- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03628508
Muscle Property, Alignment and Joint Loading in People With Knee Osteoarthritis
August 24, 2021 updated by: The Hong Kong Polytechnic University
External Tibia Torsion and Passive Muscle Stiffness of Quadriceps as Two Important Contributors of Joint Loading During Walking in People With Knee Osteoarthritis
Knee osteoarthritis (KOA) is a common chronic painful musculoskeletal condition among older adults.
It poses great challenge to the health care system due to its inability to be cured.
Understanding factors associated with disease progression in KOA should assist the development of novel prevention/rehabilitation strategies.
This study investigate factors including muscle properties, lower limb alignment and joint loading in patients with knee osteoarthritis before and after a six-week exercise program.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- Queen Mary Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 50-80
- having radiographic tibiofemoral joint OA in the medial compartment defined as Kellgren and Lawrence grade = 2 to 3
- having medial knee pain on most days of the month
- having a minimum average pain score of 2 on an 11-point numerical rating scale in the past week while walking
Exclusion Criteria:
- having lateral tibiofemoral compartment osteophytes greater than the medial side.
- having undergone intra-articular corticosteroid injection or knee surgery to either knee within the past 3 months
- having a systemic arthritic condition (e.g., rheumatoid arthritis)
- having a knee joint replacement or high tibial osteotomy in the past
- having any other muscular, joint or neurological condition influencing lower limb function
- unable to walk unaided
- having low back, hip, ankle or foot pain > 3 on numerical rating scale
- having a body mass index (BMI) >36 kg/ m2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Exercise
Six-week exercise including stretching, strengthening, endurance and gait modification
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Comprehensive exercise program including strengthening, stretching, gait modification etc.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of External Knee Adduction Moment as Assessed by Visual Motion Analysis System
Time Frame: At baseline and one week after intervention
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External knee moment in the frontal plane during early stance phase of walking
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At baseline and one week after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of Pain Severity Score as Assessed by Knee Injury and Osteoarthritis Outcome Score
Time Frame: At baseline and one week after intervention
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Pain intensity measured by the pain subscale of Knee injury and Osteoarthritis Outcome Score (KOOS).
The minimum value is 0 and maximum value is 100.
The higher scores mean a better outcome.
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At baseline and one week after intervention
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Tibial Torsion as Assessed by X-ray Imaging
Time Frame: At baseline
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The angle between tibial and femur in the transverse plane
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At baseline
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Change of Young's Modulus of Quadriceps as Assessed by Ultrasound Elastography
Time Frame: At baseline and one week after intervention
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Young's modulus by ultrasound elastography
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At baseline and one week after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Siu Ngor Fu, PhD, The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
August 6, 2018
First Submitted That Met QC Criteria
August 9, 2018
First Posted (Actual)
August 14, 2018
Study Record Updates
Last Update Posted (Actual)
September 16, 2021
Last Update Submitted That Met QC Criteria
August 24, 2021
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20170406003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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