- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02314715
Neuromuscular Control in Knee Osteoarthritis (NEKO)
March 2, 2015 updated by: Martijn Steultjens
Arthritis is one of the most prevailing causes of disability with knee osteoarthritis (KOA) the most common form.
The lifetime risk of developing symptomatic KOA by the age of 85 years is 44.7%,
where females are at a greater risk (1.8 times) than male counter parts.
KOA is the leading cause of limitations in activities of daily living such as walking and climbing stairs particularly in the elderly.
This is primarily due to pain and instability of the joint resulting in buckling of knees caused by muscle weakness, joint stiffness and damage.
Patients with KOA have larger variations in muscle strength and are unable to maintain a target force combined with impaired ability to perceive joint movement and positioning suggests impaired neuromuscular control (NC) may influence KOA.
NC refers to the nervous system's control over muscle activation contributing to task performance.
This study aims to establish the role of loss of NC in biomechanical determinants and health outcomes of KOA.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
95
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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Glasgow, United Kingdom, G4 0BA
- Glasgow Caledonian University
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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
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary and secondary care clinics, and general community.
Description
Inclusion Criteria:
Knee osteoarthritis participants only:
- Knee Osteoarthritis confirmed by a physician using the American College of Rheumatology (ACR 1986) Criteria
- Have unilateral or bilateral knee osteoarthritis
- Aged 40 years or over.
Healthy control participants only:
- Have no history of unilateral/bilateral knee osteoarthritis
- Had no current chronic/stable knee pain in the past 3 months
- Aged 40 years or over.
Exclusion Criteria:
All participants are excluded if they:
- Have neuromuscular skeletal injury/illness (e.g.Multiple Sclerosis, Parkinson's disease, Muscular Dystrophy, Cerebral Palsy)
- Have had knee surgery, knee arthroplastic surgery and arthroscopic debridement or corrective surgery for knee osteoarthritis in the past 12 months
- Have had corticosteroid injections to or around the knee in the past 3 months.
- Have unstable heart disease
- Previously had a stroke
- Have insulin-dependent diabetes
- Have osteoporosis
- Have a history of falls and other motor deficits
- Are unable to walk up and down stairs
- Are unable to rise from a chair without the aid of another person
- Have an unstable medication schedule and medication that causes dizziness
- Have Dementia/Alzheimer's/ an inability to comprehend, follow instructions and give informed consent
- Have an inability to lie flat for 60 minutes Have mental in their body.
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
Cohorts and Interventions
Group / Cohort |
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Knee Osteoarthritis
Participants with diagnosed knee osteoarthritis
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Controls
Participants without knee osteoarthritis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuromuscular Control
Time Frame: 1 day
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Neuromuscular control will be assessed through muscle co-activation index from electromyography (EMG) of the hamstrings, quadriceps and gastrocnemius.
The electromechanical delay (delay between the onset of EMG and force), active proprioception and force accuracy and steadiness measure determined from submaximal isometric contractions will be used to determine neuromuscular control
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease Outcome
Time Frame: 1 day
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Joint damage scored using the Boston Leeds Osteoarthritis Knee Score (BLOKS) from 1.5T MRI along with pain and function assessed from knee injury and osteoarthritis score (KOOS) and patient reported outcomes measurement information system (PROMIS) will be used to determine disease outcome.
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1 day
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determinants of knee osteoarthritis
Time Frame: 1 day
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Muscle strength (peak force) will be assessed from maximal isometric contractions of the knee, along with passive motion and position sense proprioception as determinants of knee osteoarthritis.
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephanie L Smith, MRes, Glasgow Caledonian University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2013
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2015
Study Registration Dates
First Submitted
December 2, 2014
First Submitted That Met QC Criteria
December 9, 2014
First Posted (Estimate)
December 11, 2014
Study Record Updates
Last Update Posted (Estimate)
March 3, 2015
Last Update Submitted That Met QC Criteria
March 2, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCU_MSK_SS_001
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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