Hemispatial NeglectNCT02353962
Evaluating the Feasibility and Usability of Exergames in Stroke Patients With Visuo-spatial Neglect
A study testing Neglect Exergames in people with Hemispatial Neglect, run by University of Zurich at 2 sites in Switzerland.
Trial summary
The aim of this study is to evaluate the feasibility and usability of newly developed exergames on exploring the hemineglected space of left neglected stroke patients. Furthermore to understand the experience of living with visuospatial neglect and to explore the users' experiences (patients and clinic staff) with… 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?
- Neglect Exergames
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Mar 2015to Feb 2017
- 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
- Patients with visuo-spatial neglect on the left side resulting from a right hemisphere lesion due to a stroke (as measured by the Catherine Bergego Scale (CBS)
- Stroke incident between 15 to 180 days at the time point of study inclusion
- In possession of power of judgement regarding to the participation in the study
- Ability to sit in a (wheel-)chair with a backrest for 45 minutes maximum
- Age ≥18 years
Who cannot join
- Diagnosis of a brain injury other than stroke
- Other visuospatial syndromes than neglect (e.g. hemianopsia, Balint-syndrome)
- Occurrence of severe apraxia (˂ 5 points on the Apraxia Screening Tool of TULIA (AST)) (that makes the use of the platform impossible, e.g. not knowing how to use the Novint Falcon haptic device)
- Non-controlled medical conditions (chronic pain, drug abuse)
- Poor vision (that makes the use of the platform impossible, e.g. not being able to see clearly on a distance of 60-65cm (placement of PC screen))
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Klinik Bethesda
Tschugg, Canton of Bern, 3233
Zürcher Höhenklinik Wald
Wald, Canton of Zurich, 8639
About this study
Official title: Evaluating the Feasibility and Usability of Exergames on Exploring the Hemineglected Space in Stroke Patients With Visuo-spatial Neglect
The aim of this study is to evaluate the feasibility and usability of newly developed exergames on exploring the hemineglected space of left neglected stroke patients. Furthermore to understand the experience of living with visuospatial neglect and to explore the users' experiences (patients and clinic staff) with those new exergames.
Read the detailed description
Within the REWIRE project, nine exergames have been developed for the treatment of visuospatial neglect after stroke. All the exercises were aimed, according to classical rehabilitation, to drive the patients towards the exploration of the hemi-neglected space. The Gentile's taxonomy has been extended to neglect patients and was used to develop the exergames. Gentile's taxonomy of motor skills allows a simple to complex progression of skills and enables determining progress on an objective basis.
According to these specifications, the exergames targeting the exploration of space with additional cognitive and memory tasks with increasing difficulty levels have been developed. This allows an individual game selection suitable for the neglect patient's cognitive skills and guarantees a constant learning process.
The assessments and the virtual-reality based neglect training intervention for the stroke patients will take place at the collaborating rehabilitation clinics in Switzerland.
The neglect training is thought to be an additional therapy option to regain functional independence together with the standard rehabilitation program patients are following during their inpatient stay at the clinic. The exergame neglect training intervention is based on the widely accepted motor learning training principles specificity, initial values, overload and progression. Furthermore, the intervention is planned according to the FITT components; these are: Frequency, Intensity, Time and Type of training. The intervention is characterized by the following parameters:
- Frequency: 5 sessions per week
- Intensity: individually adjusted by the treating therapist according to the progress of the participating patient
- Time: 30-45 minutes per training for 3 weeks
- Type: REWIRE neglect exergames
The assessments:
Assessing cognition: Zürcher Maxi Mental Status Test (ZüMAX) The ZüMAX is a test performed in an interview situation to get a quick (about 30 min) first assessment of neuropsychological deficits but suits also for long term controlling. It provides a reliable index of the following domains: language, praxia, learning and memory, perception and visual-constructive abilities as well as of executive functions. In each of these five functional domains, a maximum of 6 points can be scored; obviously, a total of 30 points represents optimal functioning. In addition to this numerical scoring, the ZüMAX allows also the qualitative judgment of an individual's alertness, ability to cooperate, tempo and emotion. The necessary equipment for the ZüMAX is the following: stopwatch, metronome, pencil for patients (no ruler, no eraser), 24 stimulus cards (chimerical faces), ZüMAX testing form with one coversheet, seven demonstration sheets, four work sheets and four record sheets. Its test-retest-reliability and concurrent validity have recently been examined for the stroke population.
Assessing eye movements: The Eye Tribe Tracker (TETT) To get a better estimate if the games really influence the exploration of the hemi-neglected space, the eye movements will be tracked by "THE EYE TRIBE TRACKER" (TETT). It was developed by the Copenhagen-based eye-tracking start-up company, The Eye Tribe. The company is the first in its category to offer reliable, consumer-grade eye tracking products. The Eye Tribe tracker is a brand new sensor combined with an infrared illumination system that provides the very best conditions for the eye tracking algorithms to work with. The high resolution sensor ensures that the tiny movements of the pupils can be tracked with high precision while maintaining a wide field of view. The advanced algorithms work in tandem with the hardware to optimize for most environments and light conditions. However, it works best in indoor scenarios without direct sunlight on the device. Its operating range is from 45cm to 75cm, and the tracking area is 40cm x 30cm at 65cm distance (30Hz). The participant will perform an adapted version (using their eyes instead of their finger) of the test developed by Rabuffetti et al. This Neglect test consists of a uniform distribution of 120 stimuli, either letters or shapes, including 40 targets and 80 distracters. Each participant will be seated in front of the screen with the mid-sagittal plane of the trunk aligned with the center of the screen. The task consists of looking (instead of touching with the index finger) at all the targets that the subject will be able to detect. Once the target will be looked at for approximately 2 seconds, it will be circled.
In order to avoid compensatory movements of the head, a chin rest (will be located at the table in front of the patient. This model is individually adjustable to the height of the patient, produced out of hygienic materials (varnished wood, aluminium, polyester tissue) and regularly used by opticians for vision training. The chin rest will also be used during the intervention while playing the exergames.
Assessing visuospatial neglect: Behavioral Inattention Test (BIT, German: NET) The standardized BIT consists of six conventional subtests (similar to the cancellation, bisection, and copying measures) and nine behavioral subtests designed to identify a wide variety of visual neglect behaviors. The conventional subtests are as follows: Letter and Star Cancellation , Figure and Shape Copying, Line Crossing and Bisection and Representational Drawing.
The nine behavioral subtests of the instrument all assess aspects of daily life: Picture Scanning with three pictures (plate of food, bathroom sink, and a room), Telephone Dialing, Menu Reading; Article Reading, Telling and Setting Time, Coin Sorting, Address and Sentence Copying, Map Navigation, and Card Sorting. Each subtest receives a maximum of 9 points, so the maximum total score is 81. Scores can provide a functional profile of neglect and a meaningful guide for treatment.
The BIT has been shown to be a robust predictor of visuospatial neglect and is a predictor of functionality after stroke. It quantifies neglect through offering an established concrete cutoff for detection of visuospatial neglect (BIT < 130). Inter-rater, parallel form, and test-retest reliability are high (r = .99, .91, .99, respectively, p < .001). Concurrent validity was established by examining the relationship between the conventional and behavioral test scores (r = .92, P < .001). There exists a validated German version of the BIT, called NET (Neglect-Test) which will be used for this study project.
The ZüMAX and the NET will be repeated after 3 weeks training intervention and furthermore 4 weeks after the training intervention as follow up.
As follow up the investigator assessing personal experiences of neglect patients with individual interviews.To describe and understand how persons with visuo-spatial neglect experience and discover their disabilities in daily life during rehabilitation, the investigator therefore has chosen to adopt a transcendental or psychological phenomenological research design. A phenomenological study describes the meaning for several individuals of their lived experiences of a phenomenon - in this project: visuo-spatial neglect. These experiences are best assessed in individual interviews. To find out if the experience of playing the neglect exergames supported them in learning to handle their disabilities, open-ended interview questions addressing this topic are included in the interview guide. The interview will take place during the same week as the follow-up measurements at a place convenient for the participant.
Meanwhile the investigator is assessing also the personal experiences of the clinic staff involved in the neglect exergame training with a focus group interview. In order to deepen the collected answers from the questionnaire given by the clinic staff involved in the study, the examiner will organize a focus-group interview after termination of the neglect exergame training intervention. The beforehand evaluated "clinic staff questionnaires" will serve as a basis for discussion.
- Conditions
- Hemispatial Neglect
- Being tested
- Neglect Exergames
- Keywords
- neglect, exergames
- Medical subject headings
- Perceptual Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neglect ExergamesOther
Exergames for rehabilitation of hemineglected stroke patients played with a haptic device on a computer. The intervention duration is three weeks. During this week the patients play daily a half hour on workdays. The treatening therapist will adjust the intensity according to the progress of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Neglect Exergames | Experimental | Exergames for rehabilitation of hemineglected stroke patients played with a haptic device on a computer. 5 sessions per week, 30-45 minutes per training for 3 weeks, with an intensity individually adjusted by the treating therapist according to the progress of the participating patient. Receives: Other: Neglect Exergames |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of exergames as measured by training diary.
During the intervention (3 weeks).
Measured: 3 weeks
Secondary outcomes (3)
Usability of exergames as measured by questionnaire.
Questionnaire: After termination of the intervention (3 weeks)
Measured: 7-8 weeks
Understanding the experience of living with visuospatial neglect as measured by interviews.
Interview: 4 weeks after termination of the intervention (3 weeks) during follow-up.
Measured: 7-8 weeks
Collecting preliminary data for efficacy as measured by the ZüMAX, the NET and the Eye Tribe Tracker.
Pre-, post- and 4 weeks after training intervention (3 weeks).
Measured: 7-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemispatial NeglectStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rudolf Knols, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02353962
- Sponsor's protocol ID
- KEK-2014-0543
- Status last verified
- Feb 2017
- First submitted
- 21 Jan 2015
- Last updated
- 10 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Tobler-Ammann BC, Surer E, Knols RH, Borghese NA, de Bruin ED. User Perspectives on Exergames Designed to Explore the Hemineglected Space for Stroke Patients With Visuospatial Neglect: Usability Study. JMIR Serious Games. 2017 Aug 25;5(3):e18. doi: 10.2196/games.8013.
PubMed 28842390
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Usability of Exergames on Exploring the Hemineglected Space in Stroke Patients With Visuo-spatial Neglect
- ClinicalTrials.gov ID
- NCT02353962
- Acronym / sponsor ID
- KEK-2014-0543
- Conditions
- Hemispatial Neglect
- Keywords
- neglect, exergames
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 3 Feb 2015 (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 aim of this study is to evaluate the feasibility and usability of newly developed exergames on exploring the hemineglected space of left neglected stroke patients. Furthermore to understand the experience of living with visuospatial neglect and to explore the users' experiences (patients and clinic staff) with those new exergames.
Detailed description
Within the REWIRE project, nine exergames have been developed for the treatment of visuospatial neglect after stroke. All the exercises were aimed, according to classical rehabilitation, to drive the patients towards the exploration of the hemi-neglected space. The Gentile's taxonomy has been extended to neglect patients and was used to develop the exergames. Gentile's taxonomy of motor skills allows a simple to complex progression of skills and enables determining progress on an objective basis.
According to these specifications, the exergames targeting the exploration of space with additional cognitive and memory tasks with increasing difficulty levels have been developed. This allows an individual game selection suitable for the neglect patient's cognitive skills and guarantees a constant learning process.
The assessments and the virtual-reality based neglect training intervention for the stroke patients will take place at the collaborating rehabilitation clinics in Switzerland.
The neglect training is thought to be an additional therapy option to regain functional independence together with the standard rehabilitation program patients are following during their inpatient stay at the clinic. The exergame neglect training intervention is based on the widely accepted motor learning training principles specificity, initial values, overload and progression. Furthermore, the intervention is planned according to the FITT components; these are: Frequency, Intensity, Time and Type of training. The intervention is characterized by the following parameters:
- Frequency: 5 sessions per week
- Intensity: individually adjusted by the treating therapist according to the progress of the participating patient
- Time: 30-45 minutes per training for 3 weeks
- Type: REWIRE neglect exergames
The assessments:
Assessing cognition: Zürcher Maxi Mental Status Test (ZüMAX) The ZüMAX is a test performed in an interview situation to get a quick (about 30 min) first assessment of neuropsychological deficits but suits also for long term controlling. It provides a reliable index of the following domains: language, praxia, learning and memory, perception and visual-constructive abilities as well as of executive functions. In each of these five functional domains, a maximum of 6 points can be scored; obviously, a total of 30 points represents optimal functioning. In addition to this numerical scoring, the ZüMAX allows also the qualitative judgment of an individual's alertness, ability to cooperate, tempo and emotion. The necessary equipment for the ZüMAX is the following: stopwatch, metronome, pencil for patients (no ruler, no eraser), 24 stimulus cards (chimerical faces), ZüMAX testing form with one coversheet, seven demonstration sheets, four work sheets and four record sheets. Its test-retest-reliability and concurrent validity have recently been examined for the stroke population.
Assessing eye movements: The Eye Tribe Tracker (TETT) To get a better estimate if the games really influence the exploration of the hemi-neglected space, the eye movements will be tracked by "THE EYE TRIBE TRACKER" (TETT). It was developed by the Copenhagen-based eye-tracking start-up company, The Eye Tribe. The company is the first in its category to offer reliable, consumer-grade eye tracking products. The Eye Tribe tracker is a brand new sensor combined with an infrared illumination system that provides the very best conditions for the eye tracking algorithms to work with. The high resolution sensor ensures that the tiny movements of the pupils can be tracked with high precision while maintaining a wide field of view. The advanced algorithms work in tandem with the hardware to optimize for most environments and light conditions. However, it works best in indoor scenarios without direct sunlight on the device. Its operating range is from 45cm to 75cm, and the tracking area is 40cm x 30cm at 65cm distance (30Hz). The participant will perform an adapted version (using their eyes instead of their finger) of the test developed by Rabuffetti et al. This Neglect test consists of a uniform distribution of 120 stimuli, either letters or shapes, including 40 targets and 80 distracters. Each participant will be seated in front of the screen with the mid-sagittal plane of the trunk aligned with the center of the screen. The task consists of looking (instead of touching with the index finger) at all the targets that the subject will be able to detect. Once the target will be looked at for approximately 2 seconds, it will be circled.
In order to avoid compensatory movements of the head, a chin rest (will be located at the table in front of the patient. This model is individually adjustable to the height of the patient, produced out of hygienic materials (varnished wood, aluminium, polyester tissue) and regularly used by opticians for vision training. The chin rest will also be used during the intervention while playing the exergames.
Assessing visuospatial neglect: Behavioral Inattention Test (BIT, German: NET) The standardized BIT consists of six conventional subtests (similar to the cancellation, bisection, and copying measures) and nine behavioral subtests designed to identify a wide variety of visual neglect behaviors. The conventional subtests are as follows: Letter and Star Cancellation , Figure and Shape Copying, Line Crossing and Bisection and Representational Drawing.
The nine behavioral subtests of the instrument all assess aspects of daily life: Picture Scanning with three pictures (plate of food, bathroom sink, and a room), Telephone Dialing, Menu Reading; Article Reading, Telling and Setting Time, Coin Sorting, Address and Sentence Copying, Map Navigation, and Card Sorting. Each subtest receives a maximum of 9 points, so the maximum total score is 81. Scores can provide a functional profile of neglect and a meaningful guide for treatment.
The BIT has been shown to be a robust predictor of visuospatial neglect and is a predictor of functionality after stroke. It quantifies neglect through offering an established concrete cutoff for detection of visuospatial neglect (BIT < 130). Inter-rater, parallel form, and test-retest reliability are high (r = .99, .91, .99, respectively, p < .001). Concurrent validity was established by examining the relationship between the conventional and behavioral test scores (r = .92, P < .001). There exists a validated German version of the BIT, called NET (Neglect-Test) which will be used for this study project.
The ZüMAX and the NET will be repeated after 3 weeks training intervention and furthermore 4 weeks after the training intervention as follow up.
As follow up the investigator assessing personal experiences of neglect patients with individual interviews.To describe and understand how persons with visuo-spatial neglect experience and discover their disabilities in daily life during rehabilitation, the investigator therefore has chosen to adopt a transcendental or psychological phenomenological research design. A phenomenological study describes the meaning for several individuals of their lived experiences of a phenomenon - in this project: visuo-spatial neglect. These experiences are best assessed in individual interviews. To find out if the experience of playing the neglect exergames supported them in learning to handle their disabilities, open-ended interview questions addressing this topic are included in the interview guide. The interview will take place during the same week as the follow-up measurements at a place convenient for the participant.
Meanwhile the investigator is assessing also the personal experiences of the clinic staff involved in the neglect exergame training with a focus group interview. In order to deepen the collected answers from the questionnaire given by the clinic staff involved in the study, the examiner will organize a focus-group interview after termination of the neglect exergame training intervention. The beforehand evaluated "clinic staff questionnaires" will serve as a basis for discussion.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neglect Exergames | Experimental | Other: Neglect ExergamesExergames for rehabilitation of hemineglected stroke patients played with a haptic device on a computer. 5 sessions per week, 30-45 minutes per training for 3 weeks, with an intensity individually adjusted by the treating therapist according to the progress of the participating patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with visuo-spatial neglect on the left side resulting from a right hemisphere lesion due to a stroke (as measured by the Catherine Bergego Scale (CBS)
- Stroke incident between 15 to 180 days at the time point of study inclusion
- In possession of power of judgement regarding to the participation in the study
- Ability to sit in a (wheel-)chair with a backrest for 45 minutes maximum
- Age ≥18 years
Key exclusion criteria (5 listed)
- Diagnosis of a brain injury other than stroke
- Other visuospatial syndromes than neglect (e.g. hemianopsia, Balint-syndrome)
- Occurrence of severe apraxia (˂ 5 points on the Apraxia Screening Tool of TULIA (AST)) (that makes the use of the platform impossible, e.g. not knowing how to use the Novint Falcon haptic device)
- Non-controlled medical conditions (chronic pain, drug abuse)
- Poor vision (that makes the use of the platform impossible, e.g. not being able to see clearly on a distance of 60-65cm (placement of PC screen))
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 |
|---|---|---|
| Neglect ExergamesExergames for rehabilitation of hemineglected stroke patients played with a haptic device on a computer. The intervention duration is three weeks. During this week the patients play daily a half hour on workdays. The treatening therapist will adjust the intensity according to the progress of the patient. | Other | Neglect Exergames |
Primary outcome
Feasibility of exergames as measured by training diary.
Time frame: 3 weeks
During the intervention (3 weeks).
3 secondary outcomes
Usability of exergames as measured by questionnaire.
Time frame: 7-8 weeks
Understanding the experience of living with visuospatial neglect as measured by interviews.
Time frame: 7-8 weeks
Collecting preliminary data for efficacy as measured by the ZüMAX, the NET and the Eye Tribe Tracker.
Time frame: 7-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Derived from this study: PubMed 28842390Tobler-Ammann BC, Surer E, Knols RH, Borghese NA, de Bruin ED. User Perspectives on Exergames Designed to Explore the Hemineglected Space for Stroke Patients With Visuospatial Neglect: Usability Study. JMIR Serious Games. 2017 Aug 25;5(3):e18. doi: 10.2196/games.8013.
- Project of the exergamesLink provided by the sponsor.
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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.
Rudolf Knols, PhD principal investigator
University of Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neglect Exergames in people with Hemispatial Neglect, run by University of Zurich at 2 sites 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of exergames as measured by training diary. (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02353962, which also lists 1 linked publication.
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 10 Feb 2017.