NCT05630911

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

November 18, 2022

Last Update Submit

February 27, 2024

Conditions

Keywords

Older Adults in Hong KongConscious Movement ProcessingPostural StabilityMuscle EfficiencyAttentional Focus

Outcome Measures

Primary Outcomes (1)

  • Real-time (state) conscious movement processing propensity

    It will be measured by the Alpha2 electrocephalogram (EEG) T3-Fz coherence.

    Day 0

Secondary Outcomes (7)

  • Postural stability

    Day 0

  • Muscle efficiency

    Day 0

  • Functional mobility

    Day 0

  • Balance ability

    Day 0

  • Fear of falling

    Day 0

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Other: Standing tasks with different task difficulty

Interventions

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.

High Reinvestor Group (HRG)Low Reinvestor Group (LRG)

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • years old or above;
  • able to stand independently without a walking aid.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Thomson Wong, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2022

First Posted

November 30, 2022

Study Start

January 1, 2023

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations