NCT02314715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

December 2, 2014

Last Update Submit

March 2, 2015

Conditions

Osteoarthritis Knee

Keywords

Osteoarthritis Knee

Outcome Measures

Primary Outcomes (1)

  • Neuromuscular Control

    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

    1 day

Secondary Outcomes (1)

  • Disease Outcome

    1 day

Other Outcomes (1)

  • Determinants of knee osteoarthritis

    1 day

Study Arms (2)

Knee Osteoarthritis

Participants with diagnosed knee osteoarthritis

Controls

Participants without knee osteoarthritis

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary and secondary care clinics, and general community.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glasgow Caledonian University

Glasgow, G4 0BA, United Kingdom

Location

Related Publications (1)

  • Smith SL, Allan R, Marreiros SP, Woodburn J, Steultjens MPM. Muscle Co-Activation Across Activities of Daily Living in Individuals With Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2019 May;71(5):651-660. doi: 10.1002/acr.23688.

    PMID: 29953745DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Stephanie L Smith, MRes

    Glasgow Caledonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Musculoskeletal Health

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 11, 2014

Study Start

November 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations

GB(1)