Visual and Tactile Scanning Training in Patients With Neglect After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Visual and Tactile Scanning Training in Patients With Neglect After Stroke

Conditions
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Hemispatial Neglect

Intervention / Treatment
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* Other: Visual and tactile scanning training
* Other: Uni-modal visual scanning training


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visual and tactile scanning training<br>20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation | Other: Visual and tactile scanning training<br>* 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<br>|
| Active Comparator: Unimodal visual scanning training<br>20 sessions of 30 minutes with traditional uni-modal visual scanning training | Other: Uni-modal visual scanning training<br>* 20 sessions of 30 minutes with traditional uni-modal visual scanning training in the peripersonal space.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual neglect measured with the Behavioural Inattention Test (conventional subtest) | 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 | Measured with the Functional Independence Measure | up to 11 months | 
| Personal neglect measured with the Vest Test | Measured with the Vest Test | up to 14 months | 
| Mobility related disability easured with the Rivermead Mobility Index | Measured with the Rivermead Mobility Index | up to 11 months | 
| Health related quality of life measured with the EQ-5D | Measured with the EQ-5D | up to 14 months | 
| Length of stay in inpatient rehabilitation setting |  | up to 11 months | 
| Inclusion rate and refusal rate per week |  | up to 11 months | 
| Completeness of documents |  | up to 11 months | 
| Length of time of assessments |  | up to 11 months |