Arm | Type | Receives |
|---|---|---|
| Textured insoles group | Experimental | Device: Textured lateral wedge insoleParticipants will use textured insoles for 8 weeks. |
| Lateral wedge flat insoles group | Active comparator | Device: Use of lateral wedge flat insoleThe researchers will use flat insoles with lateral wedges for 8 weeks. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Aged between 65 and 75 years
- Diagnosed with medial compartment knee osteoarthritis
- Able to walk independently without assistive devices
- Having foot size compatible with available insole sizes
- Volunteering to participate in the study and providing informed consent
Key exclusion criteria (7 listed)
- Diagnosed with neurological diseases (e.g., stroke, Parkinson's disease, multiple sclerosis)
- Diagnosed with vestibular disorders or balance problems due to inner ear issues
- Having a history of lower extremity surgery in the past year
- Severe foot deformity that prevents insole use
- Having visual impairment that is not corrected with glasses
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 |
|---|---|---|
| Textured lateral wedge insoleAlso: Lateral wedge textured insoleParticipants in the experimental group will wear custom-designed textured lateral wedge insoles made from EVA material. These insoles incorporate lateral wedging to offload the medial knee compartment and a textured surface to enhance plantar sensory input. Participants will use the insoles during daily activities for a period of 8 weeks, with no additional intervention or exercise protocol. | Device | Textured insoles group |
| Use of lateral wedge flat insoleParticipants in this arm will use a customized lateral wedge flat insole with the same lateral inclination as the experimental insole but without any textured surface. This design allows for controlling the mechanical effect of the wedge while eliminating additional sensory stimulation. | Device | Lateral wedge flat insoles group |
Primary outcome
Change in 30-Second Chair Stand Test Performance
Time frame: 8 weeks
Physical performance will be assessed using the 30-Second Chair Stand Test. The number of completed chair stands within 30 seconds will be recorded before and after the insole usage period.
Change in Timed Up and Go (TUG) Test Performance
Time frame: 8 weeks
Physical performance will be assessed using the Timed Up and Go (TUG) test. The time (in seconds) required to complete the task will be recorded before and after the insole usage period.
Change in Step Test Performance
Time frame: 8 weeks
Physical performance will be assessed using the Step Test. The number of completed steps within the allotted time will be recorded before and after the insole usage period.
Change in Static Balance Score
Time frame: 8 weeks
Static balance performance will be assessed using the HUR Smart Balance System under four conditions (eyes open, eyes closed, eyes open on unstable surface, and eyes closed on unstable surface). The static balance score will be recorded before and after the intervention.
Change in Proprioception Disturbance Score
Time frame: 8 weeks
Proprioceptive balance control will be evaluated using the proprioception disturbance score generated by the HUR Smart Balance System. Measurements will be recorded before and after the intervention.
Change in Visual Dependency Score
Time frame: 8 weeks
Visual dependency during postural tasks will be assessed using the HUR Smart Balance System under eyes open and eyes closed conditions. The visual dependency score will be recorded before and after the intervention.
Change in Left-Right Weight Distribution
Time frame: 8 weeks
Weight distribution between the left and right sides of the body will be measured using the HUR Smart Balance System during static standing. The distribution will be recorded as a percentage before and after the intervention.
Change in Peak Plantar Pressure
Time frame: 8 weeks
Peak plantar pressure (measured in kilopascals) will be assessed using the DIASU® digital baropodometric scanning system and Milletrix software. Measurements will be conducted under both barefoot and insole conditions, before and after the intervention.
Change in Plantar Contact Area
Time frame: 8 weeks
Plantar contact area (measured in square centimeters) will be assessed using the DIASU® digital baropodometric scanning system and Milletrix software. Analyses will be performed under both barefoot and insole conditions, before and after the 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 31 Jul 2025.
- Individual participant dataSharing planned: No. There is currently no plan to share individual participant data (IPD) due to the study's limited scope and ethical considerations. Data sharing might be considered in the future upon justified request and with appropriate ethical approval.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Textured lateral wedge insole and Use of lateral wedge flat insole in people with Knee Osteoarthritis, run by Esra Nur Turkmen.
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 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: opening soon, as of the sponsor's last update on 31 Jul 2025. 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 Esra Nur Türkmen, PT, PhD (+90 554 523 98 30, e.nur5313@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 30-Second Chair Stand Test Performance (time frame: 8 weeks). The study lists 9 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 31 Jul 2025.