NCT01409265

Brief Summary

The perceptual change on stroke patients during the movement recovery and its relationship with social participation still remain unclear. The purposes of this study are: 1) to observe the progression of perception deficit and 2) to understand the relationships among perception deficit and other functional indicators. A total of 90 stroke patients will be recruited. Each patient will receive three times evaluation, including perception tests, motor function test, daily living ability tests and social leisure participation questionnaires.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 11, 2015

Status Verified

September 1, 2014

Enrollment Period

3 years

First QC Date

March 17, 2011

Last Update Submit

February 10, 2015

Conditions

Keywords

stroke rehabilitationperceptual deficits

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment (FMA)

    The FMA is used to evaluate stroke-related motor impairment, including upper- and lower-extremity movements, sensation, and balance. The whole FMA takes approximately 30 to 40 minutes to administer. The upper-extremity subscale of the FMA contains 33 items to assess motor impairment. Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly). It is administered 3 times during the study period.

    Up to 3 years

Secondary Outcomes (13)

  • Box and Block Test (BBT)

    Up to 3 years

  • Modified Ashworth Scale (MAS)

    Up to 3 years

  • Medical Research Council scale (MRC)

    Up to 3 years

  • Wolf Motor Function Test (WMFT)

    Up to 3 years

  • Action Research Arm Test (ARAT)

    Up to 3 years

  • +8 more secondary outcomes

Study Arms (1)

No treatment

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

the rehabilitation department of hospitals

You may qualify if:

  • the age over 40 years old
  • the time of onset more than 3 months
  • no cognitive dysfunction
  • cerebral stroke
  • clinical diagnosis of a first or recurrent unilateral stroke

You may not qualify if:

  • recurrent of the stroke or epilepsy during the intervention
  • patients with the neurological or psychical history, for example, alcoholism, drug poisoning or bipolar disorder
  • participate in the other interventional study in the same time
  • refuse subscribed the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chia-ling Chen

Kwei-Shan, Toayuan County, 333, Taiwan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Ching-yi Wu, ScD

    Department of Occupational Therapy, Chang Gung University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2011

First Posted

August 4, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 11, 2015

Record last verified: 2014-09

Locations