NCT06588439

Brief Summary

Literature reviews showed the cognitive-motor training that combines cognitive tasks may enhance cognitive functions more effectively than individual interventions. Stepping-based cognitive-motor training has been shown to improve cognitive functions, balance, and gait performance in older adults. However, there is insufficient research evidence on the impact and correlation of this training mode on the walking ability, executive functions, and brain activity changes in people with PD. Therefore, this study is designed to investigate the effects of stepping-based cognitive-motor training on the walking ability, executive functions, and brain activity in people with PD.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
16mo left

Started Mar 2025

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress47%
Mar 2025Aug 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
6 months until next milestone

Study Start

First participant enrolled

March 15, 2025

Completed
2.5 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

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

2.5 years

First QC Date

September 5, 2024

Last Update Submit

June 11, 2025

Conditions

Parkinson Disease

Keywords

Cognitive-motor trainingExecutive 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%

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Gait speed

    Using GAITRite system to measure gait speed

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Step length

    Using GAITRite system to measure step length

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Step width

    Using GAITRite system to measure step width

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Single support time

    Using GAITRite system to measure single support time

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Double support time

    Using GAITRite system to measure double support time

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Frontal Assessment Battery

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

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Stroop color and word test

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

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • 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.

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Event-related potential - N2

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

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Event-related potential - P300

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

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Go/Nogo test

    Behavioral test during measuring electroencephalography.

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Trail making test

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

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Secondary Outcomes (4)

  • Mini-Balance Evaluation Systems Test

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Montreal Cognitive Assessment

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Timed up and go test

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

  • Parkinson Disease Questionnaire

    Before and after 8 weeks of intervention, as well as 4 weeks after intervention

Study Arms (2)

Cognitive-motor training group

EXPERIMENTAL

Participants receive 16 sessions of cognitive-motor training.

Other: Cognitive-motor training

Control group

ACTIVE COMPARATOR

Participants receive 16 sessions of conventional physiotherapy.

Other: Conventional physiotherapy

Interventions

Cognitive-motor trainingOTHER

Cognitive-motor training is that cognitive tasks incorporated into motor tasks.

Cognitive-motor training group
Conventional physiotherapyOTHER

Conventional physiotherapy includes stretching, ROM exercise, strengthening exercise, and eye-hand coordination.

Control group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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 (1)

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

+886228267279yryang@nycu.edu.tw

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

September 5, 2024

First Posted

September 19, 2024

Study Start

March 15, 2025

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations

TW(1)