NCT06588920

Brief Summary

The dual-task automated walking performance in people with Parkinson\'s disease (PD) is affected by their gait disturbances and impaired executive functions. Currently, the relationship between brain activity related to inhibitory control, executive functions, and dual-task walking performance in people with PD is not well understood. Therefore, this study aims to investigate the significance of different executive function domains on gait stability in healthy older adults and people with PD; whether brain activation related to inhibitory control is associated with gait stability in healthy older adults and people with PD.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
16mo left

Started Oct 2024

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
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 Progress55%
Oct 2024Aug 2027

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

October 9, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

2.9 years

First QC Date

September 5, 2024

Last Update Submit

March 20, 2026

Conditions

Keywords

Executive functionGaitElectroencephalography

Outcome Measures

Primary Outcomes (13)

  • Gait variability

    Using GAITRite system to measure the coefficient of variation (CV). The mean and standard deviation will be used to calculate the coefficient of variation (CV). CV = standard deviation / mean \* 100%

    1 day

  • Gait speed

    Using GAITRite system to measure gait speed.

    1 day

  • Step length

    Using GAITRite system to measure step length

    1 day

  • Step width

    Using GAITRite system to measure step width.

    1 day

  • Single support time

    Using GAITRite system to measure single support time

    1 day

  • Double support time

    Using GAITRite system to measure double support time

    1 day

  • Frontal Assessment Battery

    The score ranged from 0 to 18. Higher scores show better executive function.

    1 day

  • Trail making test

    Trail making test contain part A and part B. Faster completing the test indicates better executive function.

    1 day

  • Stroop color and word test

    Record numbers of corrected color words which the subject responds within 45 sec.

    1 day

  • Digit span test

    Digit span test contain forward and backward part. Scores of forward digit span ranges from 0 to 16. Score of backward digit span ranges from 0 to 14. Higher scores indicate better executive function.

    1 day

  • Event-related potential - N2

    Measure event-related potential through electroencephalography under single-task and dual-task paradigm.

    1 day

  • Event-related potential - P300

    Measure event-related potential through electroencephalography under single-task and dual-task paradigm.

    1 day

  • Go/Nogo test

    Behavioral test during measuring electroencephalography.

    1 day

Study Arms (2)

Parkinson disease

People with Parkinson disease

Behavioral: Cognitive function, gait, and electroencephalogram

Healthy older adults

Healthy older adults

Behavioral: Cognitive function, gait, and electroencephalogram

Interventions

Measurement of cognitive function, gait performance, and electroencephalogram

Healthy older adultsParkinson disease

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital and community

You may qualify if:

  • Diagnoses of idiopathic Parkinson disease
  • Stable dopaminergic medicine ≥ 2 weeks
  • Able to walk 10 meters without aid
  • Mini-Mental Status Examination ≥ 24 points
  • No uncorrected visual or auditory disorders
  • Education at least junior high school
  • No other disease may affect balance

You may not qualify if:

  • Other medical diagnoses of neurological, musculoskeletal, or cardiopulmonary disorders
  • History of brain surgery (e.g. deep brain stimulation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Yang Ming Chiao Tung University

Taipei, Taiwan

RECRUITING

National Yang Ming Chiao Tung University

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Gait

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

October 9, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations