NCT06571526

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 21, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2024

Completed
Last Updated

August 26, 2024

Status Verified

August 1, 2024

Enrollment Period

1.7 years

First QC Date

August 21, 2024

Last Update Submit

August 23, 2024

Conditions

Keywords

attentional focusgaitolder adultsvisual search

Outcome Measures

Primary Outcomes (2)

  • Gait stability

    Measured by a 3-D motion-capture system. Indicated by the variabilities of temporal and spatial gait parameters

    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

    pre-test, post-test (the same day, immediately after the single-session intervention), 1 week after post-test (retention)

Study Arms (2)

EXT

EXPERIMENTAL
Behavioral: External focus

CON

ACTIVE COMPARATOR
Behavioral: Control

Interventions

External focusBEHAVIORAL

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.

EXT
ControlBEHAVIORAL

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.

CON

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged 65 or above
  • were able to walk independently indoors without walking aids

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, 000, Hong Kong

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2024

First Posted

August 26, 2024

Study Start

October 1, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

August 26, 2024

Record last verified: 2024-08

Locations