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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: |
NCT02309853 |
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Date of registration:
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09/11/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Visual and Tactile Scanning Training in Patients With Neglect After Stroke
ViTaTrain |
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Scientific title:
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Visual and Tactile Scanning Training in Patients With Neglect After Stroke |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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16 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02309853 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Switzerland
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Contacts
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Name:
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Martin Sattelmayer, MSc, MA |
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Address:
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Telephone:
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Email:
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Affiliation:
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HES-SO Valais-Wallis |
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Name:
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Martin Sattelmayer, MA, MSc |
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Address:
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Telephone:
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Email:
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martin.sattelmayer@hevs.ch |
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Affiliation:
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Name:
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Martin Sattelmayer, MSc, MA |
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Address:
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Telephone:
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Email:
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martin.sattelmayer@hevs.ch |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- First or second time right hemispheric stroke (haemorrhagic or ischaemic, diagnosed
with computer tomography or magnetic resonance imaging)
- Time after last stroke: less than 8 weeks
- Hemispatial neglect with at least seven points on the Catherine Bergego Scale
- Right handed
Exclusion Criteria:
- Reduced vision after rectification (i.e. corrected vision sufficient to read
newspaper-sized print)
- Mini-Mental State Evaluation Score below 11
- Not fluently speaking and understanding French or German language in order to
understand the tasks and the assessments, as assessed and judged by the medical
doctor and the staff.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hemispatial Neglect
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Intervention(s)
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Other: Uni-modal visual scanning training
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Other: Visual and tactile scanning training
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Primary Outcome(s)
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Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale
[Time Frame: up to 14 months]
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Adherence rate of the patients to the treatment
[Time Frame: up to 11 months]
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Secondary Outcome(s)
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Visual neglect measured with the Behavioural Inattention Test (conventional subtest)
[Time Frame: up to 14 months]
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Completeness of documents
[Time Frame: up to 11 months]
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Health related quality of life measured with the EQ-5D
[Time Frame: up to 14 months]
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Mobility related disability easured with the Rivermead Mobility Index
[Time Frame: up to 11 months]
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Personal neglect measured with the Vest Test
[Time Frame: up to 14 months]
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Severity of disability in a rehabilitation setting measured with the Functional Independence Measure
[Time Frame: up to 11 months]
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Inclusion rate and refusal rate per week
[Time Frame: up to 11 months]
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Length of stay in inpatient rehabilitation setting
[Time Frame: up to 11 months]
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Length of time of assessments
[Time Frame: up to 11 months]
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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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