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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04033393
Other study ID # 2019-05-005C
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date July 31, 2022

Study information

Verified date July 2019
Source National Yang Ming University
Contact Yang Yearu, Ph.D.
Phone +88628267279
Email yryang@ym.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to investigate the effects of Game based dual-task training with treadmill on executive function and dual-task performance in individuals with early-onset PD and discuss the correlation between the change values of executive function and dual-task performance after training. Besides, investigate cortical activation after training.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date July 31, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosed as PD and Hoehn and Yahr stage between 1~3

- Age between 20 to 80

- Able to walk 10 m independently without an assistive device

- A score of greater than or equal to 24 on the mini-mental state examination (MMSE)

- In stable medical condition allowing participation in the testing protocol and intervention

Exclusion Criteria:

- Any comorbidity or disability other than PD that would preclude gait training

- Any uncontrolled health condition for which exercise was contraindicated

- Any neurological or orthopedic disease that might interfere with the study

- Server freezing of gait, FOG questionnaire > 15

Study Design


Intervention

Other:
Game based dual-task training
Participants in the experimental group will receive game based dual-task training with a treadmill
Treadmill training
Participants in the control group will receive treadmill training

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Outcome

Type Measure Description Time frame Safety issue
Primary Dual-task walking performance To evaluate gait parameters while doing dual-task walking Change from baseline at 8 weeks
Secondary Single walking performance To evaluate gait parameters while doing single walking Change from baseline at 8 weeks
Secondary Timed up and go test To evaluate functional walking ability Change from baseline at 8 weeks
Secondary Parkinson's Disease Questionnaire 39 To evaluate the quality of life Change from baseline at 8 weeks
Secondary Frontal lobe battery test-Chinese version To evaluate executive function Change from baseline at 8 weeks
Secondary Trail-making test To evaluate executive function Change from baseline at 8 weeks
Secondary Stroop color and word test-Chinese version To evaluate executive function Change from baseline at 8 weeks
Secondary Verbal fluency test-Chinese version To evaluate executive function Change from baseline at 8 weeks
Secondary Digit span test To evaluate executive function Change from baseline at 8 weeks
Secondary Dual-task costs To compare the cost between doing dual task and single task Change from baseline at 8 weeks
Secondary Functional near-infrared spectroscopy To evaluate the changes of blood perfusion in frontal lobe Change from baseline at 8 weeks
See also
  Status Clinical Trial Phase
Completed NCT00335166 - SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson Disease Phase 3