FallNCT04602858
The SafeTrip Study - Step Training to Reduce Falls in Older Adults
A study testing Reactive Balance Training in people with Fall and Fall Injury, run by Neuroscience Research Australia at 1 site in Australia.
Trial summary
Falls in older people are devastating, widespread, costly and increasing in the aging Australian population. Although falls occur in approximately one third of older adults, certain population groups such as the sarcopenic/frail present with further elevated risk of falls. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Fall Injury
- What is being tested?
- Reactive Balance Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Dec 2020to 19 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Older persons - aged 65 years and older
- Community-dwelling
- Ability to walk 500m without rest or use of mobility aids
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Neuroscience Research Australia
Randwick, New South Wales, 2031
About this study
Official title: Reactive Balance Training Involving Repeated Trips and Slips in Older Adults: Mechanisms and Long-term Retention
Falls in older people are devastating, widespread, costly and increasing in the aging Australian population. Although falls occur in approximately one third of older adults, certain population groups such as the sarcopenic/frail present with further elevated risk of falls. Many exercise interventions have been trialled but systematic review evidence indicates such programs reduce fall rates by an average of only 20% and encounter issues such as compliance.
Reactive balance training (also called perturbation-based balance training) utilises a task-specific approach to balance training, applying repeated exposure to unpredictable perturbations that mimic balance disturbances experienced in daily life. Evidence suggests 50% reductions in falls might be achievable in a time efficient manner with reactive balance training but more evidence is required.
In this study, ecologically valid, unpredictable trips and slips will be exposed to older people in a safe environment to train their reactive balance. Three 40 min weekly training sessions will be followed by 3-monthly retraining session over one year (40 min x 6 training sessions = 4 hours of training in total). The neuromuscular, physiological, psychological, behavioural effects of the reactive balance training will be comprehensively examined.
- Conditions
- Fall, Fall Injury
- Being tested
- Reactive Balance Training, Control
- Keywords
- falls, fall prevention, balance, muscle, reflex, reactive balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reactive Balance TrainingDevice
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Reactive Balance Training | Experimental | 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. Receives: Device: Reactive Balance Training |
| Control | Active comparator | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory induced falls
Fall incidence after slips and trips in the laboratory (Okubo et al., 2019). A fall will be defined by the harness supported load when it exceeded 30% of the person's body weight (Yang et al., 2011).
Measured: 12 month re-assessment
Trips in daily life
Number of trips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
Measured: Throughout a follow-up period (one year from randomisation)
Slips in daily life
Number of slips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
Measured: Throughout a follow-up period (one year from randomisation)
Secondary outcomes (24)
Falls in daily life
Number of falls in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
Measured: Throughout a follow-up period (one year from randomisation)
Fall Risk
A summary fall risk score will be calculated from the Physiological Profile Assessment short form which includes tests of vision, balance, proprioception, reaction time and strength (Lord et al., 2003).
Measured: 12 month re-assessment
Fear of falling
Fear of falling will be assessed using the Falls Efficacy Scale - International (Yardley et al., 2005), a 16 item scale scored out of 64 where higher scores indicate greater fear of falling
Measured: Week 3 (following the third training session)
Fear of falling
Fear of falling will be assessed using the Falls Efficacy Scale - International (Yardley et al., 2005), a 16 item scale scored out of 64 where higher scores indicate greater fear of falling
Measured: Month 6 (middle of the follow-up period)
Fear of falling
Fear of falling will be assessed using the Falls Efficacy Scale - International (Yardley et al., 2005), a 16 item scale scored out of 64 where higher scores indicate greater fear of falling
Measured: 12 month re-assessment
Fall risk awareness and behaviours
Fall risk awareness and behaviours will be assessed using the 24-item Fall Behavioural Scale (Clemson et al., 2008). Mean scores range from 1.0 to 4.0 in which higher scores indicate safer behaviours
Measured: Week 3 (following the third training session)
Fall risk awareness and behaviours
Fall risk awareness and behaviours will be assessed using the 24-item Fall Behavioural Scale (Clemson et al., 2008). Mean scores range from 1.0 to 4.0 in which higher scores indicate safer behaviours
Measured: Month 6 (middle of the follow-up period)
Fall Behavioural Scale
Fall risk awareness and behaviours will be assessed using the 24-item Fall Behavioural Scale (Clemson et al., 2008). Mean scores range from 1.0 to 4.0 in which higher scores indicate safer behaviours
Measured: 12 month re-assessment
Anxiety
Anxiety will be assessed using the General Anxiety Disorder - 7-item scale (Spitzer, 2006), a 21 point scale where higher scores indicate greater anxiety
Measured: 12 month re-assessment
Physical activity levels
Physical activity levels will be assessed using the Incidental and Planned Exercise Questionnaire (Delbaere et al., 2009). A total physical activity (hours per week) in the past 3 months will be estimated.
Measured: 12 month re-assessment
Volitional Stepping Reaction time
Volitional stepping will be assessed using the Choice Stepping Reaction Time test standard version (Lord et al., 2001).
Measured: 12 month re-assessment
Stepping inhibition
Stepping inhibition will be assessed using the Choice Stepping Reaction Time test moving arrow version.
Measured: 12 month re-assessment
Catch-inhibition accuracy
Catch-inhibition accuracy will be assessed using the React Stick simple and complex modes (Richardson et al., 2017).
Measured: 12 month re-assessment
Executive function
Executive function will be assessed using the Trail Making Test A and B (Tombaugh et al., 2004). Test scores B - A will be used as a measure of executive function.
Measured: 12 month re-assessment
Margin of stability
Margin of stability (Hof et al., 2005) during the slip and trip trials will be assessed using the Vicon 3D motion analysis system with the full-body 27-marker model
Measured: 12 month re-assessment
Extrapolated centre of mass
Extrapolated centre of mass (Hof et al., 2005) during the slip and trip trials will be assessed using the Vicon 3D motion analysis system with the full-body 27-marker model
Measured: 12 month re-assessment
Step length
Step length during the slip and trip trials will be assessed using the Vicon 3D motion analysis system with the full-body 27-marker model
Measured: 12 month re-assessment
Range of trunk sway
Range of trunk sway during the slip and trip trials will be assessed using the Vicon 3D motion analysis system with the full-body 27-marker model
Measured: 12 month re-assessment
Muscle activation onset latency (semitendinosus)
Time (milliseconds) from a trip/slip onset to muscle activation onset will be recorded using surface electromyography on the semitendinosus. Muscle activation onset will be defined when the activation level exceeds 3 standard deviation above the baseline level.
Measured: 12 month re-assessment
Muscle activation onset latency (rectus femoris)
Time (milliseconds) from a trip/slip onset to muscle activation onset will be recorded using surface electromyography on the rectus femoris. Muscle activation onset will be defined when the activation level exceeds 3 standard deviation above the baseline level.
Measured: 12 month re-assessment
Muscle activation amplitude (semitendinosus)
Muscle activation amplitude will be recorded using surface electromyography on the semitendinosus. This will be assessed as percentage of the activation level during the trip and slip trials relative to the maximal voluntary contraction.
Measured: 12 month re-assessment
Muscle activation amplitude (rectus femoris)
Muscle activation amplitude will be recorded using surface electromyography on the rectus femoris. This will be assessed as percentage of the activation level during the trip and slip trials relative to the maximal voluntary contraction.
Measured: 12 month re-assessment
Enjoyment of reactive balance training
Enjoyment of reactive balance training will be assessed using the 8-item Physical Activity Enjoyment Scale (PACES-8, Mullen et al., 2011). Scores range from 8 to 56 with higher scores indicate greater enjoyment.
Measured: Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
Adverse events during reactive balance training
Adverse events such as muscle soreness, discomfort, pain or injury will be collected by staff during reactive balance training sessions.
Measured: Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Dec 2020
- Primary completion19 Nov 2023
- Study completion19 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuroscience Research Australia
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor
- Investigators
- Stephen Lord, PhD, Principal investigator, Neuroscience Research Australia (NeuRA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602858
- Sponsor's protocol ID
- HC190952
- Other IDs
- U1111-1258-0513
- Status last verified
- Mar 2024
- First submitted
- 14 Sep 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data containing assessment results collected during the trial
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactive Balance Training Involving Repeated Trips and Slips in Older Adults: Mechanisms and Long-term Retention
- ClinicalTrials.gov ID
- NCT04602858
- Acronym / sponsor ID
- HC190952
- Conditions
- Fall, Fall Injury
- Keywords
- falls, fall prevention, balance, muscle, reflex, reactive balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Neuroscience Research AustraliaUniversity, hospital or other
- Collaborators
- The University of New South Wales
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 19 Nov 2023 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Falls in older people are devastating, widespread, costly and increasing in the aging Australian population. Although falls occur in approximately one third of older adults, certain population groups such as the sarcopenic/frail present with further elevated risk of falls. Many exercise interventions have been trialled but systematic review evidence indicates such programs reduce fall rates by an average of only 20% and encounter issues such as compliance.
Reactive balance training (also called perturbation-based balance training) utilises a task-specific approach to balance training, applying repeated exposure to unpredictable perturbations that mimic balance disturbances experienced in daily life. Evidence suggests 50% reductions in falls might be achievable in a time efficient manner with reactive balance training but more evidence is required.
In this study, ecologically valid, unpredictable trips and slips will be exposed to older people in a safe environment to train their reactive balance. Three 40 min weekly training sessions will be followed by 3-monthly retraining session over one year (40 min x 6 training sessions = 4 hours of training in total). The neuromuscular, physiological, psychological, behavioural effects of the reactive balance training will be comprehensively examined.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reactive Balance Training | Experimental | Device: Reactive Balance TrainingParticipants 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. |
| Control | Active comparator | Other: ControlAfter 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Older persons - aged 65 years and older
- Community-dwelling
- Ability to walk 500m without rest or use of mobility aids
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reactive Balance TrainingReactive 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. | Device | Reactive Balance Training |
| ControlThe 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. | Other | Control |
Primary outcome
Laboratory induced falls
Time frame: 12 month re-assessment
Fall incidence after slips and trips in the laboratory (Okubo et al., 2019). A fall will be defined by the harness supported load when it exceeded 30% of the person's body weight (Yang et al., 2011).
Trips in daily life
Time frame: Throughout a follow-up period (one year from randomisation)
Number of trips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
Slips in daily life
Time frame: Throughout a follow-up period (one year from randomisation)
Number of slips in daily life will be recorded using a fridge calendar and reported weekly via SMS or email.
24 secondary outcomes
Falls in daily life
Time frame: Throughout a follow-up period (one year from randomisation)
Fall Risk
Time frame: 12 month re-assessment
Fear of falling
Time frame: Week 3 (following the third training session)
Fear of falling
Time frame: Month 6 (middle of the follow-up period)
Fear of falling
Time frame: 12 month re-assessment
Fall risk awareness and behaviours
Time frame: Week 3 (following the third training session)
Fall risk awareness and behaviours
Time frame: Month 6 (middle of the follow-up period)
Fall Behavioural Scale
Time frame: 12 month re-assessment
Anxiety
Time frame: 12 month re-assessment
Physical activity levels
Time frame: 12 month re-assessment
Volitional Stepping Reaction time
Time frame: 12 month re-assessment
Stepping inhibition
Time frame: 12 month re-assessment
Catch-inhibition accuracy
Time frame: 12 month re-assessment
Executive function
Time frame: 12 month re-assessment
Margin of stability
Time frame: 12 month re-assessment
Extrapolated centre of mass
Time frame: 12 month re-assessment
Step length
Time frame: 12 month re-assessment
Range of trunk sway
Time frame: 12 month re-assessment
Muscle activation onset latency (semitendinosus)
Time frame: 12 month re-assessment
Muscle activation onset latency (rectus femoris)
Time frame: 12 month re-assessment
Muscle activation amplitude (semitendinosus)
Time frame: 12 month re-assessment
Muscle activation amplitude (rectus femoris)
Time frame: 12 month re-assessment
Enjoyment of reactive balance training
Time frame: Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
Adverse events during reactive balance training
Time frame: Throughout training sessions taking place at week 1, 2 and 3, and month 3, 6 and 9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: Yes. De-identified participant data containing assessment results collected during the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Lord, PhD principal investigator
Neuroscience Research Australia (NeuRA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reactive Balance Training in people with Fall and Fall Injury, run by Neuroscience Research Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laboratory induced falls (time frame: 12 month re-assessment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.