Turning Performance in Stroke | NCT05020886

Studies
Turning Performance in Stroke

NCT05020886

Sponsor

National Yang Ming Chiao Tung University

Status

Unknown status

Last Update Posted

Aug 25, 2021Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Stroke

Interventions

turning task

Countries

Not provided

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

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2021Estimated

Primary Completion Date

Jul 31, 2024Estimated

Completion Date

Jul 31, 2024Estimated

First Submitted Date

Aug 21, 2021

First Submission Date that Met QC Criteria

Aug 21, 2021

First Posted Date

Aug 25, 2021Actual

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

Aug 21, 2021

Last Update Posted Date

Aug 25, 2021Actual

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

Turning is a challenging task for stroke patient. Previous studies showed that turning is one of the activities which resulting in falling frequently in stroke. However, the assessment tool of turning performance is still lack of reliability and validity. Furthermore, the main factors which affected turning ability in stroke are not approved yet.

Detailed Description

Not provided

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy			Behavioral: turning task
Stroke			Behavioral: turning task

Interventions

Name	Type	Description	Arm Group Labels	Other Names
turning task	Behavioral	Several trials included bilateral turning in 30, 60, 90, 120, 150, 180 degree.	Healthy Stroke

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Turning angle		10 minutes
Turning time		10 minutes
Turning step		10 minutes
Single leg supported time during turning		10 minutes
Swing time during turning		10 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6 months after first stroke.
Able to independently walk 7 meter at least without any device
MMSE score ≧ 24

Exclusion Criteria:

Unstable medical conditions (such as deep vein thrombosis)
Any disease which has known affecting walk(heart failure, diabetes)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stroke

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yea-Ru Yang, Ph.D.	Contact	+886-2-2826-7279		yryang@nycu.edu.tw

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided