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The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed

The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04629040
Enrollment
40
Registered
2020-11-16
Start date
2020-11-13
Completion date
2021-07-31
Last updated
2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief summary

Investigators would let knee osteoarthritis patient dressing lateral wedge insole and evaluate the effect for foot pressure modification, quadriceps thickness detected with ultrasound and gait. Investigators would made the patient in control group dressing ordinary insole.

Detailed description

Knee osteoarthritis is one of the most popular disease affected elderly people and made them discomfort. There was no study using foot pressure as a parameter about lateral wedge insole intervention for the knee osteoarthritis patient. The purpose of this study was to investigate the effect of lateral wedge insole for the patient of knee osteoarthritis. During total period of 12 weeks for the study, investigators randomized the patient into experimental and control group. Then investigators evaluated the patient's foot pressure, quadriceps thickness, stride length, stride width, walking speed, pain scale and daily function before intervention, 4th weeks, 8th weeks and 12th weeks. Investigators would use pressure insole designed in the Industrial Technology Research Institute in Taiwan. The portable device used in this study maybe suitable for evaluation of other lower limb disease. There were studies evaluating elderly people dysfunction, critical illness muscle atrophy or knee joint disease with ultrasound detected quadriceps thickness. But there was no study about the correlation between foot pressure and quadriceps thickness for evaluating the effect of lateral wedge insole. Investigators hoped to make a new model for evaluating lower limbs disorder in the future.

Interventions

Lateral wedge insole for knee osteoarthritis patient

OTHEROrdinary insole

Ordinary insole

Sponsors

China Medical University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Knee osteoarthritis patients * Medial knee pain

Exclusion criteria

* Unable to walk independently * Ambulation with device * Any neurologic disease * Rheumatoid arthritis, gouty arthritis * History of lower limbs fracture * History of operation for lower limbs * Any infectious disease

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in foot pressure at week 12Baseline and week 12Investigators would use pressure insole to detect foot pressure of participants at baseline and 12 weeks after dressing insole
Change from baseline in quadriceps thickness at week 4, week 8 and week 12Baseline, week 4, week 8 and week 12Investigators would use ultrasound to measure quadriceps thickness of participants at baseline, 4 weeks after dressing insole, 8 weeks after dressing insole and 12 weeks after dressing insole

Countries

Taiwan

Contacts

Primary ContactWei-Ching Hsu
hsuwc7117@gmail.com+8860976517969

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026