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NCT Number: NCT06588439

Cognitive-motor Training in Parkinson Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location status: Recruiting

Location contact

Yea-Ru Yang, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Cognitive-motor training

Other

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

Conventional Physiotherapy

Other

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

Primary outcomes

  1. Gait variability

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    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%

  2. Gait speed

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Using GAITRite system to measure gait speed

  3. Step length

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Using GAITRite system to measure step length

  4. Step width

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Using GAITRite system to measure step width

  5. Single support time

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Using GAITRite system to measure single support time

  6. Double support time

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Using GAITRite system to measure double support time

  7. Frontal Assessment Battery

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

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

  8. Stroop color and word test

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

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

  9. Digit span test

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    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.

  10. Event-related potential - N2

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

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

  11. Event-related potential - P300

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

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

  12. Go/Nogo test

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Behavioral test during measuring electroencephalography.

  13. Trail making test

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

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

Secondary outcomes

  1. Mini-Balance Evaluation Systems Test

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Mini-Balance Evaluation Systems Test scores range from 0 to 28. Higher scores indicate better balance ability.

  2. Montreal Cognitive Assessment

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Montreal Cognitive Assessment ranges from 0 to 30. Higher scores reflect better cognitive performances.

  3. Timed up and go test

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Record time of performing timed up and go test

  4. Parkinson Disease Questionnaire

    Time frame: Before and after 8 weeks of intervention, as well as 4 weeks after intervention

    Parkinson Disease Questionnaire assess quality of life in people with Parkinson disease. Lower scores reflect higher quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Yea-Ru Yang, PhD

CONTACT

[email protected]

+886228267279

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

Cognitive-motor Training on Brain Activity, Cognitive Function, and Walking Ability in People With Parkinson Disease

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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