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

NCT07097649 | Not Yet Recruiting

• 1 other identifier: LHU-TEXTINSOLE-2025-01
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Knee Osteoarthritis

Keywords

Medial Compartment Knee Osteoarthritis; Textured Insoles; Balance; Plantar Pressure; Physical Performance

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  8 weeks

Study Arms (2)

Textured insoles group

EXPERIMENTAL

Participants will use textured insoles for 8 weeks.

Device: Textured lateral wedge insole

Lateral wedge flat insoles group

ACTIVE COMPARATOR

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

Device: Use of lateral wedge flat insole

Interventions

Textured lateral wedge insole DEVICE

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.

Also known as: Lateral wedge textured insole

Textured insoles group

Use of lateral wedge flat insole DEVICE

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.

Lateral wedge flat insoles group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Esra Nur Turkmen: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Esra Nur Türkmen, PT, PhD

CONTACT

+90 554 523 98 30; e.nur5313@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No parties were masked due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Lecturer, Principal Investigator - Department of Physiotherapy and Rehabilitation, KSÜ

Model Details: 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.

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 31, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share