An interventional study of ExerG in Gait Disorders, Neurologic, Gait Disorders in Old Age and Gait Disorder, Sensorimotor, sponsored by Frank Behrendt. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-01.
Sponsored by Frank Behrendt · Not applicable, Interventional, and Other
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.
346 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 261 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →This is the only study on the registry with Frank Behrendt as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Primary end users:
Secondary end users:
Exclusion Criteria:
Primary end users
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: ExerG
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.
Also known as: ExerG training software licence
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%
Time frame: 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%
Time frame: 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%
Time frame: 1 day
Usability: Number of (serious) adverse events
(Serious) Adverse Events: acceptance criteria of occurrence of related adverse events should not exceed 10%.
Time frame: 1 day
Usability: device deficiencies
Acceptance criteria for occurence of any device deficiencies encountered during study visits is set to \<10%.
Time frame: 1 day
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).
Time frame: 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. For odd-numbered items, user response-1. For even-numbered items 5-user response. This scales all values from 0 to 4 (with four being the most positive response). Ref: Jeff Sauro, measuring usability 2. Add up the converted responses for each user and multiply that total by 2.5 (to convert the range of possible values from 0 to 100 instead of from 0 to 40)
Time frame: 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.
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
Started May 2023 (actual). Primary completion is estimated for Sep 2023, 4 months after the start.
Of 184 non-industry interventional studies with no phase under Gait Disorders, Neurologic, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 4 months is below that.
Counting every sponsor, half of 197 studies reached it within 14 months; a quarter within 5 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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