NCT Number: NCT07097649
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.
Trial opening soon.
Get Notified65 year–75 year
All sexes
Interventional
Not applicable
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Lateral wedge textured insole
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Esra Nur Turkmen
Other
Investigation of the Effects of Lateral Wedge Textured Insoles on Balance, Physical Performance, and Plantar Pressure Distribution in Older Adults With Medial Knee Osteoarthritis
Acronym: TIKOA
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