Visual and Tactile Scanning Training in Patients With Neglect After Stroke

Hemispatial Neglect Clinical Trial

— ViTaTrain  

Official title:

Visual and Tactile Scanning Training in Patients With Neglect After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02309853
• Other study ID #: P40907
• Status: Recruiting
• Phase: N/A
• First received: November 9, 2014
• Last updated: December 4, 2014
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: HES-SO Valais-Wallis
• Contact: Martin Sattelmayer, MSc, MA
• Email: martin.sattelmayer[@]hevs.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemispatial Neglect

Intervention

Other:
• Visual and tactile scanning training
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
• Uni-modal visual scanning training
20 sessions of 30 minutes with traditional uni-modal visual scanning training in the peripersonal space.

Locations

Country	Name	City	State
Switzerland	Berner Klinik Montana	Montana	Valais

Sponsors (2)

Lead Sponsor	Collaborator
HES-SO Valais-Wallis	University of Applied Sciences of Western Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale	Measured with the Catherine Bergego Scale	up to 14 months	No
Primary	Adherence rate of the patients to the treatment		up to 11 months	No
Secondary	Visual neglect measured with the Behavioural Inattention Test (conventional subtest)	Measured with the Behavioural Inattention Test (conventional subtest)	up to 14 months	No
Secondary	Severity of disability in a rehabilitation setting measured with the Functional Independence Measure	Measured with the Functional Independence Measure	up to 11 months	No
Secondary	Personal neglect measured with the Vest Test	Measured with the Vest Test	up to 14 months	No
Secondary	Mobility related disability easured with the Rivermead Mobility Index	Measured with the Rivermead Mobility Index	up to 11 months	No
Secondary	Health related quality of life measured with the EQ-5D	Measured with the EQ-5D	up to 14 months	No
Secondary	Length of stay in inpatient rehabilitation setting		up to 11 months	No
Secondary	Inclusion rate and refusal rate per week		up to 11 months	No
Secondary	Completeness of documents		up to 11 months	No
Secondary	Length of time of assessments		up to 11 months	No