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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04629040
• Other study ID #: CMUH109-REC1-129
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2020
• Est. completion date: July 2021

Study information

• Verified date: January 2021
• Source: China Medical University Hospital
• Contact: Wei-Ching Hsu
• Phone: +8860976517969
• Email: hsuwc7117[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Lateral wedge insole
Lateral wedge insole for knee osteoarthritis patient
• Ordinary insole
Ordinary insole

Locations

Country	Name	City	State
Taiwan	Asia University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in foot pressure at week 12	Investigators would use pressure insole to detect foot pressure of participants at baseline and 12 weeks after dressing insole	Baseline and week 12
Primary	Change from baseline in quadriceps thickness at week 4, week 8 and week 12	Investigators 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	Baseline, week 4, week 8 and week 12