Accidental FallsNCT04419753
The Role of Attention Focus Walking Training in Older Adults.
A study testing attention focus walking training in people with Accidental Falls and Rehabilitation, run by Dr. Thomson Wai-Lung Wong at 1 site in Hong Kong.
Trial summary
This study aims to examine the effect of external, internal and no attention focus walking training during gait rehabilitation on real-time conscious motor processing (reinvestment), balance, walking ability and fear of falling by older adults at risk of falling in Hong Kong. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Rehabilitation, Walking
- What is being tested?
- attention focus walking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2020to Sep 2022
- 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
- Age 65 or above;
- No history of cerebral vascular disease, Parkinson's disease or other neurological deficit;
- Chinese version of the Mini-Mental State Examination (MMSE-C) total score of equal or more than 24;
- Able to walk independently indoor for at least 40 meters continuously with comfortable pace;
- Older adults with moderate to high risk of falling, as indicated by the score of less than 24 out of 28 in the Tinetti Balance Assessment Tool.
Who cannot join
- Any potential participant who cannot meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Hong Kong Polytechnic University
Hung Hom
Thomson Wai Lung WONG, PhD, (852)27666717, thomson.wong@polyu.edu.hk
About this study
Official title: Examining the Role of External and Internal Attention Focus Walking Training on Conscious Motor Processing During Rehabilitation by Older Adults at Risk of Falling in Hong Kong: A Randomized Controlled Trial.
This study aims to examine the effect of external, internal and no attention focus walking training during gait rehabilitation on real-time conscious motor processing (reinvestment), balance, walking ability and fear of falling by older adults at risk of falling in Hong Kong.
One-hundred and eight older adults will be recruited from elderly community centers in Hong Kong. Participants will be randomly assigned into 3 groups (i.e., No Attention Focus Walking Group (NAFWG; active control group, n=36), an External Attention Focus Walking Group (EAFWG, n = 36) or an Internal Attention Focus Walking Group (IAFWG, n = 36)). Participants in different groups will have training sessions (about 45 minutes each) three times per week for 4 weeks in a group of 6 participants. A total of 12 sessions will be completed by each participant.
Read more
All training sessions will be conducted by experienced registered physiotherapists in Hong Kong and a research assistant with experience in exercise training for older adults. In each training session, all groups will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various levels of difficulties in a 40-meter walkway with different instructions in different walking groups (20 minutes) and cool down (5 minutes). For the walking training (20 minutes), all participants will be invited to conduct walking training on a walking field with an area of 25 meter square and a total walking distance of about 40 meters for each walking trial from cone 1 to 9. Two screens that connected with a laptop computer will be positioned 1 meter beside the walking field. Both screens will be projected different digits from 0 to 9 randomly in the speed of 2 seconds per digit. Participants in the NAFWG, EAFWG, and IAFWG will receive different instructions during walking training.
Each participant will complete assessment sessions (total 3 assessment sessions) before training at baseline (T0), just after completion of all training sessions (T1) and 6 months after completion of all training sessions (T2). In the baseline assessment (T0), a structural questionnaire will be used to ask for demographics, medical history, detailed history of fall incident, social history and social economic status of all participants. A battery of assessments will be conducted to assess physical and cognitive abilities of the participants in all assessment sessions (T0, T1, \& T2). Walking ability will be assessed by the 10 meters comfortable and fast walking speed (Bohannon, 1997). Functional balance and gait assessment will be done by the Tinetti Balance Assessment Tool (Tinetti, 1986), the Berg Balance Scale (BBS) (Berg et al., 1989) and the Timed 'Up \& Go' Tests (TU\&G) (Podsiadlo \& Richardson, 1991). Cognitive function will be evaluated by the Chinese version Mini-Mental State Examination (MMSE-C) (Folstein et al., 1975; Chiu et al., 1994). The Chinese version of the Fall Efficacy Scale International (FES-I (Ch)) (Kwan, Tsang, Close \& Lord, 2013) will be completed to assess the fear of falling. The Chinese version Movement Specific Reinvestment Scale (MSRS-C) (Masters et al., 2005; Wong et al., 2015a; Wong et al., 2015b) will be administered to examine the conscious motor processing propensity (i.e., movement specific reinvestment). The alpha2 EEG coherence between T3 (verbal-analytical region of the brain) and the Fz (motor planning region of the brain) (i.e., T3-Fz EEG coherence) of all participants when walking at the 6-meter level-ground walkway (three walking trials) will be determined to identify the real-time conscious motor processing propensity (Zhu et al., 2011; Ellmers et al., 2016; Chu \& Wong, 2019). All participants will be equipped with EEG electrodes before the start of the three walking trials. EEG activity will be received using a wireless EEG device (Brainquiry PET 4.0, Brainquiry, The Netherlands) and will be recorded using the real-time biophysical data acquisition software (BioExplorer 1.5, CyberEvolution, US). Previous research has demonstrated that alpha2 (10-12Hz) T3-Fz EEG coherence is sensitive at detecting within-subject changes in real-time conscious motor processing propensity during a postural sway task (Ellmers et al., 2016). T4-Fz EEG coherence will be utilized to identify whether the changes in the alpha2 T3-Fz EEG coherence will be due to global activation of the brain. The EEG electrodes are non-invasive and will not be used in any diagnostic purpose.
All participants will be asked to record their number of falls prospectively at the time between T1 (completion of all training sessions) and T2 (6 months after completion of all training sessions) using a structural calendar. The number of falls within the 6-month follow-up period will then be collected.
- Conditions
- Accidental Falls, Rehabilitation, Walking, Aged
- Being tested
- attention focus walking training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attention focus walking trainingBehavioural
Use different attention focus instructions or no attention focus instruction during walking training in older adults to examine whether the attention focus instructions can ameliorate conscious motor processing and optimize rehabilitation outcome measurements.
| Study group | Role | What they receive |
|---|---|---|
| No Attention Focus Walking Group (NAFWG) | Active comparator | In each training session, the NAFWG will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various levels of difficulties in a 40-meter walkway without attention focus instruction (20 minutes) and cool down (5 minutes). Receives: Behavioral: attention focus walking training |
| External Attention Focus Walking Group (EAFWG) | Experimental | In each training session, the EAFWG will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various levels of difficulties in a 40-meter walkway with external attention focus instructions (20 minutes) and cool down (5 minutes). Receives: Behavioral: attention focus walking training |
| Internal Attention Focus Walking Group (IAFWG) | Experimental | In each training session, the IAFWG will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various levels of difficulties in a 40-meter walkway with internal attention focus instructions (20 minutes) and cool down (5 minutes). Receives: Behavioral: attention focus walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Real-time conscious motor processing propensity at 1 month (post-training) and 7 months (6 months post-training)
will be measured by the Alpha 2 T3-Fz EEG coherence (Zhu et al., 2011; Ellmers et al., 2016; Chu \& Wong, 2019).
Measured: At Day 0, Month 1, and Month 7
Change from Baseline Functional balance and gait ability at 1 month (post-training) and 7 months (6 months post-training)
will be assessed by the Tinetti Balance Assessment Tool (Tinetti, 1986).
Measured: At Day 0, Month 1, and Month 7
Change from Baseline Functional balance ability at 1 month (post-training) and 7 months (6 months post-training)
will be assessed by the Berg Balance Scale (BBS) (Berg et al., 1989).
Measured: At Day 0, Month 1, and Month 7
Change from Baseline Functional gait ability at 1 month (post-training) and 7 months (6 months post-training)
will be assessed by the Timed 'Up \& Go' Tests (TU\&G) (Podsiadlo \& Richardson, 1991).
Measured: At Day 0, Month 1, and Month 7
Change from Baseline Walking ability at 1 month (post-training) and 7 months (6 months post-training)
will be assessed by the 10 meters comfortable and fast walking speed (Bohannon, 1997).
Measured: At Day 0, Month 1, and Month 7
Secondary outcomes (4)
Change from Baseline Conscious motor processing propensity (i.e., movement specific reinvestment) at 1 month (post-training) and 7 months (6 months post-training)
will be assessed by the Chinese version Movement Specific Reinvestment Scale (MSRS-C) (Masters et al., 2005; Wong et al., 2015a; Wong et al., 2015b).
Measured: At Day 0, Month 1, and Month 7
Change from Baseline Fear of falling at 1 month (post-training) and 7 months (6 months post-training)
will be assessed by the Chinese version of the Fall Efficacy Scale International (FES-I (Ch)) (Kwan, Tsang, Close \& Lord, 2013).
Measured: At Day 0, Month 1, and Month 7
Cognitive function
will be evaluated by the Cantonese version of the Mini-Mental State Examination (MMSE-C) (Chiu, Lee, Chung \& Kwong, 1994).
Measured: At Day 0
Change from Baseline Visuo-spatial involvement in movement control at 1 month (post-training) and 7 months (6 months post-training)
will be assessed by the Alpha 2 T4-Fz EEG coherence (Zhu et al., 2011; Ellmers et al., 2016; Chu \& Wong, 2019).
Measured: At Day 0, Month 1, and Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study startSep 2020 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Thomson Wai-Lung Wong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Sponsor-investigator, Dr. Thomson Wai-Lung Wong, The University of Hong Kong
- Investigators
- Thomson Wai Lung WONG, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419753
- Sponsor's protocol ID
- UW 19-099
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mak TCT, Ng SSM, Leung MCY, Wong TWL. Examining the role of attention focus walking training on conscious motor processing during rehabilitation by older adults at risk of falling: A randomized controlled trial. Arch Gerontol Geriatr. 2024 Jun;121:105352. doi: 10.1016/j.archger.2024.105352. Epub 2024 Jan 28.
PubMed 38340586
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Role of External and Internal Attention Focus Walking Training on Conscious Motor Processing During Rehabilitation by Older Adults at Risk of Falling in Hong Kong: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04419753
- Acronym / sponsor ID
- UW 19-099
- Conditions
- Accidental Falls, Rehabilitation, Walking, Aged
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Dr. Thomson Wai-Lung WongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- Sep 2020 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 5 Jun 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.
This study aims to examine the effect of external, internal and no attention focus walking training during gait rehabilitation on real-time conscious motor processing (reinvestment), balance, walking ability and fear of falling by older adults at risk of falling in Hong Kong.
One-hundred and eight older adults will be recruited from elderly community centers in Hong Kong. Participants will be randomly assigned into 3 groups (i.e., No Attention Focus Walking Group (NAFWG; active control group, n=36), an External Attention Focus Walking Group (EAFWG, n = 36) or an Internal Attention Focus Walking Group (IAFWG, n = 36)). Participants in different groups will have training sessions (about 45 minutes each) three times per week for 4 weeks in a group of 6 participants. A total of 12 sessions will be completed by each participant.
All training sessions will be conducted by experienced registered physiotherapists in Hong Kong and a research assistant with experience in exercise training for older adults. In each training session, all groups will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various levels of difficulties in a 40-meter walkway with different instructions in different walking groups (20 minutes) and cool down (5 minutes). For the walking training (20 minutes), all participants will be invited to conduct walking training on a walking field with an area of 25 meter square and a total walking distance of about 40 meters for each walking trial from cone 1 to 9. Two screens that connected with a laptop computer will be positioned 1 meter beside the walking field. Both screens will be projected different digits from 0 to 9 randomly in the speed of 2 seconds per digit. Participants in the NAFWG, EAFWG, and IAFWG will receive different instructions during walking training.
Each participant will complete assessment sessions (total 3 assessment sessions) before training at baseline (T0), just after completion of all training sessions (T1) and 6 months after completion of all training sessions (T2). In the baseline assessment (T0), a structural questionnaire will be used to ask for demographics, medical history, detailed history of fall incident, social history and social economic status of all participants. A battery of assessments will be conducted to assess physical and cognitive abilities of the participants in all assessment sessions (T0, T1, \& T2). Walking ability will be assessed by the 10 meters comfortable and fast walking speed (Bohannon, 1997). Functional balance and gait assessment will be done by the Tinetti Balance Assessment Tool (Tinetti, 1986), the Berg Balance Scale (BBS) (Berg et al., 1989) and the Timed 'Up \& Go' Tests (TU\&G) (Podsiadlo \& Richardson, 1991). Cognitive function will be evaluated by the Chinese version Mini-Mental State Examination (MMSE-C) (Folstein et al., 1975; Chiu et al., 1994). The Chinese version of the Fall Efficacy Scale International (FES-I (Ch)) (Kwan, Tsang, Close \& Lord, 2013) will be completed to assess the fear of falling. The Chinese version Movement Specific Reinvestment Scale (MSRS-C) (Masters et al., 2005; Wong et al., 2015a; Wong et al., 2015b) will be administered to examine the conscious motor processing propensity (i.e., movement specific reinvestment). The alpha2 EEG coherence between T3 (verbal-analytical region of the brain) and the Fz (motor planning region of the brain) (i.e., T3-Fz EEG coherence) of all participants when walking at the 6-meter level-ground walkway (three walking trials) will be determined to identify the real-time conscious motor processing propensity (Zhu et al., 2011; Ellmers et al., 2016; Chu \& Wong, 2019). All participants will be equipped with EEG electrodes before the start of the three walking trials. EEG activity will be received using a wireless EEG device (Brainquiry PET 4.0, Brainquiry, The Netherlands) and will be recorded using the real-time biophysical data acquisition software (BioExplorer 1.5, CyberEvolution, US). Previous research has demonstrated that alpha2 (10-12Hz) T3-Fz EEG coherence is sensitive at detecting within-subject changes in real-time conscious motor processing propensity during a postural sway task (Ellmers et al., 2016). T4-Fz EEG coherence will be utilized to identify whether the changes in the alpha2 T3-Fz EEG coherence will be due to global activation of the brain. The EEG electrodes are non-invasive and will not be used in any diagnostic purpose.
All participants will be asked to record their number of falls prospectively at the time between T1 (completion of all training sessions) and T2 (6 months after completion of all training sessions) using a structural calendar. The number of falls within the 6-month follow-up period will then be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Attention Focus Walking Group (NAFWG) | Active comparator | Behavioral: attention focus walking trainingIn each training session, the NAFWG will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various levels of difficulties in a 40-meter walkway without attention focus instruction (20 minutes) and cool down (5 minutes). |
| External Attention Focus Walking Group (EAFWG) | Experimental | Behavioral: attention focus walking trainingIn each training session, the EAFWG will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various levels of difficulties in a 40-meter walkway with external attention focus instructions (20 minutes) and cool down (5 minutes). |
| Internal Attention Focus Walking Group (IAFWG) | Experimental | Behavioral: attention focus walking trainingIn each training session, the IAFWG will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various levels of difficulties in a 40-meter walkway with internal attention focus instructions (20 minutes) and cool down (5 minutes). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age 65 or above;
- No history of cerebral vascular disease, Parkinson's disease or other neurological deficit;
- Chinese version of the Mini-Mental State Examination (MMSE-C) total score of equal or more than 24;
- Able to walk independently indoor for at least 40 meters continuously with comfortable pace;
- Older adults with moderate to high risk of falling, as indicated by the score of less than 24 out of 28 in the Tinetti Balance Assessment Tool.
Key exclusion criteria (1 listed)
- Any potential participant who cannot meet the inclusion criteria.
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 |
|---|---|---|
| attention focus walking trainingUse different attention focus instructions or no attention focus instruction during walking training in older adults to examine whether the attention focus instructions can ameliorate conscious motor processing and optimize rehabilitation outcome measurements. | Behavioural | External Attention Focus Walking Group (EAFWG), Internal Attention Focus Walking Group (IAFWG), No Attention Focus Walking Group (NAFWG) |
Primary outcome
Change from Baseline Real-time conscious motor processing propensity at 1 month (post-training) and 7 months (6 months post-training)
Time frame: At Day 0, Month 1, and Month 7
will be measured by the Alpha 2 T3-Fz EEG coherence (Zhu et al., 2011; Ellmers et al., 2016; Chu \& Wong, 2019).
Change from Baseline Functional balance and gait ability at 1 month (post-training) and 7 months (6 months post-training)
Time frame: At Day 0, Month 1, and Month 7
will be assessed by the Tinetti Balance Assessment Tool (Tinetti, 1986).
Change from Baseline Functional balance ability at 1 month (post-training) and 7 months (6 months post-training)
Time frame: At Day 0, Month 1, and Month 7
will be assessed by the Berg Balance Scale (BBS) (Berg et al., 1989).
Change from Baseline Functional gait ability at 1 month (post-training) and 7 months (6 months post-training)
Time frame: At Day 0, Month 1, and Month 7
will be assessed by the Timed 'Up \& Go' Tests (TU\&G) (Podsiadlo \& Richardson, 1991).
Change from Baseline Walking ability at 1 month (post-training) and 7 months (6 months post-training)
Time frame: At Day 0, Month 1, and Month 7
will be assessed by the 10 meters comfortable and fast walking speed (Bohannon, 1997).
4 secondary outcomes
Change from Baseline Conscious motor processing propensity (i.e., movement specific reinvestment) at 1 month (post-training) and 7 months (6 months post-training)
Time frame: At Day 0, Month 1, and Month 7
Change from Baseline Fear of falling at 1 month (post-training) and 7 months (6 months post-training)
Time frame: At Day 0, Month 1, and Month 7
Cognitive function
Time frame: At Day 0
Change from Baseline Visuo-spatial involvement in movement control at 1 month (post-training) and 7 months (6 months post-training)
Time frame: At Day 0, Month 1, and Month 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 38340586Mak TCT, Ng SSM, Leung MCY, Wong TWL. Examining the role of attention focus walking training on conscious motor processing during rehabilitation by older adults at risk of falling: A randomized controlled trial. Arch Gerontol Geriatr. 2024 Jun;121:105352. doi: 10.1016/j.archger.2024.105352. Epub 2024 Jan 28.
- Individual participant dataSharing planned: No
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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.
Thomson Wai Lung WONG, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing attention focus walking training in people with Accidental Falls and Rehabilitation, run by Dr. Thomson Wai-Lung Wong 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomson Wai Lung WONG, PhD ((852)27666717, thomson.wong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Real-time conscious motor processing propensity at 1 month (post-training) and 7 months (6 months post-training) (time frame: At Day 0, Month 1, and Month 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04419753, which also lists 1 linked publication.
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 11 Jun 2020.