A Preliminary Feasibility Efficacy of Participation in Daily Life Promotion Program

June 13, 2016 updated by: National Taiwan University Hospital

National Taiwan University Hospital, Taiwan

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Test2
      • Taipei, Test2, Taiwan, test3
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Daily Life Promotion Program
Other: Daily Life Promotion Program
Daily Life Promotion Program
Experimental: control group
general rehabilitation treatment
Other: general rehabilitation treatment
general rehabilitation treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural Assessment Scale for Stroke patients(PASS)
Time Frame: one year
motor performance measure
one year
Action Research Arm Test(ARAT)
Time Frame: one year
motor performance measure
one year
Fugl-Meyer Assessment(FMA)
Time Frame: one year
motor performance measure
one year
self-rated abilities for health practice scale
Time Frame: one year
self-efficacy factors measure
one year
WHO Quality of Life-BREF (Taiwan version)
Time Frame: one year
quality of life measure
one year
Taiwan Instrumental Activities of Daily Living(TIADL)
Time Frame: one year
self-care ability measure
one year
Barthel Index
Time Frame: one year
self-care ability measure
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: I MING HSIAO, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 13, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201509087RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Daily Life Promotion Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe