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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04602858




Registration number
NCT04602858
Ethics application status
Date submitted
14/09/2020
Date registered
26/10/2020

Titles & IDs
Public title
The SafeTrip Study - Step Training to Reduce Falls in Older Adults
Scientific title
Reactive Balance Training Involving Repeated Trips and Slips in Older Adults: Mechanisms and Long-term Retention
Secondary ID [1] 0 0
U1111-1258-0513
Secondary ID [2] 0 0
HC190952
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fall 0 0
Fall Injury 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Reactive Balance Training
Other interventions - Control

Experimental: Reactive Balance Training - Participants randomised to the intervention group will initially undertake 3 x 40 min training sessions of reactive balance training over 3 weeks followed by 3-monthly retraining sessions at 3, 6 and 9 months, and final assessment at month 12.

During the training, participants will be exposed to unpredictable slips and trips whilst they are walking on the Trip and Slip Walkway (Okubo et al. 2019). They will be required to consistently walk at their normal walking pace using our gait regulation protocol (i.e. individually adjusted stepping tiles and metronome). Each training session will involve up to 30 trips and slips which progress in unpredictability.

Participants will also receive a "Staying active and on your feet" fall prevention booklet containing guidance regarding fall risk factors including exercise, diet, vision, footwear, medications and home safety.

Active comparator: Control - After exposing the control group to one trip and one slip at baseline, participants will then be provided with the "Staying active and on your feet" fall prevention booklet, an educational booklet providing guidance on fall risk factors including exercise, diet, vision, footwear, medications and home safety. The control group will then return for a reassessment after 12 months.


Treatment: Devices: Reactive Balance Training
Reactive balance training involves the use of the Trip and Slip walkway that is able to expose participants to unpredictable trips and slips. Trips and slips will occur at random location on the walkway and times within the gait cycle, with the participants receiving 3-monthly retraining sessions along with an educational booklet.

Other interventions: Control
The control intervention will be receiving an educational booklet as part of standard care. The education component will target a variety of fall risk factors and provide strategies to mitigate these risk factors.
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Laboratory induced falls
Timepoint [1] 0 0
12 month re-assessment
Primary outcome [2] 0 0
Trips in daily life
Timepoint [2] 0 0
Throughout a follow-up period (one year from randomisation)
Primary outcome [3] 0 0
Slips in daily life
Timepoint [3] 0 0
Throughout a follow-up period (one year from randomisation)
Secondary outcome [1] 0 0
Falls in daily life
Timepoint [1] 0 0
Throughout a follow-up period (one year from randomisation)
Secondary outcome [2] 0 0
Fall Risk
Timepoint [2] 0 0
12 month re-assessment
Secondary outcome [3] 0 0
Fear of falling
Timepoint [3] 0 0
Week 3 (following the third training session)
Secondary outcome [4] 0 0
Fear of falling
Timepoint [4] 0 0
Month 6 (middle of the follow-up period)
Secondary outcome [5] 0 0
Fear of falling
Timepoint [5] 0 0
12 month re-assessment
Secondary outcome [6] 0 0
Fall risk awareness and behaviours
Timepoint [6] 0 0
Week 3 (following the third training session)
Secondary outcome [7] 0 0
Fall risk awareness and behaviours
Timepoint [7] 0 0
Month 6 (middle of the follow-up period)
Secondary outcome [8] 0 0
Fall Behavioural Scale
Timepoint [8] 0 0
12 month re-assessment
Secondary outcome [9] 0 0
Anxiety
Timepoint [9] 0 0
12 month re-assessment
Secondary outcome [10] 0 0
Physical activity levels
Timepoint [10] 0 0
12 month re-assessment
Secondary outcome [11] 0 0
Volitional Stepping Reaction time
Timepoint [11] 0 0
12 month re-assessment
Secondary outcome [12] 0 0
Stepping inhibition
Timepoint [12] 0 0
12 month re-assessment
Secondary outcome [13] 0 0
Catch-inhibition accuracy
Timepoint [13] 0 0
12 month re-assessment
Secondary outcome [14] 0 0
Executive function
Timepoint [14] 0 0
12 month re-assessment
Secondary outcome [15] 0 0
Margin of stability
Timepoint [15] 0 0
12 month re-assessment
Secondary outcome [16] 0 0
Extrapolated centre of mass
Timepoint [16] 0 0
12 month re-assessment
Secondary outcome [17] 0 0
Step length
Timepoint [17] 0 0
12 month re-assessment
Secondary outcome [18] 0 0
Range of trunk sway
Timepoint [18] 0 0
12 month re-assessment
Secondary outcome [19] 0 0
Muscle activation onset latency (semitendinosus)
Timepoint [19] 0 0
12 month re-assessment
Secondary outcome [20] 0 0
Muscle activation onset latency (rectus femoris)
Timepoint [20] 0 0
12 month re-assessment
Secondary outcome [21] 0 0
Muscle activation amplitude (semitendinosus)
Timepoint [21] 0 0
12 month re-assessment
Secondary outcome [22] 0 0
Muscle activation amplitude (rectus femoris)
Timepoint [22] 0 0
12 month re-assessment
Secondary outcome [23] 0 0
Enjoyment of reactive balance training
Timepoint [23] 0 0
Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
Secondary outcome [24] 0 0
Adverse events during reactive balance training
Timepoint [24] 0 0
Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9

Eligibility
Key inclusion criteria
* Older persons - aged 65 years and older
* Community-dwelling
* Ability to walk 500m without rest or use of mobility aids
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Diagnosed neurological disease - eg Parkinson's disease, multiple sclerosis
* Cognitive impairment and dementia
* Bone fractures or joint replacement (in the past year)
* Pre-existing medical conditions from which the medical practitioner has advised not to exercise

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/11/2023
Sample size
Target
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Neuroscience Research Australia - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The University of New South Wales
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Stephen Lord, PhD
Address 0 0
Neuroscience Research Australia (NeuRA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified participant data containing assessment results collected during the trial
When will data be available (start and end dates)?
Following publication of main study findings
Available to whom?
Request should be made to the principal investigator and UNSW Human Research Ethics Committee which will be reviewed on a case-by-case basis
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04602858