Hemispatial NeglectViTaTrainNCT02309853
Visual and Tactile Scanning Training in Patients With Neglect After Stroke
A study testing Visual and tactile scanning training and Uni-modal visual scanning training in people with Hemispatial Neglect, run by HES-SO Valais-Wallis at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemispatial Neglect
- What is being tested?
- Visual and tactile scanning training and Uni-modal visual scanning training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Martin Sattelmayer, MSc, MA contact
Roger Hilfiker, MPTSc contact
Switzerland1 site, 1 recruiting
- Recruiting
Berner Klinik Montana
Montana, Valais, 3963
Martin Sattelmayer, MA, MSc, martin.sattelmayer@hevs.ch
About this study
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.
Read the 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.
- Conditions
- Hemispatial Neglect
- Being tested
- Visual and tactile scanning training, Uni-modal visual scanning training
- Medical subject headings
- Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual and tactile scanning trainingOther
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 trainingOther
20 sessions of 30 minutes with traditional uni-modal visual scanning training in the peripersonal space.
| Study group | Role | What they receive |
|---|---|---|
| Visual and tactile scanning training | Experimental | 20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation Receives: Other: Visual and tactile scanning training |
| Unimodal visual scanning training | Active comparator | 20 sessions of 30 minutes with traditional uni-modal visual scanning training Receives: Other: Uni-modal visual scanning training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale
Measured with the Catherine Bergego Scale
Measured: up to 14 months
Adherence rate of the patients to the treatment
Measured: up to 11 months
Secondary outcomes (9)
Visual neglect measured with the Behavioural Inattention Test (conventional subtest)
Measured with the Behavioural Inattention Test (conventional subtest)
Measured: up to 14 months
Severity of disability in a rehabilitation setting measured with the Functional Independence Measure
Measured with the Functional Independence Measure
Measured: up to 11 months
Personal neglect measured with the Vest Test
Measured with the Vest Test
Measured: up to 14 months
Mobility related disability easured with the Rivermead Mobility Index
Measured with the Rivermead Mobility Index
Measured: up to 11 months
Health related quality of life measured with the EQ-5D
Measured with the EQ-5D
Measured: up to 14 months
Length of stay in inpatient rehabilitation setting
Measured: up to 11 months
Inclusion rate and refusal rate per week
Measured: up to 11 months
Completeness of documents
Measured: up to 11 months
Length of time of assessments
Measured: up to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemispatial NeglectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HES-SO Valais-Wallis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland
- Responsible party
- Sponsor
- Investigators
- Martin Sattelmayer, MSc, MA, Principal investigator, HES-SO Valais-Wallis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309853
- Sponsor's protocol ID
- P40907
- Acronym
- ViTaTrain
- Status last verified
- Dec 2014
- First submitted
- 9 Nov 2014
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual and Tactile Scanning Training in Patients With Neglect After Stroke
- ClinicalTrials.gov ID
- NCT02309853
- Acronym / sponsor ID
- ViTaTrain / P40907
- Conditions
- Hemispatial Neglect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- HES-SO Valais-WallisUniversity, hospital or other
- Collaborators
- University of Applied Sciences of Western Switzerland
- Study start
- Dec 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual and tactile scanning training | Experimental | Other: Visual and tactile scanning training20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation |
| Unimodal visual scanning training | Active comparator | Other: Uni-modal visual scanning training20 sessions of 30 minutes with traditional uni-modal visual scanning training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual and tactile scanning training20 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 | Other | Visual and tactile scanning training |
| Uni-modal visual scanning training20 sessions of 30 minutes with traditional uni-modal visual scanning training in the peripersonal space. | Other | Unimodal visual scanning training |
Primary outcome
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
Adherence rate of the patients to the treatment
Time frame: up to 11 months
9 secondary outcomes
Visual neglect measured with the Behavioural Inattention Test (conventional subtest)
Time frame: up to 14 months
Severity of disability in a rehabilitation setting measured with the Functional Independence Measure
Time frame: up to 11 months
Personal neglect measured with the Vest Test
Time frame: up to 14 months
Mobility related disability easured with the Rivermead Mobility Index
Time frame: up to 11 months
Health related quality of life measured with the EQ-5D
Time frame: up to 14 months
Length of stay in inpatient rehabilitation setting
Time frame: up to 11 months
Inclusion rate and refusal rate per week
Time frame: up to 11 months
Completeness of documents
Time frame: up to 11 months
Length of time of assessments
Time frame: up to 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Sattelmayer, MSc, MA contact
Roger Hilfiker, MPTSc contact
Martin Sattelmayer, MSc, MA principal investigator
HES-SO Valais-Wallis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual and tactile scanning training and Uni-modal visual scanning training in people with Hemispatial Neglect, run by HES-SO Valais-Wallis at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Sattelmayer, MSc, MA (martin.sattelmayer@hevs.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale (time frame: up to 14 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.