Impairment-Specific and Augmented Intervention on Turning | NCT04438343

Studies
Impairment-Specific and Augmented Intervention on Turning

NCT04438343

Sponsor

National Yang Ming Chiao Tung University

Status

Unknown status

Last Update Posted

Jun 22, 2021Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

Impairment-specific and augmented intervention
Conventional physical therapy

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 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2020Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Jun 16, 2020

First Submission Date that Met QC Criteria

Jun 16, 2020

First Posted Date

Jun 18, 2020Actual

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 18, 2021

Last Update Posted Date

Jun 22, 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)

Not provided

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

The objective of this study is to investigate the effects of the impairment-specific and augmented intervention based balance and strength training on turning performance in individuals with chronic stroke.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental group	Experimental		Other: Impairment-specific and augmented intervention
control group	Active Comparator		Other: Conventional physical therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Impairment-specific and augmented intervention	Other	Balance and lower extremities strength training	experimental group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Turning performance	Using a turning characteristic evaluation system to evaluate the swing time, stance time, turning speed, and stride length of the participants during turning	Change from baseline at 4 week

Secondary Outcomes

Measure	Description	Time Frame
Balance	Berg Balance Scale Limits of stability (LOS) using NeuroCom Smart Balance Master (NeuroCom International, Clackamas, OR)	Change from baseline at 4 week
Strength	Using handheld dynamometer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≧ 6 months post first-ever stroke with unilateral motor deficits
≧20 years of age
The ability to walk independently for at least 7 m with or without using walking aids
Score ≧ 24 of 30 on the Mini-Mental State Examination

Exclusion Criteria:

Unstable medical conditions (e.g., deep vein thrombosis, aspiration pneumonia, or superimposed sepsis)
History of other diseases known to interfere with participation in the study (e.g., heart failure, hemineglect, or diabetic neuropathy)

Accepts Healthy Volunteers

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yea-Ru Yang	Contact	+886228267279		yryang@nycu.edu.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yea-Ru Yang	Recruiting	Taipei	Beitou	112	Taiwan

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