GaitNCT06571526
External Focus Strategy on Visuomotor Control in Older Adults
A study testing External focus in people with Gait and Fall Risk, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Only a few studies have adopted external focus strategy as an intervention to mitigate the negative effects of heightened conscious movement processing in older adults. The goal was to investigate whether a single-session intervention (SSI) using external focus strategy could improve gait stability and visual search… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gait, Fall Risk, Older Adults
- What is being tested?
- External focus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2021to 30 Jun 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
- aged 65 or above
- were able to walk independently indoors without walking aids
Who cannot join
- a total score of less than 24 on the Chinese version of the Mini-Mental State Examination
- a static visual acuity poorer than 20/40 vision
- the presence of any untreated cerebral vascular disease, Parkinson\'s disease, or any other major neurological deficit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Visual Search Strategies and the Role of Attentional Focus During Psychomotor Gait Re-education in Older Adults at Risk of Falling: Implication for Fall Rehabilitation
Only a few studies have adopted external focus strategy as an intervention to mitigate the negative effects of heightened conscious movement processing in older adults. The goal was to investigate whether a single-session intervention (SSI) using external focus strategy could improve gait stability and visual search behaviors during adaptive locomotion among the older population.
Participants were randomly allocated to either an external focus (EXT) or a control group (CON). All participants performed an obstacle circumvention walking task along an 8-m walkway for five trials at pre-intervention (T0), post-intervention (T1), and retention (T2). The training phase included 20 walking trials. EXT focused on digits displayed on monitors at their path destinations, while CON walked naturally without any manipulation.
- Conditions
- Gait, Fall Risk, Older Adults
- Being tested
- External focus, Control
- Keywords
- attentional focus, gait, older adults, visual search
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External focusBehavioural
The training phase consisted of 20 consecutive training trials, with a rest interval of at least 30 seconds between trials. All participants had to circumvent an obstacle during each trial on the 8-m level-ground walkway. During each trial, the general instruction was to focus on a random series of digits ranging from 0 to 9 displayed on monitors placed at the immediate and future destinations of the walkway. Each number was displayed for at least 2 seconds to allow participants to have sufficient time to read them.
ControlBehavioural
The training phase consisted of 20 consecutive training trials, with a rest interval of at least 30 seconds between trials. All participants had to circumvent an obstacle during each trial on the 8-m level-ground walkway. During each trial, the general instruction was to walk to the end of the walkway at your natural pace.
| Study group | Role | What they receive |
|---|---|---|
| EXT | Experimental | Not described Receives: Behavioral: External focus |
| CON | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait stability
Measured by a 3-D motion-capture system. Indicated by the variabilities of temporal and spatial gait parameters
Measured: pre-test, post-test (the same day, immediately after the single-session intervention), 1 week after post-test (retention)
Visual search behavior
Measured by eye tracker.
Indicated by:
number of fixation (%) on ground number of fixation (%) on destination number of fixation (%) on obstacle number of fixation (%) on random areas fixation duration (%) on ground fixation duration (%) on destination fixation duration (%) on obstacle fixation duration (%) on random areas
Measured: pre-test, post-test (the same day, immediately after the single-session intervention), 1 week after post-test (retention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start1 Oct 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GaitStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571526
- Sponsor's protocol ID
- HSEARS20210525002
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Visual Search Strategies and the Role of Attentional Focus During Psychomotor Gait Re-education in Older Adults at Risk of Falling: Implication for Fall Rehabilitation
- ClinicalTrials.gov ID
- NCT06571526
- Acronym / sponsor ID
- HSEARS20210525002
- Conditions
- Gait, Fall Risk, Older Adults
- Keywords
- attentional focus, gait, older adults, visual search
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 26 Aug 2024 (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.
Only a few studies have adopted external focus strategy as an intervention to mitigate the negative effects of heightened conscious movement processing in older adults. The goal was to investigate whether a single-session intervention (SSI) using external focus strategy could improve gait stability and visual search behaviors during adaptive locomotion among the older population.
Participants were randomly allocated to either an external focus (EXT) or a control group (CON). All participants performed an obstacle circumvention walking task along an 8-m walkway for five trials at pre-intervention (T0), post-intervention (T1), and retention (T2). The training phase included 20 walking trials. EXT focused on digits displayed on monitors at their path destinations, while CON walked naturally without any manipulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXT | Experimental | Behavioral: External focus |
| CON | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- aged 65 or above
- were able to walk independently indoors without walking aids
Key exclusion criteria (3 listed)
- a total score of less than 24 on the Chinese version of the Mini-Mental State Examination
- a static visual acuity poorer than 20/40 vision
- the presence of any untreated cerebral vascular disease, Parkinson\'s disease, or any other major neurological deficit
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 |
|---|---|---|
| External focusThe training phase consisted of 20 consecutive training trials, with a rest interval of at least 30 seconds between trials. All participants had to circumvent an obstacle during each trial on the 8-m level-ground walkway. During each trial, the general instruction was to focus on a random series of digits ranging from 0 to 9 displayed on monitors placed at the immediate and future destinations of the walkway. Each number was displayed for at least 2 seconds to allow participants to have sufficient time to read them. | Behavioural | EXT |
| ControlThe training phase consisted of 20 consecutive training trials, with a rest interval of at least 30 seconds between trials. All participants had to circumvent an obstacle during each trial on the 8-m level-ground walkway. During each trial, the general instruction was to walk to the end of the walkway at your natural pace. | Behavioural | CON |
Primary outcome
Gait stability
Time frame: pre-test, post-test (the same day, immediately after the single-session intervention), 1 week after post-test (retention)
Measured by a 3-D motion-capture system. Indicated by the variabilities of temporal and spatial gait parameters
Visual search behavior
Time frame: pre-test, post-test (the same day, immediately after the single-session intervention), 1 week after post-test (retention)
Measured by eye tracker. Indicated by: number of fixation (%) on ground number of fixation (%) on destination number of fixation (%) on obstacle number of fixation (%) on random areas fixation duration (%) on ground fixation duration (%) on destination fixation duration (%) on obstacle fixation duration (%) on random areas
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 26 Aug 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External focus in people with Gait and Fall Risk, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 2 inclusion and 3 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 26 Aug 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 Hong Kong. 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?
Gait stability (time frame: pre-test, post-test (the same day, immediately after the single-session intervention), 1 week after post-test (retention)). The study lists 2 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 26 Aug 2024.