A Preliminary Feasibility Efficacy of Participation in Daily Life Promotion Program

Stroke Clinical Trial

Official title:

National Taiwan University Hospital, Taiwan

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02802956
• Other study ID #: 201509087RINC
• Status: Not yet recruiting
• Phase: N/A
• First received: June 3, 2016
• Last updated: June 13, 2016
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: June 2016
• Source: National Taiwan University Hospital
• Contact: I MING HSIAO
• Phone: 886-2-23123456*70420
• Email: skipbeat227[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Daily Life Promotion Program
Daily Life Promotion Program
• general rehabilitation treatment
general rehabilitation treatment

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Test2

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke Impact Scale(SIS)	quality of life measure	one year	No
Secondary	Postural Assessment Scale for Stroke patients(PASS)	motor performance measure	one year	No
Secondary	Action Research Arm Test(ARAT)	motor performance measure	one year	No
Secondary	Fugl-Meyer Assessment(FMA)	motor performance measure	one year	No
Secondary	self-rated abilities for health practice scale	self-efficacy factors measure	one year	No
Secondary	WHO Quality of Life-BREF (Taiwan version)	quality of life measure	one year	No
Secondary	Taiwan Instrumental Activities of Daily Living(TIADL)	self-care ability measure	one year	No
Secondary	Barthel Index	self-care ability measure	one year	No