NCT07085364

Brief Summary

This study will be a pilot randomized controlled trial, to investigate the effectiveness of an external focus training on visuomotor performance while comparing with an active control group.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Aug 2025May 2026

First Submitted

Initial submission to the registry

June 5, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

July 25, 2025

Status Verified

June 1, 2025

Enrollment Period

6 months

First QC Date

June 5, 2025

Last Update Submit

July 17, 2025

Conditions

Keywords

attentional focusgaitvisual searcholder adults

Outcome Measures

Primary Outcomes (6)

  • Gait stability - variability of stride time

    measured by a 3-D motion capture system; stride time is defined as the interval between two consecutive heel strikes of the same foot; the variability measure is represented by the coefficients of variation (CV) \[(standard deviation/mean) × 100\]

    baseline (pre-intervention), immediately after intervention (post-intervention)

  • Gait stability - variability of stride length

    measured by a 3-D motion capture system; stride length is defined as anterior-posterior (A-P) distance between two consecutive heel strike positions of the same foot; the variability measure is represented by the coefficients of variation (CV) \[(standard deviation/mean) × 100\]

    baseline (pre-intervention), immediately after intervention (post-intervention)

  • Gait stability - variability of step width

    measured by a 3-D motion capture system; step width is defined as medial-lateral (M-L) distance between two consecutive heel strike positions of the opposite feet; the variability measure is represented by the coefficients of variation (CV) \[(standard deviation/mean) × 100\]

    baseline (pre-intervention), immediately after intervention (post-intervention)

  • Visual search behaviours - location of fixation

    measured by a wireless eye tracker; recorded the location that the gaze is fixated on

    baseline (pre-intervention), immediately after intervention (post-intervention)

  • Visual search behaviours - the number of fixation

    measured by a wireless eye tracker; recorded the number of times the gaze is fixated on each area of interest

    baseline (pre-intervention), immediately after intervention (post-intervention)

  • Visual search behaviours - fixation duration

    measured by a wireless eye tracker; recorded the duration that the gaze is fixated on each area of interest

    baseline (pre-intervention), immediately after intervention (post-intervention)

Secondary Outcomes (5)

  • Functional balance and gait

    baseline (pre-intervention), immediately after intervention (post-intervention)

  • Falls efficacy

    baseline (pre-intervention), immediately after intervention (post-intervention)

  • Conscious movement processing

    baseline (pre-intervention), immediately after intervention (post-intervention)

  • Functional balance

    baseline (pre-intervention), immediately after intervention (post-intervention)

  • Functional mobility

    baseline (pre-intervention), immediately after intervention (post-intervention)

Study Arms (2)

EXT

EXPERIMENTAL

External focus manipulation

Behavioral: Attentional focus

CON

ACTIVE COMPARATOR

Traditional manipulation

Behavioral: Control

Interventions

Every training session will include the following activities for both groups: a 5-minute warm-up; a 30-minute walking training; and a 5-minute cool-down. The walking training will be conducted within a level-ground walking field. Participants will be instructed to look at and step on specific markers/labels that will be attached along the walking paths.

EXT
ControlBEHAVIORAL

Every training session will include the following activities for both groups: a 5-minute warm-up; a 30-minute walking training; and a 5-minute cool-down. The walking training will be conducted within a level-ground walking field. No markers/labels will be attached and no relevant instructions will be provided apart from the general instruction.

CON

Eligibility Criteria

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

You may qualify if:

  • aged 65 or above
  • able to walk independently indoor for at least 40 metres
  • static visual acuity score 20/40 or above
  • scoring 22/30 or above in the Montreal Cognitive Assessment Hong Kong version
  • without any history of untreated major neurological, vestibular or musculoskeletal deficits (e.g., stroke or Parkinson's disease)
  • without any unstable medical condition that can compromise safety during the experiment
  • scoring less than 24/28 in the Tinetti Balance Assessment Tool or scoring 50/56 or below in the Berg Balance Scale

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

June 5, 2025

First Posted

July 25, 2025

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

July 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share