Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000154303
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
30/01/2017
Date last updated
11/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Factors associated with risk of falling among individuals with knee osteoarthritis
Scientific title
Factors associated with risk of falling among adults with knee osteoarthritis: a cross sectional study
Secondary ID [1] 290938 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 301661 0
Falls 301795 0
Condition category
Condition code
Musculoskeletal 301369 301369 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This research will identify the factors that contribute to falling among adults with knee osteoarthritis (OA). The study will explore the relationship between falls in adults with knee OA and clinical characteristics of knee OA such as pain, instability, physical function, muscle strength and balance. Participants will attend a session of up to 45 minutes to assess the knee, answer questionnaires, and perform standard tests for balance, strength and physical function.
Intervention code [1] 296875 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300765 0
In this study, history of falls will be the outcome variable. A fall is defined as an event in which person unintentionally comes to rest on the ground or other lower level. Following the National Institute for Health Care Excellence (NICE) guidelines and Health Quality and Safety Commission New Zealand (HQSC-NZ) recommendation on assessing falls in older people, participants will be asked the following questions:
(1) Have you slipped, tripped or fallen in the last year? If yes, how many fall/s?
(2) Can you get out of a chair without using your hands?
(3) Have you avoided some activities because you are afraid you might lose your balance?
Timepoint [1] 300765 0
Baseline assessment
Secondary outcome [1] 330811 0
Independent variables:
(1) Knee pain and function using Knee injury and Osteoarthritis Outcome Score (KOOS),

Timepoint [1] 330811 0
Baseline assessment
Secondary outcome [2] 331093 0
Independent variables:
(2) Knee instability using a question from the Knee Outcome Survey – Activities of Daily Living Scale will be used in measuring knee instability.
Timepoint [2] 331093 0
Baseline assessment
Secondary outcome [3] 331094 0
Independent variables:
(3)Postural balance and sway using NeuroCom SMART EquiTest system
Timepoint [3] 331094 0
Baseline assessment
Secondary outcome [4] 331095 0
Independent variables:
(4) Knee muscle strength using hand held dynamometer (Nicholas MMT, Model 01160)
Timepoint [4] 331095 0
Baseline assessment
Secondary outcome [5] 331096 0
Independent variables:
(5) Physical performance measure: Timed Up and Go test
Timepoint [5] 331096 0
Baseline assessment

Eligibility
Key inclusion criteria
Participants aged 18 years old and above with knee OA meeting the clinical criteria of the American College of Rheumatology will be recruited. Participants will be included whether they have a history of falls or not.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include the presence of another concomitant lower extremity musculoskeletal condition, inflammatory arthritis, the presence of neurological diseases, previous history of lower limb joint replacement, the presence of cognitive deficits, and those with a vestibular problem.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be used to characterize the participants in the study, distinguishing between those with and those without a history of falls. Mean and standard deviation will be calculated for continuous data such as knee pain, physical function, muscle strength and balance, while frequencies and proportions will be used for categorical data such as knee instability.

The student t test and chi-square test will be used to test for differences between the variables of those who fell, and those who did not fall. A p-value of 0.05 or less in two-sided testing will be used as criteria for statistically significant difference.

Logistic regression, computing for odds ratios (OR) point estimates and 95% confidence limits, will be used to estimate the association between the binary dependent variable, history of falling, and the hypothesized risk factors, confounders and effect modifiers. The hypothesized risk factors are knee pain, instability, physical function, muscle strength and balance. Potential confounders include age, sex and body mass index (BMI). Simple logistic regression will be done to determine the association of each independent variable with the outcome. Multiple logistic regressions using backward elimination of variables starting with the full model, and subsequently assessing variable deletion beginning with the biggest p-values (p-value criterion) will be utilized.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2017
Actual
15/04/2017
Date of last participant enrolment
Anticipated
Actual
16/10/2017
Date of last data collection
Anticipated
Actual
15/11/2017
Sample size
Target
72
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 8582 0
New Zealand
State/province [1] 8582 0
Otago

Funding & Sponsors
Funding source category [1] 295356 0
University
Name [1] 295356 0
University of Otago- School of Physiotherapy Mark Steptoe Memorial Trust Research Grant-in-aid
Country [1] 295356 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Centre for Health, Activity and Rehabilitation Research
School of Physiotherapy, University of Otago
325 Great King St, North Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 294182 0
None
Name [1] 294182 0
Address [1] 294182 0
Country [1] 294182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296688 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 296688 0
University of Otago
362 Leith St, North Dunedin, Dunedin 9016
Ethics committee country [1] 296688 0
New Zealand
Date submitted for ethics approval [1] 296688 0
10/10/2016
Approval date [1] 296688 0
21/10/2016
Ethics approval number [1] 296688 0
H16/120

Summary
Brief summary
The aim of the study is to determine the relationship between falls in adults with knee OA and clinical characteristics of knee OA such as pain, instability (giving way), physical function, muscle strength and balance. Participants aged 18 years old and above with knee OA meeting the clinical criteria of the American College of Rheumatology will be recruited from the community. Participants will be included whether they have a history of falls or not. Exclusion criteria will include the presence of another concomitant lower extremity musculoskeletal condition, inflammatory arthritis, the presence of neurological diseases, previous history of lower limb joint replacement, the presence of cognitive deficits, and those with a vestibular problem.

In this cross-sectional study, history of falls will be the outcome variable while pain, instability (giving way), physical function, muscle strength and balance. These variables will be measured by the Knee injury and Osteoarthritis Outcome Score (KOOS), Knee Outcome Survey – Activities of Daily Living Scale, Sensory Organization Test (SOT) using NeuroCom SMART Equitest system, hand held dynamometer and Timed Up and Go Test (TUG).

The proposed study will be clinically relevant since identification and relationship of risk factors for falls among a knee OA population will help physiotherapists and other healthcare providers identify individuals at risk of falling. It will help in the creation of effective prevention strategies that focus on modifiable factors which may decrease future risk of falls. The results of the study will contribute evidence to clarify possible underlying mechanisms of the risk factors for falls in a knee OA population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71786 0
Mr Donald Manlapaz
Address 71786 0
School of Physiotherapy
University of Otago
325 Great King St, North Dunedin, Dunedin 9016
Country 71786 0
New Zealand
Phone 71786 0
+64 22 436 4444
Fax 71786 0
Email 71786 0
[email protected]
Contact person for public queries
Name 71787 0
Mr Donald Manlapaz
Address 71787 0
School of Physiotherapy
University of Otago
325 Great King St, North Dunedin, Dunedin 9016
Country 71787 0
New Zealand
Phone 71787 0
+64 22 436 4444
Fax 71787 0
Email 71787 0
[email protected]
Contact person for scientific queries
Name 71788 0
Mr Donald Manlapaz
Address 71788 0
School of Physiotherapy
University of Otago
325 Great King St, North Dunedin, Dunedin 9016
Country 71788 0
New Zealand
Phone 71788 0
+64 22 436 4444
Fax 71788 0
Email 71788 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFactors associated with risk of falling in adults with knee osteoarthritis: A crosssectional study.2018https://dx.doi.org/10.1136/annrheumdis-2018-eular.4388
N.B. These documents automatically identified may not have been verified by the study sponsor.