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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02314715
Other study ID # GCU_MSK_SS_001
Secondary ID
Status Completed
Phase N/A
First received December 2, 2014
Last updated March 2, 2015
Start date November 2013
Est. completion date February 2015

Study information

Verified date March 2015
Source Glasgow Caledonian University
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 95
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 40 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United Kingdom Glasgow Caledonian University Glasgow

Sponsors (1)

Lead Sponsor Collaborator
Martijn Steultjens

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Determinants of knee osteoarthritis 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. 1 day No
Primary 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 No
Secondary Disease Outcome 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. 1 day No
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