Cerebrovascular AccidentsNCT01409265
The Impact of Perceptual Impairment on Social Participation in Stroke Patients
An observational study of Cerebrovascular Accidents, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cerebrovascular Accidents
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the rehabilitation department of hospitals
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cerebrovascular Accidents
- Keywords
- stroke rehabilitation, perceptual deficits
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 years
Secondary outcomes (13)
Box and Block Test (BBT)
The BBT is a test of manual dexterity and was originally developed to evaluate the gross manual dexterity of adults with cerebral palsy. A box with a partition directly in the center creating two equal sides is used in the test. Small wooden blocks are placed in one side of the box. The participant is required to use the unaffected had to grasp one block at a time and transport it over the partition and release it into the opposite side. 60 seconds is given to complete the test, and the number of blocks transported to the other side is counted. Then the participant is asked to repeat the same task with the affected hand. The BBT is administered 3 times during the study period.
Measured: Up to 3 years
Modified Ashworth Scale (MAS)
The MAS is a 5-point ordinal scale to evaluate muscle tone of upper-extremity. Higher scores indicate a more severe hypertonia. This measure is administered 3 times during the study period.
Measured: Up to 3 years
Medical Research Council scale (MRC)
The MRC scale assesses muscle power with scores ranging from 0 (no contraction) to 5 (normal power). The muscle strength of shoulder flexors/abductors, elbow flexors/extensors, wrist flexors/extensors, and finger extensors are graded. The MRC is administered 3 times during the study period.
Measured: Up to 3 years
Wolf Motor Function Test (WMFT)
The WMFT is used to assess the upper extremity function. The WMFT consists of 17 tasks, including 15 function tasks and 2 strength tasks. We only used the sum of the 15 functional tasks. The 15 functional tasks are timed (WMFT-TIME) and rated by using a 6-point functional ability scale (WMFT-FAS) where 0 indicates "does not attempt with the involved arm" and 5 represents "arm does participate; movement appears to be normal." The maximum score is 75. Higher scores are indicative of higher functioning levels. The WMFT is administered 3 times during the study period.
Measured: Up to 3 years
Action Research Arm Test (ARAT)
The ARAT is used to evaluate upper extremity function. It consists of 19 items, and tasks are scored on a 4-point scale. A maximum of a total score 57 indicates normal performance. This measure is administered 3 times during the study period.
Measured: Up to 3 years
Nottingham Extended Activities of Daily Living Scale (NEADL)
The NEADL scale is a measure of Instrumental ADL ability, comprising sub-scales for mobility, household ability and leisure activity. The NEADL consists of 22 activity items, scoring on the basis of the required level of assistance. The range of total score is 0-66, and higher score representing better function. This measure is administered 3 times during the study period.
Measured: Up to 3 years
Adelaide Activities Profile (AAP)
The AAP is used to assess life-style activities of the elderly. The AAP asks elderly people to provide responses which reflect their performance of 21 activities in a typical three-month period. Each activity is rated using four possible responses, scored 0, 1, 2 or 3 to indicate increasing frequency of activity. It consists of activities in domestic chores, household maintenance, service to others, and social activities. This measure is administered 3 times during the study period.
Measured: Up to 3 years
ABILHAND questionnaire
The ABILHAND questionnaire is a self report assessment that assesses the UE function that consists of 23 bilateral activities in the daily life. Patients were asked to estimate their difficulty in performing each activity.The ABILHAND is a 3-point ordinal scale, which the higher scores mean the more difficulty patients feel. This measure is administered 3 times during the study period.
Measured: Up to 3 years
Motor Activity Log (MAL)
The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate superior amount and quality of use in affected upper extremity. Each task is scored on a 6-point scale, ranging from 0 to 5. This measure is administered 3 times during the study period.
Measured: Up to 3 years
Stroke Impact Scale Version 3.0 (SIS 3.0)
The SIS 3.0 is a stroke-specific instrument of health-related quality of life and contains 59 items measuring 8 domains. Items are rated on a 5-point Likert scale with lower scores indicate greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain. It is administered 3 times during the study period.
Measured: Up to 3 years
Nottingham Leisure Questionnaire (NLQ)
The NLQ was developed to measure such decline in patients with a stroke and to monitor the effects of interventions on leisure. The NLQ lists 37 leisure items and has five possible response categories (very regularly, regularly, occasionally, infrequently, never). Higher scores denote a greater number of activities performed and/or greater frequency of activity. This measure is administered 3 times during the study period.
Measured: Up to 3 years
Leisure Satisfaction Scale (LSS)
The LSS evaluates the extent to which individuals feel that their needs are met through their leisure activities. The LSS included 24 Likert scale items (1=strongly disagree, 5=strongly agree). Categories included psychological, educational, social, relaxational, physiological, and aesthetic effects. A total score for each area and overall LSS score are calculated. This measure is administered 3 times during the study period.
Measured: Up to 3 years
Reintegration to Normal Living Index (RNLI)
The RNLI is an assessment of the quality of life (QOL) of people with disabilities. It includes 11 items. Concepts measured by the RNLI include mobility, self-care, daily activity, recreational activity, and family roles. The 100-point scale used a visual analog scale (VAS) anchored by opposing phrases. Higher scores indicate better QOL. This measure is administered 3 times during the study period.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Ching-yi Wu, ScD, Study director, Department of Occupational Therapy, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01409265
- Sponsor's protocol ID
- 99-3385B
- Status last verified
- Sep 2014
- First submitted
- 17 Mar 2011
- Last updated
- 11 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Perceptual Impairment on Social Participation in Stroke Patients
- ClinicalTrials.gov ID
- NCT01409265
- Acronym / sponsor ID
- 99-3385B
- Conditions
- Cerebrovascular Accidents
- Keywords
- stroke rehabilitation, perceptual deficits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan, National Health Research Institutes, Taiwan
- Study start
- Dec 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the rehabilitation department of hospitals
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: Up to 3 years
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.
13 secondary outcomes
Box and Block Test (BBT)
Time frame: Up to 3 years
Modified Ashworth Scale (MAS)
Time frame: Up to 3 years
Medical Research Council scale (MRC)
Time frame: Up to 3 years
Wolf Motor Function Test (WMFT)
Time frame: Up to 3 years
Action Research Arm Test (ARAT)
Time frame: Up to 3 years
Nottingham Extended Activities of Daily Living Scale (NEADL)
Time frame: Up to 3 years
Adelaide Activities Profile (AAP)
Time frame: Up to 3 years
ABILHAND questionnaire
Time frame: Up to 3 years
Motor Activity Log (MAL)
Time frame: Up to 3 years
Stroke Impact Scale Version 3.0 (SIS 3.0)
Time frame: Up to 3 years
Nottingham Leisure Questionnaire (NLQ)
Time frame: Up to 3 years
Leisure Satisfaction Scale (LSS)
Time frame: Up to 3 years
Reintegration to Normal Living Index (RNLI)
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2015.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ching-yi Wu, ScD study director
Department of Occupational Therapy, Chang Gung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accidents, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment (FMA) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2015.