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Trial registered on ANZCTR


Registration number
ACTRN12617000564358
Ethics application status
Approved
Date submitted
5/04/2017
Date registered
21/04/2017
Date last updated
11/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Slip and trip training for falls prevention in older adults
Scientific title
Reactive step training to improve reactive responses to slips and trips in older adults: a randomized controlled trial
Secondary ID [1] 291535 0
The Slip-Trip study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reactive stepping performance to avoid falls 302628 0
Condition category
Condition code
Injuries and Accidents 302149 302149 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 302159 302159 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (reactive step training) group will walk along a 10-m walkway consisting of 50cm x 50cm wooden decking tiles. They will be asked to step onto step-length black and white vinyl target tiles placed on the walkway with the accompaniment of music with a beat reflecting the desired cadence. Slips will be induced by a movable tile on two hidden low-friction rails with linear bearings that can slide upon foot contact (20cm, 30cm or 40cm). A friction plat will be applied to slow down the slip speed until a participant learns to respond well. Trips are induced using a tripping board (7cm or 14cm height) that flips up from the walkway at mid-swing using a wireless controller. The tripping board and the slipping tile are concealed and can be moved to various locations along the walkway so that proactive adaptation (e.g. changing gait with prediction) will be minimized and reactive stepping response can be specifically trained. Gait speed (40% to 90% of individual's normal gait), slip distance (20cm, 30cm or 40cm) and speed (with/without the friction plate) will be adjusted by a Health Fitness Programmer according to participant's anxiety level and perceived difficulty. Reactive step training will be conducted in three 40-minute sessions (120 minutes in total). Session 1 will train recovery from trips, session 2 will train recovery from slips and session 3 will train recovery from a mix of trips and slips. The 3 individual sessions will be held in 2 days (1st day: training sessions 1 and 2 with lunch break, 2nd day: training session 3) within a week. Attendance of and actual training contents (e.g. gait speed, slip distance and trip height) used for each participant will be recorded.
Intervention code [1] 297605 0
Treatment: Other
Intervention code [2] 297606 0
Prevention
Comparator / control treatment
The control (target step walking) group will walk on the same walkway. They will be asked to step on the target tiles, with the accompaniment of music with a beat reflecting the desired cadence but without slip and trip perturbations for 30 times (equivalent to the number of walks in a session for the intervention group) in one 40-minute session.
Control group
Active

Outcomes
Primary outcome [1] 301586 0
Fall incidence after slip- and trip-perturbations in the laboratory. All participants will be asked to walk at 90% of their normal gait speed. The gait speed will be constrained using the black and white vinyl stepping tiles (adjusted to 95% of normal step length) and metronome (adjusted to 95% of normal cadence). Non-friction 70cm slip and 14cm trip at random locations will be used.
Timepoint [1] 301586 0
Immediately after the intervention
Primary outcome [2] 301662 0
Margin of stability after slip- and trip-perturbations. An 8-camera Vicon motion analysis system will be used to record kinematic data during slip and trip trials. The margin of stability in anterior-posterior direction will be calculated as the distance between an extrapolated centre of mass to a closest base of support limit.
Timepoint [2] 301662 0
Immediately after the intervention
Secondary outcome [1] 333192 0
Kinematic characteristics of the balance response (step length/height, slipping distance/speed, extrapolated centre of mass displacement, foot contact angle, etc) immidediately before and after slip- and trip-onsets. An 8-camera Vicon motion analysis system will be used to record kinematic data during slip and trip trials.
Timepoint [1] 333192 0
Immediately after the intervention
Secondary outcome [2] 333193 0
Physiological profile assessment-short form
Timepoint [2] 333193 0
Baseline and immediately after the intervention
Secondary outcome [3] 333194 0
Choice stepping reaction time (CSRT) with inhibitory stimulus. The CSRT system consists of an electronic step mat, integrated with a computer via Bluetooth. The computer unit and monitor will be placed on the ground 50 cm in front of the step mat. Participants will be asked to view the screen that displays the stepping arrows and step onto the corresponding step mat target panel as quickly as possible.
Timepoint [3] 333194 0
Baseline and immediately after the intervention
Secondary outcome [4] 333474 0
Foot reaction time. This will be assessed using a hand-held electronic timer and a light as the stimulus and depression of a switch by the foot.
Timepoint [4] 333474 0
Baseline and immediately after the intervention

Eligibility
Key inclusion criteria
Older adults living independently in the community or retirement village.
Exercising for 90 minutes per week (e.g. fitness class, walking specifically for exercise, strength training, Tai Chi, etc) for the past 3 months.
Minimum age
65 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Osteoporosis, neurological impairment and a history of fractures in the last 3 years, or joint replacement in the past 12 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)
A research assistant, who is not a co-author, will perform the simple randomization using a random number created with Excel 2010 in a locked electronic file. A tester will contact this research assistant after baseline assessment to determine participants’ group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomization table will be created with Excel 2010.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Forty participants will be recruited. This sample size will be sufficient to detect a difference in the proportion of fallers in the intervention and control groups in the laboratory based on the following assumptions: (10% fallers in intervention group, 50% fallers in control group, alpha error: 0.05, power: 0,80 and allocation ratio: 1:1).

Chi-squared test will be used to examine the between-group difference in falls after the slip- and trip-perturbations. The analysis of variance (ANOVA) will be used to examine the time (pre/post) and group (intervention/control) interactions in the continuous outcomes. Paired t-test will be used to examine the within-group (pre-post) changes in the continuous outcomes.

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)
NSW
Recruitment hospital [1] 7733 0
Neuroscience Research Australia (NeuRA) - Randwick
Recruitment postcode(s) [1] 15658 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 296027 0
Government body
Name [1] 296027 0
National Health and Medical Research Council
Address [1] 296027 0
Level 1, Fawkner Centre, 499 St Kilda Road, Melbourne Vic 3004
Country [1] 296027 0
Australia
Funding source category [2] 296039 0
Government body
Name [2] 296039 0
Japan Society for the Promotion of Science
Address [2] 296039 0
5-3-1 Kojimachi, Chiyoda-ku, Tokyo 102-0083
Country [2] 296039 0
Japan
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Margarete Ainsworth Building
Barker Street Randwick Sydney NSW 2031
Country
Australia
Secondary sponsor category [1] 294931 0
None
Name [1] 294931 0
Address [1] 294931 0
Country [1] 294931 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297286 0
Human Research Ethics Committee of the University of New South Wales
Ethics committee address [1] 297286 0
Sydney NSW 2052
Ethics committee country [1] 297286 0
Australia
Date submitted for ethics approval [1] 297286 0
29/03/2016
Approval date [1] 297286 0
21/04/2016
Ethics approval number [1] 297286 0
HC16227

Summary
Brief summary
Falls among older adults cause serious challenges for the individual and health care systems, including bone fractures. Our recent systematic review and meta-analysis has shown that reactive step training (repeated exposure to balance perturbations) can reduce falls by approximately 50% (Okubo et al., 2016). However, the methods to generate perturbations (e.g. slips) in previous studies have been considerably heterogeneous and have limitations to training reactive balance control. We have developed a novel overground perturbation system which can generate both slips and trips in random locations. Since this system can provide unpredictable slips and trips, it is theoretically possible to train specifically reactive balance control (as opposed to proactive balance control or prediction). This randomized controlled trial will examine the effectiveness of the reactive step training using this perturbation system in older adults.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73582 0
Prof Stephen R Lord
Address 73582 0
Neuroscience Research Australia, Barker Street Randwick, Randwick, NSW 2031
Country 73582 0
Australia
Phone 73582 0
+61 2 9399 1061
Fax 73582 0
Email 73582 0
s.lord@neura.edu.au
Contact person for public queries
Name 73583 0
Dr Yoshiro Okubo
Address 73583 0
Neuroscience Research Australia, Barker Street Randwick, Randwick, NSW 2031
Country 73583 0
Australia
Phone 73583 0
+61 2 9399 1065
Fax 73583 0
Email 73583 0
y.okubo@neura.edu.au
Contact person for scientific queries
Name 73584 0
Dr Yoshiro Okubo
Address 73584 0
Neuroscience Research Australia, Barker Street Randwick, Randwick, NSW 2031
Country 73584 0
Australia
Phone 73584 0
+61 2 9399 1065
Fax 73584 0
Email 73584 0
y.okubo@neura.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary