NCT02802956

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

June 3, 2016

Last Update Submit

June 13, 2016

Conditions

Keywords

Life participation

Outcome Measures

Primary Outcomes (1)

  • Stroke Impact Scale(SIS)

    quality of life measure

    one year

Secondary Outcomes (7)

  • Postural Assessment Scale for Stroke patients(PASS)

    one year

  • Action Research Arm Test(ARAT)

    one year

  • Fugl-Meyer Assessment(FMA)

    one year

  • self-rated abilities for health practice scale

    one year

  • WHO Quality of Life-BREF (Taiwan version)

    one year

  • +2 more secondary outcomes

Study Arms (2)

intervention group

EXPERIMENTAL

Daily Life Promotion Program

Other: Daily Life Promotion Program

control group

EXPERIMENTAL

general rehabilitation treatment

Other: general rehabilitation treatment

Interventions

Daily Life Promotion Program

intervention group

general rehabilitation treatment

control group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Test2, test3, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • I MING HSIAO

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2016

First Posted

June 16, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

June 16, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations