Turning Pattern of Different Body Segments During Turns a... | NCT05929781

Studies
Turning Pattern of Different Body Segments During Turns and Turning Performance

NCT05929781

Sponsor

National Yang Ming Chiao Tung University

Status

Completed

Last Update Posted

Jun 13, 2025Actual

Enrollment

30Actual

Phase

Not provided

Conditions

Parkinson's Disease

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2023Actual

Primary Completion Date

Jul 21, 2024Actual

Completion Date

Aug 31, 2024Actual

First Submitted Date

Jun 21, 2023

First Submission Date that Met QC Criteria

Jun 29, 2023

First Posted Date

Jul 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2025

Last Update Posted Date

Jun 13, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yea-Ru Yang, Professor, National Yang Ming Chiao Tung UniversityPrincipal Investigator

Lead Sponsor

National Yang Ming Chiao Tung UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 (%).

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Young healthy adults		1. 20-39 years old
Middle to older healthy adults		40-80 years old age-matched with People with Parkinson's disease group
People with Parkinson's disease		40-80 years old Diagnosis of idiopathic Parkinson's disease Hoehn and Yahr stage 1-2

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Young healthy adults
Middle to older adults
People with Parkinson's disease

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yea-Ru Yang, Ph.D.	Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University		Taipei		112	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

This is a preliminary study and also with small sample size, so currently no plan to share data with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

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Browse Branches

Not provided