Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04629040
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Lateral wedge insole Other: Ordinary insole Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 13, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Intervention Other: Lateral wedge insole
Lateral wedge insole for knee osteoarthritis patient

Placebo Comparator: Control Other: Ordinary insole
Ordinary insole




Primary Outcome Measures :
  1. Change from baseline in foot pressure at week 12 [ Time Frame: Baseline and week 12 ]
    Investigators would use pressure insole to detect foot pressure of participants at baseline and 12 weeks after dressing insole

  2. Change from baseline in quadriceps thickness at week 4, week 8 and week 12 [ Time Frame: Baseline, 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04629040


Contacts
Layout table for location contacts
Contact: Wei-Ching Hsu +8860976517969 hsuwc7117@gmail.com

Locations
Layout table for location information
Taiwan
Asia University Hospital Recruiting
Taichung, Taiwan
Contact: Wei-Ching Hsu    +8860976517969      
Sponsors and Collaborators
China Medical University Hospital
Layout table for additonal information
Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04629040    
Other Study ID Numbers: CMUH109-REC1-129
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases