ANZCTR - Registration

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 information initially 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]

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

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Observational

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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

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

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]

Mater Hospital Pimlico - Pimlico

Recruitment postcode(s) [1]

4810 - Pimlico

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Orthopaedic Research Institutde of Queensland (ORIQL)

Country [1]

Australia

Primary sponsor type

Other

Name

Orthopaedic Research Institutde of Queensland (ORIQL)

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Mater Health Services North Queensland Human Research Ethics Committee

Ethics committee address [1]

21-37 Fulham Road, Pimlico
QLD, 4812
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

13/01/2019

Ethics approval number [1]

Summary

Brief summary

Project summary - This project is a pilot study to examine whether the difference in psychosocial and physical measures are associated with gaze behaviour in individuals with OA and their younger healthier counterparts. The purpose of this research is to examine motor, cognitive and perceptual behaviours in individuals with OA; and, investigate whether the manifestation of these behaviours are associated with an increased risk of previous or future falls.

Hypothesis - The hypothesis of this project is that individuals with osteoarthritis will demonstrate compromised gait patterns, adverse gaze behaviour and poorer walking automaticity (normally found in healthy adults). The adverse gait patterns, gaze behaviour and inability to complete dual tasks while walking is also hypothesized to be linked with greater falls prevalence.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Jonathan Connor

Address

James Cook University
1 James Cook Dr,
Douglas QLD 4814

Country

Australia

Phone

+61 747816550

Email

[email protected]

Contact person for public queries

Name

Mrs Andrea Grant

Address

ORIQL
7 Turner Street
Pimlico
QLD 4812

Country

Australia

Phone

+61 413 685 331

Email

[email protected]

Contact person for scientific queries

Name

Mrs Andrea Grant

Address

ORIQL
7 Turner Street
Pimlico
QLD 4812

Country

Australia

Phone

+61 413 685 331

Email

[email protected]

Trial Review

Documents added manually

Documents added automatically