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

Parkinson Disease(PD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06355947
• Other study ID #: 103-7445B
• Status: Completed
• Phase: N/A
• Start date: December 7, 2015
• Est. completion date: July 31, 2018

Study information

• Verified date: April 2024
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 31, 2018
• Est. primary completion date: September 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson Disease(PD)

Intervention

Other:
• Cognitive cycling training
Cycling training conducted with cognitive tasks
• Cognitive treadmill training
Treadmill training conducted with cognitive tasks

Locations

Country	Name	City	State
Taiwan	Chang Gung University	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking Speed	The time taken by participants to walk a standardized distance, typically expressed in centimeters per second (cm/s).	Baseline, 4 weeks and 8 weeks
Primary	Step Length	The linear distance between the two ankles, typically expressed in centimeters(cm).	Baseline, 4 weeks and 8 weeks
Primary	Step Time	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.	Baseline, 4 weeks and 8 weeks
Primary	Power Spectral Density (PSD)	Quantifies the power of EEG signals within specific frequency bands (e.g., delta, theta, alpha, beta, and gamma) over a period.	Baseline, 4 weeks and 8 weeks.
Primary	Task Accuracy	The percentage of correct responses or actions made by participants in response to walking or cycling tasks.	Baseline, 4 weeks and 8 weeks.
Primary	Reaction Time	The duration between the onset of task start time and the participant's response to it, typically expressed in second (s).	Baseline, 4 weeks and 8 weeks.
Primary	Balance Performance	Measured by the duration the stance can be maintained, typically expressed second.	Baseline, 4 weeks and 8 weeks
Secondary	Double Support Time	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.	Baseline, 4 weeks and 8 weeks
Secondary	Single Support Time	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.	Baseline, 4 weeks and 8 weeks
Secondary	Swing Time	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.	Baseline, 4 weeks and 8 weeks
Secondary	Stance Time	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	Baseline, 4 weeks and 8 weeks
Secondary	Cadence	The number of steps an individual takes per minute, providing an overview of gait speed and rhythm, , expressed as steps per minute.	Baseline, 4 weeks and 8 weeks
Secondary	Heart rate	The number of heartbeats per minute on resting, walking or cycling tasks.	Baseline