Clinical trial NCT01409265: The Impact of Perceptual Impairment on Social Participation in Stroke Patients
Official title: The Impact of Perceptual Impairment on Social Participation in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrovascular Accidents
Keywords: stroke rehabilitation
perceptual deficits
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
name: National Health Research Institutes, Taiwan
First posted: 2011-08-04
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the rehabilitation department of hospitals

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.

Detailed description: According to motor control theory, perception plays an important role in the execution of motion. Although the effect of rehabilitation for motor recovery on stroke patients has been well established, the perceptual change during the movement recovery and its relationship with social participation still remain unclear.

A total of 90 stroke patients will be recruited. Each patient will receive initial evaluation, first follow-up evaluation after four weeks and second follow-up evaluation after five months. The contents include basic clinical screen tests, perception tests, motor function test, daily living ability tests and social leisure participation questionnaires.

The purposes of this study are: 1) to observe the change of the during the experiment and clarify the progression of perception deficit and 2) to understand the relationships among perception deficit and the other functional indicators and determine the impact of perception deficit on activities and participation in stroke patients.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Box and Block Test (BBT)
timeFrame: Up to 3 years
measure: Modified Ashworth Scale (MAS)
timeFrame: Up to 3 years
measure: Medical Research Council scale (MRC)
timeFrame: Up to 3 years
measure: Wolf Motor Function Test (WMFT)
timeFrame: Up to 3 years
measure: Action Research Arm Test (ARAT)
timeFrame: Up to 3 years
measure: Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Up to 3 years
measure: Adelaide Activities Profile (AAP)
timeFrame: Up to 3 years
measure: ABILHAND questionnaire
timeFrame: Up to 3 years
measure: Motor Activity Log (MAL)
timeFrame: Up to 3 years
measure: Stroke Impact Scale Version 3.0 (SIS 3.0)
timeFrame: Up to 3 years
measure: Nottingham Leisure Questionnaire (NLQ)
timeFrame: Up to 3 years
measure: Leisure Satisfaction Scale (LSS)
timeFrame: Up to 3 years
measure: Reintegration to Normal Living Index (RNLI)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Kwei-Shan, Toayuan county
country: Taiwan
facility: Chia-ling Chen
Study officials:
affiliation: Department of Occupational Therapy, Chang Gung University
name: Ching-yi Wu, ScD
role: STUDY_DIRECTOR
References: