Effects of Textured Insoles on Balance, Physical Performance, and Plantar Pressure in Older Adults With Knee Osteoarthritis (TIKOA)

Esra Nur Turkmen

Status: Not yet enrolling

Conditions: Knee Osteoarthritis

Treatments: Device: Use of lateral wedge flat insole; Device: Textured lateral wedge insole

Study type: Interventional

Funder types: Other

Identifiers

NCT07097649

LHU-TEXTINSOLE-2025-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 65 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Textured insoles group

Experimental group

Description:

Participants will use textured insoles for 8 weeks.

Treatment:

Device: Textured lateral wedge insole

Lateral wedge flat insoles group

Active Comparator group

Description:

The researchers will use flat insoles with lateral wedges for 8 weeks.

Treatment:

Device: Use of lateral wedge flat insole