The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lateral wedge insole
Ordinary insole
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
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
Sites / Locations
- Asia University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04629040
First Posted
October 27, 2020
Last Updated
January 28, 2021
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04629040
Brief Title
The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Lateral wedge insole
Intervention Description
Lateral wedge insole for knee osteoarthritis patient
Intervention Type
Other
Intervention Name(s)
Ordinary insole
Intervention Description
Ordinary insole
Primary Outcome Measure Information:
Title
Change from baseline in foot pressure at week 12
Description
Investigators would use pressure insole to detect foot pressure of participants at baseline and 12 weeks after dressing insole
Time Frame
Baseline and week 12
Title
Change from baseline in quadriceps thickness at week 4, week 8 and week 12
Description
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
Time Frame
Baseline, week 4, week 8 and week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Ching Hsu
Phone
+8860976517969
Email
hsuwc7117@gmail.com
Facility Information:
Facility Name
Asia University Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Ching Hsu
Phone
+8860976517969
12. IPD Sharing Statement
Learn more about this trial
The Effect of Lateral Wedge Insole for Knee Osteoarthritis Patient in Plantar Pressure, Quadriceps Thickness, Gait and Walking Speed
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