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

December 4, 2014 updated by: HES-SO Valais-Wallis
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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

  1. Visual or tactile scanning in the personal space
  2. Visual or tactile scanning and trunk rotation in the peripersonal space
  3. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale
Time Frame: up to 14 months
Measured with the Catherine Bergego Scale
up to 14 months
Adherence rate of the patients to the treatment
Time Frame: up to 11 months
up to 11 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual neglect measured with the Behavioural Inattention Test (conventional subtest)
Time Frame: up to 14 months
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
Time Frame: up to 11 months
Measured with the Functional Independence Measure
up to 11 months
Personal neglect measured with the Vest Test
Time Frame: up to 14 months
Measured with the Vest Test
up to 14 months
Mobility related disability easured with the Rivermead Mobility Index
Time Frame: up to 11 months
Measured with the Rivermead Mobility Index
up to 11 months
Health related quality of life measured with the EQ-5D
Time Frame: up to 14 months
Measured with the EQ-5D
up to 14 months
Length of stay in inpatient rehabilitation setting
Time Frame: up to 11 months
up to 11 months
Inclusion rate and refusal rate per week
Time Frame: up to 11 months
up to 11 months
Completeness of documents
Time Frame: up to 11 months
up to 11 months
Length of time of assessments
Time Frame: up to 11 months
up to 11 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HES-SO Valais-Wallis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Applied Sciences of Western Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin Sattelmayer, MSc, MA, HES-SO Valais-Wallis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P40907

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemispatial Neglect

Clinical Trials on Visual and tactile scanning training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings