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Neuromuscular Control in Knee Osteoarthritis (NEKO)

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ClinicalTrials.gov Identifier: NCT02314715
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Martijn Steultjens, Glasgow Caledonian University

Tracking Information
First Submitted Date December 2, 2014
First Posted Date December 11, 2014
Last Update Posted Date March 3, 2015
Study Start Date November 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 9, 2014)
Neuromuscular Control [ Time Frame: 1 day ]
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02314715 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 9, 2014)
Disease Outcome [ Time Frame: 1 day ]
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 9, 2014)
Determinants of knee osteoarthritis [ Time Frame: 1 day ]
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Neuromuscular Control in Knee Osteoarthritis
Official Title Neuromuscular Control in Knee Osteoarthritis
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary and secondary care clinics, and general community.
Condition Osteoarthritis Knee
Intervention Not Provided
Study Groups/Cohorts
  • Knee Osteoarthritis
    Participants with diagnosed knee osteoarthritis
  • Controls
    Participants without knee osteoarthritis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 2, 2015)
95
Original Estimated Enrollment
 (submitted: December 9, 2014)
130
Actual Study Completion Date February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT02314715
Other Study ID Numbers GCU_MSK_SS_001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Martijn Steultjens, Glasgow Caledonian University
Study Sponsor Martijn Steultjens
Collaborators Not Provided
Investigators
Principal Investigator: Stephanie L Smith, MRes Glasgow Caledonian University
PRS Account Glasgow Caledonian University
Verification Date March 2015