Clinical trial NCT02309853: Visual and Tactile Scanning Training in Patients With Neglect After Stroke
Official title: Visual and Tactile Scanning Training in Patients With Neglect After Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemispatial Neglect
Lead sponsor: HES-SO Valais-Wallis
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences of Western Switzerland
First posted: 2014-12-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale
timeFrame: up to 14 months
measure: Adherence rate of the patients to the treatment
timeFrame: up to 11 months
Secondary outcomes:
measure: Visual neglect measured with the Behavioural Inattention Test (conventional subtest)
timeFrame: up to 14 months
measure: Severity of disability in a rehabilitation setting measured with the Functional Independence Measure
timeFrame: up to 11 months
measure: Personal neglect measured with the Vest Test
timeFrame: up to 14 months
measure: Mobility related disability easured with the Rivermead Mobility Index
timeFrame: up to 11 months
measure: Health related quality of life measured with the EQ-5D
timeFrame: up to 14 months
measure: Length of stay in inpatient rehabilitation setting
timeFrame: up to 11 months
measure: Inclusion rate and refusal rate per week
timeFrame: up to 11 months
measure: Completeness of documents
timeFrame: up to 11 months
measure: Length of time of assessments
timeFrame: up to 11 months
Other outcomes:
Locations:
city: Montana
country: Switzerland
facility: Berner Klinik Montana
state: Valais
Study officials:
affiliation: HES-SO Valais-Wallis
name: Martin Sattelmayer, MSc, MA
role: PRINCIPAL_INVESTIGATOR
References: