A Preliminary Feasibility Efficacy of Participation in Da... | NCT02802956

Studies
A Preliminary Feasibility Efficacy of Participation in Daily Life Promotion Program

NCT02802956

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jun 16, 2016Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

Daily Life Promotion Program
general rehabilitation treatment

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 2016

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

Jun 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Jun 3, 2016

First Submission Date that Met QC Criteria

Jun 13, 2016

First Posted Date

Jun 16, 2016Estimated

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 13, 2016

Last Update Posted Date

Jun 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Efficacy of Participation in Daily Life Promotion Program for Patients with Chronic Stroke

Detailed Description

The purpose of this three-year research project is to develop an intervention program to promote participation in daily life for patients with chronic stroke and to evaluate its efficacy.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention group	Experimental	Daily Life Promotion Program	Other: Daily Life Promotion Program
control group	Experimental	general rehabilitation treatment	Other: general rehabilitation treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Daily Life Promotion Program	Other	Daily Life Promotion Program	intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stroke Impact Scale(SIS)	quality of life measure	one year

Secondary Outcomes

Measure	Description	Time Frame
Postural Assessment Scale for Stroke patients(PASS)	motor performance measure	one year
Action Research Arm Test(ARAT)	motor performance measure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient with stroke after 6 months.
Must be able to follow orders and no other cognition impairment, Mini Mental State Examination scale must >20.

Exclusion Criteria:

Clinical diagnosis of Dementia or Psychosis.
Clinical diagnosis of Musculoskeletal disorders or Nervous system diseases.
Patient with Congestive Heart Failure, Hypertension, Atrial fibrillation.
Could not communication with others.
Foreigner.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
I MING HSIAO	Contact	886-2-23123456*70420		skipbeat227@gmail.com
Yi-Jiun Yang	Contact	886-2-23123456*66763		skipbeat227@gmail.com

Overall Officials

Name	Affiliation	Role
I MING HSIAO	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei	Test2	test3	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

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