Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Textured insoles group | Experimental | Participants will use textured insoles for 8 weeks. |
|
| Lateral wedge flat insoles group | Active Comparator | The researchers will use flat insoles with lateral wedges for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esra Nur TĂ¼rkmen, PT, PhD | Contact | +90 554 523 98 30 | e.nur5313@hotmail.com |
Not provided
Not provided
Not provided
Not provided
| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
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.
Not provided
Not provided
No parties were masked due to the nature of the intervention.
Not provided
|
|
| 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. |
|
| 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 |
| D012216 |
| Rheumatic Diseases |