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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01693341 |
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Date of registration:
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20/09/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Caregiver-mediated Intervention Improves the Functional Ability of Home-living Chronic Stroke Patients
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Scientific title:
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Caregiver-mediated Intervention in Home-living Chronic Stroke Patients |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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50 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01693341 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research
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Phase:
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N/A
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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Alan. C Tsai, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Asia University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. >6 months post first stroke with mild to moderate disability (Brunnstrom stage III-V)
2. No longer undertaking active rehabilitation program(defined as =2 times/wk
rehabilitation activities)
Exclusion Criteria:
1. Recurring strokes
2. Mental or cognitive impairment
3. Severe orthopedic disability or unstable medical conditions (such as severe
rheumatoid arthritis or acute myocardial infarction)
4. Caregiver with mental/behavioral disorders
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Other: Care-giver mediated training
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Primary Outcome(s)
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Stroke Impact Scale
[Time Frame: Baseline and 12 weeks]
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Secondary Outcome(s)
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6-min walking distance
[Time Frame: Baseline and 12 weeks]
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Berg balance scale
[Time Frame: Baseline and 12 weeks]
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Fugl-Meyer Assessment Scale
[Time Frame: Baseline and 12 weeks]
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10-meter walking speed
[Time Frame: Baseline and 12 weeks]
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Lawton Instrumental Activities of Daily Living scale (IADL)
[Time Frame: Baseline and 12 weeks]
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Bathel index score
[Time Frame: Baseline and 12 weeks]
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Secondary ID(s)
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CT-tsaiac1943
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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