Visual and Tactile Scanning Training in Patients With Neglect After Stroke (ViTaTrain)

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.

Study Overview

• Status: Unknown
• Conditions: Hemispatial Neglect
• Intervention / Treatment: Other: Visual and tactile scanning training; Other: Uni-modal visual scanning training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Valais
    • Montana, Valais, Switzerland, 3963
      • Recruiting
      • Berner Klinik Montana
      • Contact: Martin Sattelmayer, MA, MSc; Email: martin.sattelmayer@hevs.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visual and tactile scanning training; 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; 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
Active Comparator: Unimodal visual scanning training; 20 sessions of 30 minutes with traditional uni-modal visual scanning training	Other: Uni-modal visual scanning training; 20 sessions of 30 minutes with traditional uni-modal visual scanning training in the peripersonal space.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HES-SO Valais-Wallis
• Collaborators: University of Applied Sciences of Western Switzerland
• Investigators: Principal Investigator: Martin Sattelmayer, MSc, MA, HES-SO Valais-Wallis

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: November 9, 2014
• First Submitted That Met QC Criteria: December 4, 2014
• First Posted (Estimate): December 5, 2014

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders
• Other Study ID Numbers: P40907