Visual and Tactile Scanning Training in Patients With Neglect After Stroke (ViTaTrain)
Primary Purpose
Hemispatial Neglect
Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Visual and tactile scanning training
Uni-modal visual scanning training
Sponsored by
About this trial
This is an interventional treatment trial for Hemispatial Neglect
Eligibility Criteria
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.
Sites / Locations
- Berner Klinik MontanaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Visual and tactile scanning training
Unimodal visual scanning training
Arm Description
20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation
20 sessions of 30 minutes with traditional uni-modal visual scanning training
Outcomes
Primary Outcome Measures
Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale
Measured with the Catherine Bergego Scale
Adherence rate of the patients to the treatment
Secondary Outcome Measures
Visual neglect measured with the Behavioural Inattention Test (conventional subtest)
Measured with the Behavioural Inattention Test (conventional subtest)
Severity of disability in a rehabilitation setting measured with the Functional Independence Measure
Measured with the Functional Independence Measure
Personal neglect measured with the Vest Test
Measured with the Vest Test
Mobility related disability easured with the Rivermead Mobility Index
Measured with the Rivermead Mobility Index
Health related quality of life measured with the EQ-5D
Measured with the EQ-5D
Length of stay in inpatient rehabilitation setting
Inclusion rate and refusal rate per week
Completeness of documents
Length of time of assessments
Full Information
NCT ID
NCT02309853
First Posted
November 9, 2014
Last Updated
December 4, 2014
Sponsor
HES-SO Valais-Wallis
Collaborators
University of Applied Sciences of Western Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT02309853
Brief Title
Visual and Tactile Scanning Training in Patients With Neglect After Stroke
Acronym
ViTaTrain
Official Title
Visual and Tactile Scanning Training in Patients With Neglect After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HES-SO Valais-Wallis
Collaborators
University of Applied Sciences of Western Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
In patients with stroke, unilateral neglect is a predictor for poor independency and quality of life. Current therapies are lacking a progression of intensity based on clear criteria. In addition, therapies include rather analytical exercises and the transfer of the achieved functions to activities of daily living remains difficult. Therefore, the investigators developed a criterion based system, in which the investigators are matching interventions to specific neglect related deficits and behaviour. The investigators plan a randomised controlled trial (stage 2 "development of concept trial") to evaluate whether an Experimental Group with 20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation or a Control Group with 20 Sessions of 30 minutes of a standard visual scanning programme results in larger improvements on the neglect behaviour during activities of daily life (Catherine Bergego Scale). Sixteen stroke patients with left side neglect (i.e. right brain lesions) will be recruited in an inpatient rehabilitations setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemispatial Neglect
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Visual and tactile scanning training
Arm Type
Experimental
Arm Description
20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation
Arm Title
Unimodal visual scanning training
Arm Type
Active Comparator
Arm Description
20 sessions of 30 minutes with traditional uni-modal visual scanning training
Intervention Type
Other
Intervention Name(s)
Visual and tactile scanning training
Intervention Description
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.
Visual or tactile scanning in the personal space
Visual or tactile scanning and trunk rotation in the peripersonal space
Visual scanning and trunk rotation in the extrapersonal space
Intervention Type
Other
Intervention Name(s)
Uni-modal visual scanning training
Intervention Description
20 sessions of 30 minutes with traditional uni-modal visual scanning training in the peripersonal space.
Primary Outcome Measure Information:
Title
Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale
Description
Measured with the Catherine Bergego Scale
Time Frame
up to 14 months
Title
Adherence rate of the patients to the treatment
Time Frame
up to 11 months
Secondary Outcome Measure Information:
Title
Visual neglect measured with the Behavioural Inattention Test (conventional subtest)
Description
Measured with the Behavioural Inattention Test (conventional subtest)
Time Frame
up to 14 months
Title
Severity of disability in a rehabilitation setting measured with the Functional Independence Measure
Description
Measured with the Functional Independence Measure
Time Frame
up to 11 months
Title
Personal neglect measured with the Vest Test
Description
Measured with the Vest Test
Time Frame
up to 14 months
Title
Mobility related disability easured with the Rivermead Mobility Index
Description
Measured with the Rivermead Mobility Index
Time Frame
up to 11 months
Title
Health related quality of life measured with the EQ-5D
Description
Measured with the EQ-5D
Time Frame
up to 14 months
Title
Length of stay in inpatient rehabilitation setting
Time Frame
up to 11 months
Title
Inclusion rate and refusal rate per week
Time Frame
up to 11 months
Title
Completeness of documents
Time Frame
up to 11 months
Title
Length of time of assessments
Time Frame
up to 11 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Sattelmayer, MSc, MA
Email
martin.sattelmayer@hevs.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Roger Hilfiker, MPTSc
Email
roger.hilfiker@hevs.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Sattelmayer, MSc, MA
Organizational Affiliation
HES-SO Valais-Wallis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berner Klinik Montana
City
Montana
State/Province
Valais
ZIP/Postal Code
3963
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Sattelmayer, MA, MSc
Email
martin.sattelmayer@hevs.ch
12. IPD Sharing Statement
Learn more about this trial
Visual and Tactile Scanning Training in Patients With Neglect After Stroke
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