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Completed

NCT Number: NCT06355947

Cycling and Treadmill With Dual Task for Parkinson's Disease Improvement

Motor impairment in lower extremities is common in individuals with Parkinson disease (PD). Development sensitive test for early motor deviations is important. Conventional walking test cannot induce the PD related motor impairments, such as freezing of gait. Therefore, finding a safe substitute test to induce PD related motor impairments is important.

Studies showed that working memory related dual task walking was a sensitive test for PD. However, the optimal cognitive test needs to be clarified. Studies also showed that the neuromuscular control mechanism of leg movements during cycling were similar to those during walking. Therefore, dual task cycling test is potential to be a safe and sensitive testing model.

Studies showed that exercise could improve cognitive function and induce brain plasticity. Dual task exercise training was shown to be more effective than single task exercise training for older people to prevent fall. Whether the added cognitive task could improve to detriment brain plasticity in PD should be investigated. Transcranial magnetic stimulation can evaluate the motor cortex plasticity on-invasively and can evaluate the exercise induced brain plasticity.

The purpose of this three-year project is to develop PD-sensitive. The purposes of the first year are to translate the dual task walking test to dual task cycling test, and to establish the reliability of the dual task cycling test.

The purposes of the second year are to compare the motor cortex plasticity induced by single task cycling versus dual task cycling and to compare the difference response between PD and healthy control people.

The purpose of the third year is to evaluate the effect of 8 week long term cycling training or treadmill training of individuals with PD on motor cortex plasticity, dual task performance, and ambulation ability.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University

Taoyuan, 333, Taiwan

Who can participate

Healthy volunteers accepted: Yes

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

Health subjects:

Exclusion criteria

  • Musculoskeletal injuries on legs.
  • Osteoporosis.

PD subjects:

Inclusion criteria

  • Clinical diagnosis of Parkinson disease.

Exclusion criteria

  • Musculoskeletal injuries on legs
  • Osteoporosis.
  • Any peripheral or central nervous system injury or disease patients.

Treatment and study plan

Cognitive cycling training

Other

Cycling training conducted with cognitive tasks

Cognitive treadmill training

Other

Treadmill training conducted with cognitive tasks

Primary outcomes

  1. Walking Speed

    Time frame: Baseline, 4 weeks and 8 weeks

    The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).

  2. Step Length

    Time frame: Baseline, 4 weeks and 8 weeks

    The linear distance between the two ankles, typically expressed in centimeters(cm).

  3. Step Time

    Time frame: Baseline, 4 weeks and 8 weeks

    The duration taken for one complete step, measuring from foot-off of one foot to the next foot-off of the same foot, usually expressed in seconds.

  4. Power Spectral Density (PSD)

    Time frame: Baseline, 4 weeks and 8 weeks.

    Quantifies the power of EEG signals within specific frequency bands (e.g., delta, theta, alpha, beta, and gamma) over a period.

  5. Task Accuracy

    Time frame: Baseline, 4 weeks and 8 weeks.

    The percentage of correct responses or actions made by participants in response to walking or cycling tasks.

  6. Reaction Time

    Time frame: Baseline, 4 weeks and 8 weeks.

    The duration between the onset of task start time and the participant's response to it, typically expressed in second (s).

  7. Balance Performance

    Time frame: Baseline, 4 weeks and 8 weeks

    Measured by the duration the stance can be maintained, typically expressed second.

Secondary outcomes

  1. Double Support Time

    Time frame: Baseline, 4 weeks and 8 weeks

    The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.

  2. Single Support Time

    Time frame: Baseline, 4 weeks and 8 weeks

    The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle.

  3. Swing Time

    Time frame: Baseline, 4 weeks and 8 weeks

    The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step. It is usually expressed as a percentage of the total gait cycle or in seconds.

  4. Stance Time

    Time frame: Baseline, 4 weeks and 8 weeks

    The portion of the gait cycle when the foot is in contact with the ground, supporting body weight. It's typically expressed as a percentage of the total gait cycle or in seconds

  5. Cadence

    Time frame: Baseline, 4 weeks and 8 weeks

    The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.

  6. Heart rate

    Time frame: Baseline

    The number of heartbeats per minute on resting, walking or cycling tasks.

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Registry information

Official study title

Cycling Induced Motor Cortex Plasticity and Functional Improvement -the Dual Task Evaluation Model for Parkinson Disease

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

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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