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Trial registered on ANZCTR


Registration number
ACTRN12618001515280
Ethics application status
Approved
Date submitted
8/08/2018
Date registered
10/09/2018
Date last updated
5/02/2021
Date data sharing statement initially provided
5/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
SAFE-PD - Stepping to Avoid Fall Events in Parkinson’s disease
Scientific title
Reactive and volitional step training to reduce risk of falling in people with Parkinson’s disease: A randomised controlled trial
Secondary ID [1] 295352 0
None
Universal Trial Number (UTN)
U1111-1216-4042
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 308566 0
Falls 308567 0
Condition category
Condition code
Neurological 307522 307522 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 307523 307523 0 0
Physiotherapy
Injuries and Accidents 308100 308100 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention group will receive volitional and reactive step training.

Volitional step training will involve playing home-based exergames for 12 weeks. The training involves a custom-built software, operating on a supplied personal computer and stepping mat. Stepping games will be used to train balance and step reaction time, as well as executive functions. A research assistant will visit each participant’s home to install the system and instruct how to use the equipment. Participants will also receive a follow-up home visit in the following week to ensure safe use and progression of training. Weekly training dose will progress from 40+m minutes in weeks 1-2, 60+ minutes in weeks 3-4 and 80+ minutes in weeks 5-12. The training will be recommended to be split between 3 or 4 sessions per week and will be monitored via data transfer to a web application. Participants who do not engage in the minimum weekly training dose for two consecutive weeks will be contacted by telephone to encourage adherence and also address any barriers to participation. Intensity and complexity of training will be progressed as performance improves by increasing the level of difficulty of the games. Additional visits and telephone support will be provided for those participants experiencing difficulties.

Reactive step training sessions will be undertaken in weeks 4 and 8. Participants will visit NeuRA to undertake two individual sessions (100 minutes in total). Each session focuses on balance recovery from mix of trips and slips. A novel trip- and slip-perturbation system built on a 10-m walkway consisting of 50cm x 50cm wooden decking tiles will be used. Participants will be secured with a ceiling-mounted full body harness to avoid any contact with the ground. Participants will practise recovering their balance to trip and slip events. Gait speed during this training will be approximately 80% (or 50 to 100% if adjustment is required) of usual speed using music or metronome with beat corresponding to target cadence. A slip is induced by a movable tile on two hidden low-friction rails with linear bearings that result in a slide of 10-70cm upon foot contact. A trip is induced using a 7-14cm height tripping board that flips up from the walkway at mid-swing using a foot detection sensor. An exercise physiologist and an assistant will supervise each reactive step training session, ensure participants safety, adherence and individualize the training protocol. The tripping board and the slipping tile are undetectable and can be moved to various locations along the walkway so that predictive adaptation (e.g. changing gait with prediction) will be minimized and reactive stepping responses can be specifically trained.
Intervention code [1] 301673 0
Rehabilitation
Comparator / control treatment
Participants allocated to the control group will be asked to maintain their usual daily activities.
Control group
Active

Outcomes
Primary outcome [1] 306501 0
Perturbation-induced falls incidence will be assessed on the slip and trip walkway (Okubo et al., 2018).
Timepoint [1] 306501 0
Baseline (week 1) and immediately after the intervention (week 14)
Primary outcome [2] 306502 0
The choice stepping reaction time test standard version (Lord et al., J Gerontol A Biol Sci Med Sci, 2001)
Timepoint [2] 306502 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [1] 348696 0
Real life fall incidence will be ascertained using monthly falls calendars or email (Lamb et al., J Am Geriatr Soc, 2005).
Timepoint [1] 348696 0
For 6 months from the baseline assessments
Secondary outcome [2] 348697 0
The choice stepping reaction time inhibitory version
Timepoint [2] 348697 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [3] 348698 0
The Stroop Stepping Test
(Schoene et al., Age Ageing, 2013)
Timepoint [3] 348698 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [4] 348700 0
The coordinated stability test
(Lord et al., J Am Geriatr Soc, 1996),
Timepoint [4] 348700 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [5] 348701 0
The Falls Efficacy Scale-International
(Yardley et al., 2005)
Timepoint [5] 348701 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [6] 348703 0
The gait adaptability test using projected obstacles and targets appearing at short notice on a walkway (Caetano et al., Gait Posture, 2016).
Timepoint [6] 348703 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [7] 348704 0
The Trail-making Test (Wechsler, 1981) will be assessed using an iPad app NeuRA Trails.
Timepoint [7] 348704 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [8] 348738 0
Postural sway on foam (Lord et al., J Am Geriatr Soc 1994). A sway meter that consists of a 40cm-long rod with a vertically mounted pen at its end will be attached at waist level.
Timepoint [8] 348738 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [9] 348739 0
Knee extension strength will be measured using a digital dynamometer attached to the participant's leg using a webbing strap and affixed to a crossbar position behind the participant (Lord et al., J Am Geriatr Soc 1994).
Timepoint [9] 348739 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [10] 348743 0
The simple reaction time test (Lord et al., J Am Geriatr Soc 1994). A hand-held electronic timer and a light as the stimulus and a switch will be used.
Timepoint [10] 348743 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [11] 348744 0
Haemodynamic changes in the brain, Prefrontal Cortex (Maidan et al., 2016) will be measured with functional near-infrared spectroscopy (fNIRS) while participants perform the volitional stepping and gait adaptability tests.
Timepoint [11] 348744 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [12] 349369 0
Haemodynamic changes in the brain, Supplementary Motor Area (Maidan et al., 2016) will be measured with functional near-infrared spectroscopy (fNIRS) while participants perform the volitional stepping and gait adaptability tests.
Timepoint [12] 349369 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [13] 349370 0
Haemodynamic changes in the brain, Primary Motor Cortex (Maidan et al., 2016) will be measured with functional near-infrared spectroscopy (fNIRS) while participants perform the volitional stepping and gait adaptability tests.
Timepoint [13] 349370 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [14] 349785 0
Margin of stability (Hof et al., 2005) during the slip and trip trials (baseline and post-intervention) will be assessed using the vicon 3D motion analysis system with the full-body 38-marker model..
Timepoint [14] 349785 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [15] 350582 0
Extrapolated centre of mass (Hof et al., 2005) during the slip and trip trials (baseline and post-intervention) will be assessed using the vicon 3D motion analysis system with the full-body 38-marker model..
Timepoint [15] 350582 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [16] 350583 0
Step length during the slip and trip trials will be assessed using the vicon 3D motion analysis system with the full-body 38-marker model..
Timepoint [16] 350583 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [17] 350584 0
Range of trunk sway during the slip and trip trials will be assessed using the vicon 3D motion analysis system with the full-body 38-marker model..
Timepoint [17] 350584 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [18] 350585 0
Arm movements during the slip and trip trials will be assessed using the vicon 3D motion analysis system with the full-body 38-marker model..

Timepoint [18] 350585 0
Baseline (week 1) and immediately after the intervention (week 14)
Secondary outcome [19] 350587 0
Ground reaction forces during the slip and trip trials will be measured using AMTI and Kistler force plates.
Timepoint [19] 350587 0
Baseline (week 1) and immediately after the intervention (week 14)

Eligibility
Key inclusion criteria
• Have been diagnosed with Parkinson’s disease (according to UK PD Society Brain Bank
Criteria);
• Being stable on anti-Parkinsonian medications for >= 1 month
• Living independently in the community or retirement village;
• Able to communicate in English language
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Severe disease stage (Hoehn & Yahr stage >3)
• Diagnosis of other neurological and/or significant cognitive impairments (Montreal Cognitive Assessment (MOCA) < 19)
• Atypical Parkinsonism
• Inability to stand or walk 30m without assistance
• Less than 6 months post deep brain stimulation surgery
• Medical conditions which would preclude physical assessment or training using perturbation (e.g. duodopa)
• History of 20+ falls in past 3 months.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of participants will not be conducted until the individual have been enrolled and completed the baseline assessment. Following the baseline assessment, research staff will access a web-based randomisation service to perform random allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random block size randomisation using a web-based randomisation service.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed with an intention-to-treat approach. The number of falls will be analysed using Poisson regression (laboratory falls) or negative binomial regression (real-life falls) to estimate the difference in fall rates between the groups. The proportion of fallers between groups will be compared using the relative risk statistic. General linear models will be used to assess the effect of group allocation on the continuously scored secondary outcome measures. Non-parametric tests will be used if the normality of distribution cannot be assumed.

Sample size calculation (with Poisson regression, significance levels of 0.05, power of 0.8, control falling rate of 70%, 10% dropouts) revealed that 44 eligible participants would need to be recruited initially (22 per group) for a significant reduction by 50% in the number of laboratory falls in the intervention group.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2018
Actual
11/09/2018
Date of last participant enrolment
Anticipated
29/03/2019
Actual
14/06/2019
Date of last data collection
Anticipated
30/09/2019
Actual
16/01/2020
Sample size
Target
44
Accrual to date
Final
44
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11262 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment postcode(s) [1] 23141 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 299949 0
Charities/Societies/Foundations
Name [1] 299949 0
Parkinson's NSW
Country [1] 299949 0
Australia
Funding source category [2] 299950 0
Government body
Name [2] 299950 0
National Health and Medical Research Council
Country [2] 299950 0
Australia
Primary sponsor type
Individual
Name
Prof Stephen Lord
Address
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 299324 0
Individual
Name [1] 299324 0
Dr. Jasmine Menant
Address [1] 299324 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [1] 299324 0
Australia
Secondary sponsor category [2] 299325 0
Individual
Name [2] 299325 0
Dr Daina Sturnieks
Address [2] 299325 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [2] 299325 0
Australia
Secondary sponsor category [3] 299326 0
Individual
Name [3] 299326 0
Dr. Yoshiro Okubo
Address [3] 299326 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [3] 299326 0
Australia
Secondary sponsor category [4] 299327 0
Individual
Name [4] 299327 0
Dr. Matthew Brodie
Address [4] 299327 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [4] 299327 0
Australia
Secondary sponsor category [5] 299328 0
Individual
Name [5] 299328 0
Prof Colleen Canning
Address [5] 299328 0
University of Sydney
C43O - O Block Cumberland Campus
Lidcombe NSW 1825
Country [5] 299328 0
Australia
Secondary sponsor category [6] 299329 0
Individual
Name [6] 299329 0
Mr Paulo Pelicioni
Address [6] 299329 0
Neuroscience Research Australia
Margarete Ainsworth Building
Barker Street
Randwick NSW 2031
Country [6] 299329 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300814 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 300814 0
UNSW Grants Management Office
Rupert Myers Building, Level 3, South Wing
University of New South Wales
NSW
2052
Ethics committee country [1] 300814 0
Australia
Date submitted for ethics approval [1] 300814 0
05/03/2018
Approval date [1] 300814 0
04/05/2018
Ethics approval number [1] 300814 0
HC180129

Summary
Brief summary
Our recent systematic review showed that both volitional and reactive step training reduce falls by approximately 50% in healthy older adults. Our recently completed randomized control trial (RCT) confirmed safety and effectiveness of home-based volitional step training in people with Parkinson’s disease (PD). We hypothesise that a combination of volitional and reactive step training will provide additional benefits, underpinned by differential motor control mechanisms of action. This is a single blind RCT using a parallel arm design including a 12-week intervention, pre- and post-intervention assessments and 6-month follow-up for falls. Our RCT will be the first to clarify the effectiveness of combined volitional and reactive step training on risk of falling in people with PD using state-of-art technology.
Trial website
Trial related presentations / publications
Public notes
Following assessments are not outcomes of this study but will be used during the baseline assessments to document participant characteristics.

Freezing of gait will be assessed using the New-Freezing of gait questionnaire (Nieuwboer et al., 2009).

Physical activity level will be assessed through the Incidental and Planned Activity Questionnaire for the elderly (Delbaere et al., Br J Sports Med, 2010)

Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), will be used to evaluate the clinical status of PD participants (Goetz et al., 2008).

Depressive and anxious mood will be assessed using the Hospital Anxiety and Depression Scale (Zigmond & Snaith, 1983).

Cognition will be assessed using the Montreal Cognitive Assessment (Nasreddine et al., 2005).

Proprioception will be measured using the lower-limb matching task (Lord et al., 2003: DeDominaco et al., 1987).

Vision will be assessed using the Melbourne Edge Test (Lord et al., 2003; Verbaken et al., 1986).

Muscle activation of the legs (i.e. rectus femoris, medial hamstrings, tibialis anterior and medial gastrocnemius) during the slip and trip trials will be assessed using surface EMG from only participants who agreed with the EMG recording.

Contacts
Principal investigator
Name 63194 0
Prof Stephen Lord
Address 63194 0
Neuroscience Research Australia
Barker St
Randwick
NSW
2031
Country 63194 0
Australia
Phone 63194 0
+61 2 9399 1061
Fax 63194 0
+61 2 9399 1120
Email 63194 0
[email protected]
Contact person for public queries
Name 63195 0
Stephen Lord
Address 63195 0
Neuroscience Research Australia
Barker St
Randwick
NSW
2031
Country 63195 0
Australia
Phone 63195 0
+61 2 9399 1061
Fax 63195 0
+61 2 9399 1120
Email 63195 0
[email protected]
Contact person for scientific queries
Name 63196 0
Stephen Lord
Address 63196 0
Neuroscience Research Australia
Barker St
Randwick
NSW
2031
Country 63196 0
Australia
Phone 63196 0
+61 2 9399 1061
Fax 63196 0
+61 2 9399 1120
Email 63196 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The ethics does not allow data sharing.


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.