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A Preliminary Feasibility Efficacy of Participation in Daily Life Promotion Program

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02802956
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
30
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Daily Life Promotion Program
  • Other: general rehabilitation treatment
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
National Taiwan University Hospital, Taiwan
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Stroke Impact Scale(SIS) [one year]

    quality of life measure

Secondary Outcome Measures

  1. Postural Assessment Scale for Stroke patients(PASS) [one year]

    motor performance measure

  2. Action Research Arm Test(ARAT) [one year]

    motor performance measure

  3. Fugl-Meyer Assessment(FMA) [one year]

    motor performance measure

  4. self-rated abilities for health practice scale [one year]

    self-efficacy factors measure

  5. WHO Quality of Life-BREF (Taiwan version) [one year]

    quality of life measure

  6. Taiwan Instrumental Activities of Daily Living(TIADL) [one year]

    self-care ability measure

  7. Barthel Index [one year]

    self-care ability measure

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Test2 Taiwan test3

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02802956
Other Study ID Numbers:
  • 201509087RINC
First Posted:
Jun 16, 2016
Last Update Posted:
Jun 16, 2016
Last Verified:
Jun 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by National Taiwan University Hospital
Life participation

Study Results

No Results Posted as of Jun 16, 2016