Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating the Feasibility and Usability of Exergames in Stroke Patients With Visuo-spatial Neglect

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02353962
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief 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 those new exergames.

Condition or disease Intervention/treatment Phase
Hemispatial Neglect Other: Neglect Exergames Not Applicable

  Hide Detailed Description

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating the Feasibility and Usability of Exergames on Exploring the Hemineglected Space in Stroke Patients With Visuo-spatial Neglect
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Neglect Exergames
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.
Other: Neglect Exergames
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.




Primary Outcome Measures :
  1. Feasibility of exergames as measured by training diary. [ Time Frame: 3 weeks ]
    During the intervention (3 weeks).


Secondary Outcome Measures :
  1. Usability of exergames as measured by questionnaire. [ Time Frame: 7-8 weeks ]
    Questionnaire: After termination of the intervention (3 weeks)

  2. Understanding the experience of living with visuospatial neglect as measured by interviews. [ Time Frame: 7-8 weeks ]
    Interview: 4 weeks after termination of the intervention (3 weeks) during follow-up.

  3. Collecting preliminary data for efficacy as measured by the ZüMAX, the NET and the Eye Tribe Tracker. [ Time Frame: 7-8 weeks ]
    Pre-, post- and 4 weeks after training intervention (3 weeks).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353962


Locations
Layout table for location information
Switzerland
Klinik Bethesda
Tschugg, Berne, Switzerland, 3233
Zürcher Höhenklinik Wald
Wald, Zürich, Switzerland, 8639
Sponsors and Collaborators
University of Zurich
Investigators
Layout table for investigator information
Principal Investigator: Rudolf Knols, PhD University of Zurich

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02353962     History of Changes
Other Study ID Numbers: KEK-2014-0543
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Keywords provided by University of Zurich:
neglect
exergames
Additional relevant MeSH terms:
Layout table for MeSH terms
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms