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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05929781
Other study ID # NYCU112100AE
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2024

Study information

Verified date August 2023
Source National Yang Ming University
Contact Yea-Ru Yang, Ph.D.
Phone 28267000
Email yryang@nycu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a cross-sectional exploratory study. A total of 25 people with PD, 25 young healthy adults, and 25 middle to older adults will be recruited. Axial segment turning pattern and turning performance will be evaluated in two visits using the Vicon 3D motion analysis system, Gaitup, and 3D motion camera. The independent variables are the initiation timing of the head, upper trunk, pelvis, ankle, and foot when turning and the initiation sequence of turning (% turn). The dependent variables are turning performance, including turning velocity, turning steps, turning step length, turning step width), and stance phase (%).


Description:

The first aim of the present study is to explore the correlation between axial segment turning pattern and turning performance in people with PD and healthy adults. The second aim is to verify the validity and reliability of 3D motion camera in turning evaluation. A total of 25 people with PD, 25 young healthy adults, and 25 middle to older adults will be recruited. Axial segment turning pattern and turning performance will be evaluated in two visits using the Vicon 3D motion analysis system, Gaitup, and 3D motion camera. The independent variables are the initiation timing of the head, upper trunk, pelvis, ankle, and foot when turning and the initiation sequence of turning (% turn). The dependent variables are turning performance, including turning velocity, turning steps, turning step length, turning step width), and stance phase (%). For the data analysis, the Shapiro-Wilk test will be used to check for normal distribution. Pearson's correlation coefficient or Spearman's rank correlation coefficient will be used to examine the correlations between axial segment initiation timing and turning performance. To verify the validity and reliability, Pearson's correlation coefficient will be used for concurrent criterion validity. Intraclass correlation one-way random model will be used for test-retest reliability, showed with intraclass correlation coefficient and 95% confidence interval. A p-value of less than 0.05 is considered statistically significant.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date December 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Able to walk 5 meters without assistance device - Able to turn independently Exclusion Criteria: - With neurological disorders - MMSE< 24 - Any systemic and musculoskeletal disturbances or other causes of walking inability

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Initiation timing (sec) Initiation timing of the head, upper trunk, pelvis, ankle, and foot when turning Change from baseline at one week
Primary Turning velocity (cm/sec) Change from baseline at one week
Primary Turning steps Change from baseline at one week
Primary Turning step length (cm) Change from baseline at one week
Primary Turning step width (cm) Change from baseline at one week
Primary Stance phase (%) Change from baseline at one week
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