Investigation of the Effects of Lateral Wedge Textured Insoles on Balance, Physical Performance, and Plantar Pressure Distribution in Older Adults With Medial Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 主要终点
- Change in 30-Second Chair Stand Test Performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No parties were masked due to the nature of the intervention.
入排标准
- 年龄范围
- 65 Years 至 75 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Textured insoles group
Participants will use textured insoles for 8 weeks.
干预措施: Textured lateral wedge insole (Device)
Lateral wedge flat insoles group
The researchers will use flat insoles with lateral wedges for 8 weeks.
干预措施: Use of lateral wedge flat insole (Device)
结局指标
主要结局
Change in 30-Second Chair Stand Test Performance
时间窗: 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 Step Test Performance
时间窗: 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 Timed Up and Go (TUG) Test Performance
时间窗: 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 Static Balance Score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Esra Nur Turkmen
PhD Lecturer, Principal Investigator - Department of Physiotherapy and Rehabilitation, KSÜ
Kahramanmaras Sutcu Imam University