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

NCT ID: NCT04629040

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

Lateral wedge insole

Intervention Type OTHER

Lateral wedge insole for knee osteoarthritis patient

Control

Group Type PLACEBO_COMPARATOR

Ordinary insole

Intervention Type OTHER

Ordinary insole

Interventions

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Lateral wedge insole

Lateral wedge insole for knee osteoarthritis patient

Intervention Type OTHER

Ordinary insole

Ordinary insole

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asia University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Wei-Ching Hsu

Role: CONTACT

+8860976517969

Facility Contacts

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Wei-Ching Hsu

Role: primary

+8860976517969

Other Identifiers

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CMUH109-REC1-129

Identifier Type: -

Identifier Source: org_study_id

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