NCT03623841

Brief Summary

This study aimed to investigate the effects of dual-task training with exergame and treadmill on executive function and dual-task performance in individuals with PD and stroke and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

November 9, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2022

Completed
Last Updated

July 9, 2024

Status Verified

July 1, 2024

Enrollment Period

3.6 years

First QC Date

July 29, 2018

Last Update Submit

July 6, 2024

Conditions

Keywords

Executive functionDual-task performanceDual-task training

Outcome Measures

Primary Outcomes (1)

  • Dual-task walking performance

    To evaluate gait parameters while doing dual-task walking

    Change from baseline at 8 weeks

Secondary Outcomes (10)

  • Single walking performance

    Change from baseline at 8 weeks

  • Timed up and go test

    Change from baseline at 8 weeks

  • Parkinson's Disease Questionnaire 39

    Change from baseline at 8 weeks

  • Frontal lobe battery test-Chinese version

    Change from baseline at 8 weeks

  • Trail-making test

    Change from baseline at 8 weeks

  • +5 more secondary outcomes

Study Arms (2)

Dual-task training group

EXPERIMENTAL

Participants in dual-task training group will execute dual-task training via exer-game which combined with treadmill, 3 times per week, least 8 weeks.

Other: Dual-task training

Treadmill training group

ACTIVE COMPARATOR

Participants in treadmill training group will do treadmill training only, 3 times per week, least 8 weeks.

Other: Treadmill training

Interventions

Participants in experimental group will do dual-task training via exer-game which combined with treadmill

Dual-task training group

Participants in control group will do treadmill training only

Treadmill training group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as PD and Hoehn and Yahr stage between 1\~3
  • Age between 50 to 80
  • Able to walk 10 m independently without an assistive device
  • A score of greater than or equal to 24 on the mini-mental state examination (MMSE)
  • In stable medical condition allowing participation in the testing protocol and intervention

You may not qualify if:

  • Any comorbidity or disability other than PD that would preclude gait training
  • Any uncontrolled health condition for which exercise was contraindicated
  • Any neurological or orthopedic disease that might interfere with the study
  • Server freezing of gait, FOG questionnaire \> 15

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang-Ming university

Taipei, 112, Taiwan

Location

Related Publications (1)

  • Zhou JH, Wang RY, Liu YT, Cheng SJ, Liu HH, Yang YR. Effects of dual-task training on gait variability in individuals with Parkinson's disease: A randomized controlled trial. J Sci Med Sport. 2025 Dec;28(12):1012-1018. doi: 10.1016/j.jsams.2025.06.009. Epub 2025 Jun 20.

MeSH Terms

Conditions

Parkinson DiseaseStroke

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular Diseases

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

July 29, 2018

First Posted

August 9, 2018

Study Start

November 9, 2018

Primary Completion

June 30, 2022

Study Completion

August 9, 2022

Last Updated

July 9, 2024

Record last verified: 2024-07

Locations