NCT05367128

Brief Summary

The purpose of this single-blinded three-armed randomized controlled trial is to investigate the effect of different task prioritization during dual task training on dual task performance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 12, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

10 months

First QC Date

April 12, 2022

Last Update Submit

September 26, 2022

Conditions

Keywords

Older peoplePrioritization strategyDual task walkingDual task walking performance

Outcome Measures

Primary Outcomes (5)

  • Dual task walking performance assessment- speed (m/s)

    Using GaitUp system to evaluate gait speed during cognitive and motor dual task walking

    Change from baseline dual task walking speed and up to 6 weeks (pre- and post-test)

  • Dual task walking performance assessment- cadence (steps/min)

    Using GaitUp system to evaluate cadence during cognitive and motor dual task walking

    Change from baseline dual task walking cadence and up to 6 weeks (pre- and post-test)

  • Dual task walking performance assessment- stride length variability (CV, %)

    Using GaitUp system to evaluate stride length variability during cognitive and motor dual task walking

    Change from baseline dual task walking stride length variability and up to 6 weeks (pre- and post-test)

  • Dual task walking performance assessment- stride time variability (CV, %)

    Using GaitUp system to evaluate stride time variability during cognitive and motor dual task walking

    Change from baseline dual task walking stride time variability and up to 6 weeks (pre- and post-test)

  • Rate of dual task cost- gait speed (%)

    Using the dual and single task walking speed to calculate the dual task cost of gait speed

    Change from baseline dual task cost and up to 6 weeks (pre- and post-test)

Secondary Outcomes (8)

  • Trail Making Test

    Change from baseline Trail Making Test and up to 6 weeks (pre- and post-test)

  • Berg Balance Scale

    Change from baseline Berg Balance Scale and up to 6 weeks (pre- and post-test)

  • Single task walking performance assessment- speed (m/s)

    Change from baseline single task walking speed and up to 6 weeks (pre- and post-test)

  • Single task walking performance assessment- cadence (steps/min)

    Change from baseline single task walking cadence and up to 6 weeks (pre- and post-test)

  • Single task walking performance assessment- stride length variability (CV, %)

    Change from baseline single task walking stride length variability and up to 6 weeks (pre- and post-test)

  • +3 more secondary outcomes

Study Arms (3)

Posture-focus group

EXPERIMENTAL

Participants will be instructed to pay most attention to practice the posture task during training

Other: Dual task training

Supraposture-focus group

EXPERIMENTAL

Participants will be instructed to pay most attention to practice the cognitive task during training

Other: Dual task training

Control group

ACTIVE COMPARATOR

Participants will not be receive any instruction to prioritize either task

Other: Dual task training

Interventions

All participants will receive cognitive dual task training for 30 min/session, 2-3 sessions/week for 4-6 weeks (a total of 12 sessions). The cognitive dual task training includes 15 min of cognitive task combining with standing task and 15 min of cognitive task combining with walking task. The differences among group are the instructions of task prioritization given by the therapist

Control groupPosture-focus groupSupraposture-focus group

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 65 years old
  • MMSE scores \> 24

You may not qualify if:

  • Unstable health conditions
  • Any neurological, psychological disease or diagnosis of learning disability which interferes the participation in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

Study Officials

  • Ray-Yau Wang, PhD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ray-Yau Wang, PhD

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2022

First Posted

May 10, 2022

Study Start

July 25, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

September 28, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations