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Trial registered on ANZCTR


Registration number
ACTRN12619000167167
Ethics application status
Approved
Date submitted
17/01/2019
Date registered
5/02/2019
Date last updated
17/11/2021
Date data sharing statement initially provided
5/02/2019
Date results provided
17/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Gait patterns and gaze tracking in Osteoarthritis: A pilot study
Scientific title
Investigating the impact of osteoarthritis (OA) on individual’s gait patterns and gaze behaviour
Secondary ID [1] 297093 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GTS (Gaze Tracker Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 311108 0
Condition category
Condition code
Musculoskeletal 309738 309738 0 0
Osteoarthritis

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Group 1 - Osteoarthritis patients:
Informed consent
ROM - Flexion and extension of hip and knee
Isometric strength testing - Flexion and extension of hip and knee
Eye tracker activities - Average no. of fixations, Average duration of fixations, No. of changes
in locations, Average duration of final fixations, Average location of final fixations, Eye-Tracker Accuracy (%) & Calibration Points
Questionnaires - Oxford Knee Score (OKS), WOMAC, IPAQ, AAS, HFQ, RFG, NPR & LEF

Group 2 - Non-osteoarthritis patients (One set >50yo and one set <35yo):
Informed consent
ROM - Flexion and extension of hip and knee
Isometric strength testing - Flexion and extension of hip and knee
Eye tracker activities - Average no. of fixations, Average duration of fixations, No. of changes
in locations, Average duration of final fixations, Average location of final fixations, Eye-Tracker Accuracy (%) & Calibration Points
Questionnaires - Oxford Knee Score (OKS), WOMAC, IPAQ, AAS, HFQ, RFG, NPR & LEF

a) The people administering the session testing will be two medical students and two sports scientists from the James Cook University
b) The duration of each session will be between 1-2hours dependent on participant speed
c) Two sessions will be undertaken in the study: One session 2-6weeks pre-surgery and a secondary session 4-10 days after the first session
d) Materials used in the study will be: eye-tracking software, dynamometer, goniometer, strap to stabilise dynamometer, step & a chair
e) The eye tracker activities will involve: bilateral stance on a hard floor, bilateral stance on a foam pad, single leg stances for as long as possible, timed up and go test, 3 cone agility test, walking over a step, walking up and down 3 steps, walking 30m normally, walking 30m with a cup of water in hand, walking 30m whilst subtracting 7 from 100, picking up an object from the floor and a gait test
Intervention code [1] 313367 0
Not applicable
Comparator / control treatment
The control groups will be of two age categories who are healthy and do not have any signs or symptoms of Osteoarthritis
Control group
Active

Outcomes
Primary outcome [1] 318699 0
Examine the reproducibility of a novel, hand-held digital dynamometer (HHD) in individuals with osteoarthritis, their age-matched, apparently healthy counterparts and younger adults (i.e. younger than or equal to 35 years old)

The HHD will be assessed by measuring the force created from four isometric strength tests: flexion and extension of the hip and knee
Timepoint [1] 318699 0
1. Session 1 - 2-6 weeks prior to surgery
Session 2 - 4-10 days after first session (Primary endpoint)

2. Healthy controls first session will be whenever is appropriate for them and the examiner but the second session will 4-10 days after the first session
Primary outcome [2] 318700 0
Reproducibility of an eye-tracking device in individuals with osteoarthritis, their age-matched, apparently healthy counterparts and younger adults (i.e. younger than or equal to 35 years old)

Over the two sessions the eye tracking software will be used in activities as mentioned in the previous page


To determine whether the level of physical activity, psychosocial measures (i.e., fear of falls) and physical measures (i.e., muscular strength, balance and walking capacity) are associated with gaze behaviour characteristics.
Timepoint [2] 318700 0
1. Session 1 - 2-6 weeks prior to surgery
Session 2 - 4-10 days after first session (Primary endpoint)

2. Healthy controls first session will be whenever is appropriate for them and the examiner but the second session will 4-10 days after the first session
Secondary outcome [1] 365774 0
To determine whether the level of physical activity are associated with gaze behaviour characteristics

Questionnaires filled out 48-72hours prior to session 1 will be used to correlate to the gaze behaviours measured in sessions 1 and 2

Questionnaires used:
International Physical Activities Questionnaires
Active Australia Survey
Lower Extremity Function
Timepoint [1] 365774 0
Questionnaires 48-72 hours prior to session 1

Session 1 - 2-6 weeks prior to surgery
Session 2 - 4-10 days after first session

2. Healthy controls first session will be whenever is appropriate for them and the examiner but the second session will 4-10 days after the first session
Secondary outcome [2] 366164 0
To determine whether the level of psychosocial measures (i.e., fear of falls) are associated with gaze behaviour characteristics

Questionnaires filled out 48-72hours prior to session 1 will be used to correlate to the gaze behaviours measured in sessions 1 and 2

Questionnaires used:
History of Falls Questionnaire
Risk of Falls Questionnaire
Timepoint [2] 366164 0
Questionnaires 48-72 hours prior to session 1

Session 1 - 2-6 weeks prior to surgery
Session 2 - 4-10 days after first session

2. Healthy controls first session will be whenever is appropriate for them and the examiner but the second session will 4-10 days after the first session
Secondary outcome [3] 366165 0
To determine whether the level of physical measures (i.e., muscular strength, balance and walking capacity) are associated with gaze behaviour characteristics

Questionnaires filled out 48-72hours prior to session 1 will be used to correlate to the gaze behaviours measured in sessions 1 and 2

Questionnaires used:
Oxford Knee Score
Western Ontario and McMaster Universities Osteoarthritis Index
Numeric Pain Rating
Timepoint [3] 366165 0
Questionnaires 48-72 hours prior to session 1

Session 1 - 2-6 weeks prior to surgery
Session 2 - 4-10 days after first session

2. Healthy controls first session will be whenever is appropriate for them and the examiner but the second session will 4-10 days after the first session
Secondary outcome [4] 366166 0
To compare the gaze behaviour between individuals with osteoarthritis, their age-matched, apparently healthy counterparts, and younger adults, whilst performing activities of daily living

Gaze behaviour will be monitored with the use of eye-tracking software - A camera is placed on a pairs of glasses to monitor the eye
Timepoint [4] 366166 0
Session 1 - 2-6 weeks prior to surgery
Session 2 - 4-10 days after first session

Eligibility
Key inclusion criteria
Inclusion specifically for OA group:
Patients scheduled to undergo unilateral or bilateral primary joint replacement for primary arthritis of the respective joint, with radiographic evidence of the need for arthroplasty.
**Prior surgical intervention on the affected joint is not considered an exclusion criterion for this study if >12 months prior, previous history to be documented
- Over the age of 35y

Inclusion for OA and Control groups:
- Normal central and peripheral neurological function
- Able to stand independently for at least 30 minutes and walk independently without an assistive device
- No history of vestibular disease and no evidence or history of dementia
- Male and female
- Able to provide informed consent
- BMI less than or equal to 40
- Patient capable of undergoing 2-hour assessment at nominated time points
- Contact lenses

Inclusion for young control:
Less than 35y

Inclusion for 0lder control:
Older than 50y
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Patients unable to comply with assessment requirements
- Patients unable to provide informed consent
- Any serious medical condition other than OA
- Use of drug that might affect balance such as benzodiazepines
- History or evidence of neurological deficit such as previous stroke or muscle disease
- History or evidence of orthopaedic, muscular or psychological problems which may affect task performance during the study
- Patients with BMI greater than 40
- Patients with active infection
- Patients with significant other orthopaedic deformities, anatomical disruption/distortion of the joint other than that caused by OA.
- Previous joint replacement or alignment correction or stabilization surgery (alignment or minor soft tissue procedure < 12 months)
- Visual impairment or compromised visual acuity (VA) (VA is defined by one’s ability to perform function of ‘generic’ walking such as walk in a straight line, around stationary objects and over a step. Compromised VA; without glasses your VA is impaired)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
According to an a priori sample size calculation, these participant numbers were sufficient to generate significant, inter-individual differences in the dependent measures with the power set at 80% and alpha level at 0.05, based on previous studies (Ambati, Saucedo, Murray, Powell, & Reed-Jones, 2016; Yamada et al., 2012). The apparently healthy, older adults will be treated as controls and their measures will be compared against the groups with osteoarthritis, whereas data obtained from the younger adults will be used for normalisation.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/02/2019
Actual
5/02/2019
Date of last participant enrolment
Anticipated
1/03/2021
Actual
30/03/2020
Date of last data collection
Anticipated
31/03/2021
Actual
30/03/2020
Sample size
Target
60
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12925 0
Mater Hospital Pimlico - Pimlico
Recruitment postcode(s) [1] 25400 0
4810 - Pimlico

Funding & Sponsors
Funding source category [1] 301660 0
Other
Name [1] 301660 0
Orthopaedic Research Institutde of Queensland (ORIQL)
Country [1] 301660 0
Australia
Primary sponsor type
Other
Name
Orthopaedic Research Institutde of Queensland (ORIQL)
Address
7 Turner St, Pimlico QLD 4812
Country
Australia
Secondary sponsor category [1] 301383 0
None
Name [1] 301383 0
Address [1] 301383 0
Country [1] 301383 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302380 0
Mater Health Services North Queensland Human Research Ethics Committee
Ethics committee address [1] 302380 0
Ethics committee country [1] 302380 0
Australia
Date submitted for ethics approval [1] 302380 0
Approval date [1] 302380 0
13/01/2019
Ethics approval number [1] 302380 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90030 0
Dr Jonathan Connor
Address 90030 0
James Cook University
1 James Cook Dr,
Douglas QLD 4814
Country 90030 0
Australia
Phone 90030 0
+61 747816550
Fax 90030 0
Email 90030 0
jonathan.connor@jcu.edu.au
Contact person for public queries
Name 90031 0
Andrea Grant
Address 90031 0
ORIQL
7 Turner Street
Pimlico
QLD 4812
Country 90031 0
Australia
Phone 90031 0
+61 413 685 331
Fax 90031 0
Email 90031 0
research_coordinator@oriql.com.au
Contact person for scientific queries
Name 90032 0
Andrea Grant
Address 90032 0
ORIQL
7 Turner Street
Pimlico
QLD 4812
Country 90032 0
Australia
Phone 90032 0
+61 413 685 331
Fax 90032 0
Email 90032 0
research_coordinator@oriql.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.