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| Name | Class |
|---|---|
| Innosuisse - Swiss Innovation Agency | OTHER |
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Video game-based training programs, in the following referred to as "exergames" are an innovative digital training approach to simultaneously train physical and cognitive functions and increase training motivation for various populations. Patients who are differently limited in their physical and cognitive performance due to a decline in functioning can profit from a motivating and combined physical-cognitive training approach. An interdisciplinary team of movement scientists, sports and training experts, as well as game and industrial designers developed an innovative and immersive video game-based training product for patients - the ExerCube training software licence. The exergame development focused on a user-centred process together with the target population.
The ExerCube training software licence is an exergame training product that includes immersive mixed-reality training programs (or video games) for patients. Depending on the patient's training requirements, the therapists can choose from the training program repertoire. The patients control the training program (or video game) by specific (whole) body movements. To present the virtual training programs from the ExerCube training software licence in the physical environment, the ExerCube hardware and harness system is used to serve as a physical training room. It allows the virtual video game environment to be presented in the physical world.
This summative usability study aims to assess the training system's safety, usability and validate the user experience.
Primary end-users (defined as patients aged 18 and above) and secondary end-users (defined as sports scientists, training therapists or physiotherapists/occupational therapists with a focus on sports/training therapy) will test and review the system in different testing scenarios.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test group | Experimental | The device under investigation is the ExerCube training software licence provided by Sphery (https://sphery.ch/exercube/). The ExerCube training software licence is an exergame training product that includes immersive mixed-reality training programs (or video games) for patients. Depending on the patient's training requirements, the therapists can choose from the training program repertoire. The ExerCube supporting material for safety consisting of a harness and an over-head gantry system ensures a safe training environment and prevents patients from falling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ExerG | Device | The intervention for primary end users (PEU, (patients)) includes the performance of two training rounds with the device. The first round includes a predefined training sequence, whereas the second round is a training sequence defined by the therapist. For the secondary end user group (SEU, (therapists)), there are two study visits. At their first visit they get an introduction and training on how to use the system. At their second visit, SEU will have to prepare the device (switch on hard- and software) and guide the patient through the training. |
| Measure | Description | Time Frame |
|---|---|---|
| Usability: performance rate | The acceptance of the device is rated based on the observation protocol that is completed by the study moderator during the training session. Each participant will have a list of tasks to be completed per session/ training round. Primary end users (PEU): acceptance criteria for performance = correct task performance "yes" ≥ 85%, skipped tasks < 20% Secondary end users (SEU): acceptance criteria for performance = task performed correctly or with hesitant behaviour ≥ 85%, task not performed or with difficulties and failures < 15% | 1 day |
| Usability: Number of participants with no need for support | The acceptance of the device is rated based on the observation protocol that is completed by the study moderator during the training session. Each participant will have a list of tasks to be completed per session/ training round. Primary end users (PEU): acceptance criteria for comprehensibility = very good or good comprehension about how to perform the task ≥ 85% Secondary end users (SEU): acceptance criteria for support = task performed without support ≥ 85%, support needed to be able to complete the task < 15% | 1 day |
| Usability: exercise execution | The acceptance of the device is rated based on the observation protocol that is completed by the study moderator during the training session. Each participant will have a list of tasks to be completed per session/ training round. Primary end users (PEU): - acceptance criteria for exercise execution = very good or good exercise/ movement execution ≥ 85% | 1 day |
| Usability: Number of (serious) adverse events | (Serious) Adverse Events: acceptance criteria of occurrence of related adverse events should not exceed 10%. | 1 day |
| Usability: device deficiencies |
| Measure | Description | Time Frame |
|---|---|---|
| Usability: Player Experience | Primary end users (PEUs): The user experience will be assessed with the Player Experience Inventory (PXI), a 30 item questionnaire containing 10 different constructs to measure different aspects of player experience (three items per construct). All items are rated on a 7-point Likert scale (scale range: -3 to 3 points, maximal score = +90; minimal score: -90). | 1 day |
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Inclusion Criteria:
Primary end users:
Secondary end users:
Exclusion Criteria:
Primary end users
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Behrendt, PhD | Contact | +41 61 836 5387 | f.behrendt@reha-rhf.ch | |
| Silvia Herren, MSc | Contact | +41 61 836 5388 | s.herren@reha-rhf.ch |
| Name | Affiliation | Role |
|---|---|---|
| Frank Behrendt, PhD | Reha Rheinfelden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reha Rheinfelden | Recruiting | Rheinfelden | Canton of Aargau | 4310 | Switzerland |
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Acceptance criteria for occurence of any device deficiencies encountered during study visits is set to <10%.
| 1 day |
| Usability: System Usability | Secondary end users (SEUs): The System Usability Scale (SUS) will be completed by secondary end users to evaluate the perceived usability. SUS assesses perceived effectiveness (can users successfully achieve their objectives), information quality (how much effort and resource is expended in achieving those objectives) and general satisfaction (was the experience satisfactory). The SUS hast 10 items that can be rated on a 5-point likert scale. The items will be scored as follows:
| 1 day |
| Perceived physical and mental exertion/ effort | Perceived physical exertion during the training will be assessed with the Borg-category rating 10 (Borg CR10; scale range from 0= no exertion at all, 10= maximal level of exertion). Perceived mental effort will be assessed from primary end users with the Paas mental effort scale (Paas, 1992) ranging from 1= very, very low mental effort, 9=very, very high mental effort. | 1 day |
| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| D003291 | Conversion Disorder |
| D014786 | Vision Disorders |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
| D012678 | Sensation Disorders |
| D005128 | Eye Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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