Visual and Tactile Scanning Training in Patients With Neglect After Stroke
ViTaTrain
1 other identifier
interventional
16
1 country
1
Brief Summary
The purpose of this study is to evaluate whether 20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation will be feasible and provide better results compared to 20 Sessions of 30 minutes of a standard visual scanning programme.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 5, 2014
December 1, 2014
9 months
November 9, 2014
December 4, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale
Measured with the Catherine Bergego Scale
up to 14 months
Adherence rate of the patients to the treatment
up to 11 months
Secondary Outcomes (9)
Visual neglect measured with the Behavioural Inattention Test (conventional subtest)
up to 14 months
Severity of disability in a rehabilitation setting measured with the Functional Independence Measure
up to 11 months
Personal neglect measured with the Vest Test
up to 14 months
Mobility related disability easured with the Rivermead Mobility Index
up to 11 months
Health related quality of life measured with the EQ-5D
up to 14 months
- +4 more secondary outcomes
Study Arms (2)
Visual and tactile scanning training
EXPERIMENTAL20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation
Unimodal visual scanning training
ACTIVE COMPARATOR20 sessions of 30 minutes with traditional uni-modal visual scanning training
Interventions
20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space and trunk rotation. The intervention includes visual or tactile scanning training in three different spaces and will be individually adapted to the needs of the patients. 1. Visual or tactile scanning in the personal space 2. Visual or tactile scanning and trunk rotation in the peripersonal space 3. Visual scanning and trunk rotation in the extrapersonal space
20 sessions of 30 minutes with traditional uni-modal visual scanning training in the peripersonal space.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Berner Klinik Montana
Montana, Valais, 3963, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Sattelmayer, MSc, MA
HES-SO Valais-Wallis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2014
First Posted
December 5, 2014
Study Start
December 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
December 5, 2014
Record last verified: 2014-12