Fall InjuryNCT05630911
Conscious Movement Processing, Postural Stability and Muscle Efficiency in Older Adults
An observational study of Fall Injury and Postural; Defect, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
This study aims to address critical knowledge gaps by investigating the effects of trait conscious movement processing propensity on real-time (state) conscious movement processing propensity, postural stability, and muscle efficiency in older adults at risk of falling in Hong Kong with high and low trait conscious… Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall Injury, Postural; Defect, Old Age; Debility
- What is being tested?
- Standing tasks with different task difficulty
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 30 Jun 2025
- Phase
- Observational
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The recruitment of older adult participants (N = 132) will take place at collaborating rehabilitative and elderly community centres in Hong Kong through convenience sampling. Potential participants will be screened for eligibility according to the inclusion and exclusion criteria.
Who may be able to join
- 65 years old or above;
- able to stand independently without a walking aid.
Who cannot join
- a history of any major cerebrovascular and/or neurological disorders (e.g., stroke, Parkinson's disease);
- a history of a major fall event within the past year;
- the existence of an unstable medical or mobility condition that could affect safety in this study;
- a score of 23/30 or below in the Chinese version of Mini-Mental State Examination (MMSE-C);
- a static visual acuity poorer than 20/40 vision (examined by the Tumbling-E eye chart).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Thomson Wong, PhD, (852)27666717, thomson.wong@polyu.edu.hk
About this study
Official title: The Effects of Conscious Movement Processing on Postural Stability and Muscle Efficiency While Standing in a Challenging Environment by Older Adults at Risk of Falling in Hong Kong: Implications for Rehabilitation.
This study aims to address critical knowledge gaps by investigating the effects of trait conscious movement processing propensity on real-time (state) conscious movement processing propensity, postural stability, and muscle efficiency in older adults at risk of falling in Hong Kong with high and low trait conscious movement processing propensities, while standing in a challenging environment with different levels of standing task difficulties. The study results would contribute to our scientific understanding of the mechanisms of conscious movement processing in older adults while maintaining standing balance in a challenging environment. It could inform the follow-up investigations for the development of the most appropriate psychomotor standing balance re-education intervention in rehabilitation so as to mitigate the effect of conscious movement processing and the risk of falling in older adults. The findings from the proposed research could ultimately help improve the outcome of fall rehabilitation programmes and reduce the impact of falls in the older adults in Hong Kong.
- Conditions
- Fall Injury, Postural; Defect, Old Age; Debility
- Being tested
- Standing tasks with different task difficulty
- Keywords
- Older Adults in Hong Kong, Conscious Movement Processing, Postural Stability, Muscle Efficiency, Attentional Focus
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standing tasks with different task difficultyOther
The three different standing positions will include wide-base standing on foam (WBF) with low-level of task difficulty, narrow-base standing on foam (NBF) with moderate-level of task difficulty, and tandem standing on foam (TAF) with high-level of task difficulty.
| Study group | Role | What they receive |
|---|---|---|
| High Reinvestor Group (HRG) | Participants will be invited to complete a series of standing balance trials. The trials will involve participants standing in three different positions on a foam surface (i.e., Airex balance pad elite with a dimension of 16.1" width x 19.7" length x 2.4" height, or equivalent).The three different standing positions will be: wide-base standing on foam (WBF), narrow-base standing on foam (NBF), and tandem standing on foam (TAF) (i.e., low-level of task difficulty, moderate-level of task difficulty, and high-level of task difficulty, respectively). For each standing position, participants will be required to perform two consecutive standing balance trials, with a 1-minute rest break in between. Receives: Other: Standing tasks with different task difficulty | |
| Low Reinvestor Group (LRG) | Participants will be invited to complete a series of standing balance trials. The trials will involve participants standing in three different positions on a foam surface (i.e., Airex balance pad elite with a dimension of 16.1" width x 19.7" length x 2.4" height, or equivalent).The three different standing positions will be: wide-base standing on foam (WBF), narrow-base standing on foam (NBF), and tandem standing on foam (TAF) (i.e., low-level of task difficulty, moderate-level of task difficulty, and high-level of task difficulty, respectively). For each standing position, participants will be required to perform two consecutive standing balance trials, with a 1-minute rest break in between. Receives: Other: Standing tasks with different task difficulty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time (state) conscious movement processing propensity
It will be measured by the Alpha2 electrocephalogram (EEG) T3-Fz coherence.
Measured: Day 0
Secondary outcomes (7)
Postural stability
It will be measured by the 3-D motion capture system to identify the postural sway in the unit of millimeter (mm) or the postural sway velocity in the unit of meter per second (m/s).
Measured: Day 0
Muscle efficiency
It will be measured by the surface electromyography (EMG).
Measured: Day 0
Functional mobility
It will be measured by the Timed 'Up \& Go' (TUG) test.
Measured: Day 0
Balance ability
It will be measured by the Berg Balance Scale. The minimum value of the scale is 0 and the maximum value is 56. Higher score represents better balance ability.
Measured: Day 0
Fear of falling
It will be measured by the Falls Efficacy Scale International. The minimum value of the scale is 16 and the maximum value is 64. Higher score represents higher fear of falling.
Measured: Day 0
Trait conscious movement processing propensity
It will be measured by the the Chinese version of the Movement-Specific Reinvestment Scale. The minimum value of the scale is 10 and the maximum value is 60. Higher score represents higher trait conscious movement processing propensity.
Measured: Day 0
Perceived standing task difficulty
It will be measured by the Visual Analog Scale. The minimum value of the scale is 0 and the maximum value is 100. Higher score represents higher perceived standing task difficulty.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Jan 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fall InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomson Wong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630911
- Sponsor's protocol ID
- 15600322
- Status last verified
- Feb 2024
- First submitted
- 18 Nov 2022
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Conscious Movement Processing on Postural Stability and Muscle Efficiency While Standing in a Challenging Environment by Older Adults at Risk of Falling in Hong Kong: Implications for Rehabilitation.
- ClinicalTrials.gov ID
- NCT05630911
- Acronym / sponsor ID
- 15600322
- Conditions
- Fall Injury, Postural; Defect, Old Age; Debility
- Keywords
- Older Adults in Hong Kong, Conscious Movement Processing, Postural Stability, Muscle Efficiency, Attentional Focus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 30 Nov 2022 (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 address critical knowledge gaps by investigating the effects of trait conscious movement processing propensity on real-time (state) conscious movement processing propensity, postural stability, and muscle efficiency in older adults at risk of falling in Hong Kong with high and low trait conscious movement processing propensities, while standing in a challenging environment with different levels of standing task difficulties. The study results would contribute to our scientific understanding of the mechanisms of conscious movement processing in older adults while maintaining standing balance in a challenging environment. It could inform the follow-up investigations for the development of the most appropriate psychomotor standing balance re-education intervention in rehabilitation so as to mitigate the effect of conscious movement processing and the risk of falling in older adults. The findings from the proposed research could ultimately help improve the outcome of fall rehabilitation programmes and reduce the impact of falls in the older adults in Hong Kong.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Reinvestor Group (HRG) | – | Other: Standing tasks with different task difficultyParticipants will be invited to complete a series of standing balance trials. The trials will involve participants standing in three different positions on a foam surface (i.e., Airex balance pad elite with a dimension of 16.1" width x 19.7" length x 2.4" height, or equivalent).The three different standing positions will be: wide-base standing on foam (WBF), narrow-base standing on foam (NBF), and tandem standing on foam (TAF) (i.e., low-level of task difficulty, moderate-level of task difficulty, and high-level of task difficulty, respectively). For each standing position, participants will be required to perform two consecutive standing balance trials, with a 1-minute rest break in between. |
| Low Reinvestor Group (LRG) | – | Other: Standing tasks with different task difficultyParticipants will be invited to complete a series of standing balance trials. The trials will involve participants standing in three different positions on a foam surface (i.e., Airex balance pad elite with a dimension of 16.1" width x 19.7" length x 2.4" height, or equivalent).The three different standing positions will be: wide-base standing on foam (WBF), narrow-base standing on foam (NBF), and tandem standing on foam (TAF) (i.e., low-level of task difficulty, moderate-level of task difficulty, and high-level of task difficulty, respectively). For each standing position, participants will be required to perform two consecutive standing balance trials, with a 1-minute rest break in between. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The recruitment of older adult participants (N = 132) will take place at collaborating rehabilitative and elderly community centres in Hong Kong through convenience sampling. Potential participants will be screened for eligibility according to the inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- 65 years old or above;
- able to stand independently without a walking aid.
Key exclusion criteria (5 listed)
- a history of any major cerebrovascular and/or neurological disorders (e.g., stroke, Parkinson's disease);
- a history of a major fall event within the past year;
- the existence of an unstable medical or mobility condition that could affect safety in this study;
- a score of 23/30 or below in the Chinese version of Mini-Mental State Examination (MMSE-C);
- a static visual acuity poorer than 20/40 vision (examined by the Tumbling-E eye chart).
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 |
|---|---|---|
| Standing tasks with different task difficultyThe three different standing positions will include wide-base standing on foam (WBF) with low-level of task difficulty, narrow-base standing on foam (NBF) with moderate-level of task difficulty, and tandem standing on foam (TAF) with high-level of task difficulty. | Other | High Reinvestor Group (HRG), Low Reinvestor Group (LRG) |
Primary outcome
Real-time (state) conscious movement processing propensity
Time frame: Day 0
It will be measured by the Alpha2 electrocephalogram (EEG) T3-Fz coherence.
7 secondary outcomes
Postural stability
Time frame: Day 0
Muscle efficiency
Time frame: Day 0
Functional mobility
Time frame: Day 0
Balance ability
Time frame: Day 0
Fear of falling
Time frame: Day 0
Trait conscious movement processing propensity
Time frame: Day 0
Perceived standing task difficulty
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Fall Injury
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Fall Risk Assessment and Speech Intelligibility Enhancement Using In-ear Device
Hearing Loss, Dizziness
Active, not recruiting
COMPARATIVE EFFECTS OF SENSORY REWEIGHTING AND PROPRIOCEPTIVE FACILITATION TRAINING ON BALANCE AND FALL RISK IN DIABETIC PERIPHERAL NEUROPATHY
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Exercise and Fall Prevention
Osteopenia, Osteoporosis
Not yet recruiting
Beren Vibration Insole in Stroke Rehabilitation
Stroke
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 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?
An observational study of Fall Injury and Postural; Defect, run by The Hong Kong Polytechnic University at 1 site in China.
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 5 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 29 Feb 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 China. 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 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?
Real-time (state) conscious movement processing propensity (time frame: Day 0). 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 29 Feb 2024.