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Trial registered on ANZCTR


Registration number
ACTRN12620000994987
Ethics application status
Approved
Date submitted
7/08/2020
Date registered
6/10/2020
Date last updated
6/10/2020
Date data sharing statement initially provided
6/10/2020
Date results information initially provided
6/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of gait training on walking stability in people with Parkinson's disease
Scientific title
Effect of real-time feedback on walking stability in people with Parkinson's disease
Secondary ID [1] 301958 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson’s disease 318535 0
Condition category
Condition code
Neurological 316541 316541 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 316940 316940 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gait retraining.
The participant will receive real-time visual biofeedback regarding the frontal plane lean of their trunk as they walk along a level indoor walkway wearing their own closed-in footwear. The feedback will be projected onto a screen at the end of the walkway in the form of a moving line representing the magnitude of their trunk lean in real-time along with a shaded zone representing a target magnitude of lean they should try to avoid. Their baseline trunk lean will be calculated using marker-based three-dimensional motion analysis during normal walking. They will then be instructed to use this feedback to modify their movement patterns to reduce the magnitude of trunk lean as they walk by 30% from their average baseline mediolateral excursion (as represented by the shaded zone). This intervention will be facilitated by an Exercise Scientist/Biomechanist and delivered in a single session at the Biomechanics laboratory, Australian Catholic University, Brisbane, Queensland, will last 10-20 minutes and will be completed at a self-selected walking pace. Outcome data will be collected across two sessions, with Session 1 consisting of: (i) Baseline walking trials (at least 5 trials), (ii) walking trials during the delivery of the intervention (at least the last 5 trials of the intervention), (iii) 5 minutes post intervention (at least 5 trials), and Session 2 consisting of (iv) follow-up walking trials (at least 5 trials). The exact number of trials under each condition will be recorded manually by the session facilitator.
Intervention code [1] 318263 0
Rehabilitation
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324668 0
Mediolateral trunk lean (deg) [Change from baseline] calculated using marker-based three-dimensional motion analysis during walking.
Timepoint [1] 324668 0
Baseline; During intervention; 5 minutes post intervention; 1-week post-intervention. Primary timepoint comparison: Baseline versus 5 minutes post intervention.
Secondary outcome [1] 385369 0
Gait velocity (m/s) [Change from baseline] calculated using marker-based three-dimensional motion analysis during walking.
Timepoint [1] 385369 0
Baseline; During intervention; 5 minutes post intervention; 1-week post-intervention.
Secondary outcome [2] 385370 0
Stride length (m) [Change from baseline] calculated using marker-based three-dimensional motion analysis during walking.
Timepoint [2] 385370 0
Baseline; During intervention; 5 minutes post intervention; 1-week post-intervention.
Secondary outcome [3] 385371 0
Mediolateral head motion (cm and cm/m·s-1) [Change from baseline] calculated using marker-based three-dimensional motion analysis during walking.
Timepoint [3] 385371 0
Baseline; During intervention; 5 minutes post intervention; 1-week post-intervention.
Secondary outcome [4] 385372 0
Mediolateral trunk motion (cm and cm/m·s-1) [Change from baseline] calculated using marker-based three-dimensional motion analysis during walking.
Timepoint [4] 385372 0
Baseline; During intervention; 5 minutes post intervention; 1-week post-intervention.
Secondary outcome [5] 385373 0
Mediolateral pelvis motion (cm and cm/m·s-1) [Change from baseline] calculated using marker-based three-dimensional motion analysis during walking.
Timepoint [5] 385373 0
Baseline; During intervention; 5 minutes post intervention; 1-week post-intervention.
Secondary outcome [6] 385374 0
Centre of mass to base of support distance (cm) [Change from baseline] calculated using marker-based three-dimensional motion analysis during walking.
Timepoint [6] 385374 0
Baseline; During intervention; 5 minutes post intervention; 1-week post-intervention.

Eligibility
Key inclusion criteria
(a) diagnosis of PD by a neurologist according to the United Kingdom Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria (Hughes, Daniel, Kilford & Lees, 1992);
(b) presenting with PD-related symptoms ranging from stages 1-3 on the H&Y scale (Goetz et al, 2004).
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(a) significant surgery within the last three months that may influence walking;
(b) recurrent pain or injury affecting walking;
(c) an inability to walk without assistance (e.g. the use of handrails or a carer);
(d) significant visual (Bailey-Lovie high contrast visual acuity >0.30 logMAR)(Brown & Lovie-Kitchin, 1989) or cognitive impairment (Addenbrooke’s Cognitive Examination score of < 82 out of 100) (Mioshi, Dawson, Mitchell, Arnold & Hodges, 2006);
(e) has received deep brain stimulation;
(f) is greater than 80 years of age.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
The primary research question seeks to determine differences in the average mediolateral trunk lean between the 4-time points (i: Baseline walking; ii: Intervention; iii: Post-intervention; iv: 1-week follow up), using a Repeated Measures ANOVA.

Sample size was estimated using G-Power (Version 3.1.9.2) based on a Repeated Measures ANOVA study design. As no previous data was available regarding changes in mediolateral trunk lean, the default medium effect size was selected (ES = 0.25). For a significance level of 0.05 and power of 80% the estimated sample size is n=24. To account for participant drop out between sessions we will aim to recruit 30 participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 306382 0
University
Name [1] 306382 0
Australian Catholic University
Address [1] 306382 0
40 Edward Street, North Sydney NSW 2060
Country [1] 306382 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
40 Edward Street, North Sydney NSW 2060
Country
Australia
Secondary sponsor category [1] 306904 0
None
Name [1] 306904 0
Address [1] 306904 0
Country [1] 306904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306579 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [1] 306579 0
40 Edward Street, North Sydney NSW 2060
Ethics committee country [1] 306579 0
Australia
Date submitted for ethics approval [1] 306579 0
17/08/2018
Approval date [1] 306579 0
24/09/2018
Ethics approval number [1] 306579 0
2018-196H

Summary
Brief summary
The aim of this program is to reduce the risk of falls in people with Parkinson's disease using non-invasive technology to monitor and improve their walking balance. Falls are a major cause of hospitalisation in people with PD, with 60% of all sufferers experiencing a fall each year. There is strong evidence that fallers walk with greater side to side head movement along with shorter step length and a slower cadence than non-fallers. Improving gait stability by retraining the way these individuals walk may thus have great potential to reduce the risk of falls and consequently reduce fall-related hospitalisations.
A cross sectional study involving approximately 30 people with PD with mild to severe disease severity will be conducted. The effect of real-time feedback on walking mechanics will be investigated.
Participation in this research will require individuals to visit the school of Exercise Science's Biomechanics Laboratory at the Brisbane campus of the Australian Catholic University on two separate occasions separated by approximately 1 week to complete a series of walking assessments. During these assessments, walking mechanics will be evaluated using a 3-dimensional motion capture system. The protocol will involve each participant receiving real-time biofeedback.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104354 0
Dr Mark W. Creaby
Address 104354 0
School of Behavioural and Health Sciences, Faculty of Health Sciences, Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland, 4014.
Country 104354 0
Australia
Phone 104354 0
+61 7 36237587
Fax 104354 0
Email 104354 0
mark.creaby@acu.edu.au
Contact person for public queries
Name 104355 0
Dr Mark Creaby
Address 104355 0
School of Behavioural and Health Sciences, Faculty of Health Sciences, Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland, 4014.
Country 104355 0
Australia
Phone 104355 0
+61 7 36237587
Fax 104355 0
Email 104355 0
mark.creaby@acu.edu.au
Contact person for scientific queries
Name 104356 0
Dr Mark Creaby
Address 104356 0
School of Behavioural and Health Sciences, Faculty of Health Sciences, Australian Catholic University, 1100 Nudgee Road, Banyo, Queensland, 4014.
Country 104356 0
Australia
Phone 104356 0
+61 7 36237587
Fax 104356 0
Email 104356 0
mark.creaby@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a retrospective registration and IPD sharing was not covered as part of the ethics approval.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary