Gait Disorders, NeurologicExerGeticNCT05967078
ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study
A study testing ExerG in people with Gait Disorders, Neurologic and Gait Disorders in Old Age, run by Frank Behrendt at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gait Disorders, Neurologic, Gait Disorders in Old Age, Gait Disorder, Sensorimotor
- What is being tested?
- ExerG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 May 2023to 31 Oct 2023
- 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
- Primary end users:
- in-/ or outpatients of the Reha Rheinfelden
- Ability to speak and comprehend German and to understand the digitally transmitted training instructions
- Body height ≥ 160 cm or ≤ 200 cm according to hardware specifications
- Body weight ≤ 120 kg
- Able to execute the movements of the video game-based training (being able to transfer from a sitting to a standing position and maintain the standing position without assistance for ≥ 2 minutes)
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- Secondary end users:
- therapists (physiotherapist, occupational therapist, sport scientist, sport therapist, psychologists) working in the area of rehabilitation and prevention
- ≥ 21 years of age
- Bachelor's degree (scientists) or completed education as therapist
Who cannot join
- Primary end users
- Cognitive impairment as defined by a Mini Mental State Examination (MMSE) score of ≤ 18
- Severe visual, neurological, cardiorespiratory, psychiatric, or orthopedic impairments which reduce the person's capability of following the instructions or to play the game
- Recently occurred epileptic seizures (in the past 3 months)
- Recent surgery/fractures/surgical interventions/joint replacement and malignancy (in the past 3 months)
- Physical conditions in which a correct wearing of the Safety harness is not possible or could cause pain or health problems (e.g. skin lesions, open wounds, known pregnancy, severe osteoporosis)
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- Joint contractures (e.g. shoulder, knee, hip) that could lead to limitations during end-user evaluation of the ExerCube.
- Severe neurologic illness (e.g., strong epilepsy, advanced parkinson's syndrome, condition after severe stroke)
- Severe psychiatric illness (e.g., pronounced paranoid states, severe depression)
- Terminal illness (prognosis < 12 months)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Reha Rheinfelden
Rheinfelden, Canton of Aargau, 4310
Silvia Herren, +41 61 836 5388, s.herren@reha-rhf.ch
About this study
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.
Read more
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.
- Conditions
- Gait Disorders, Neurologic, Gait Disorders in Old Age, Gait Disorder, Sensorimotor, Balance; Distorted, Functional Movement Disorder, Visual Disorder
- Being tested
- ExerG
- Medical subject headings
- Gait Disorders, Neurologic, Conversion Disorder, Vision Disorders, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerGDevice
Also called ExerG training software licence
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ExerG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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%
Measured: 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%
Measured: 1 day
Usability: Number of (serious) adverse events
(Serious) Adverse Events: acceptance criteria of occurrence of related adverse events should not exceed 10%.
Measured: 1 day
Usability: device deficiencies
Acceptance criteria for occurence of any device deficiencies encountered during study visits is set to <10%.
Measured: 1 day
Secondary outcomes (3)
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).
Measured: 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:
- 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
- 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)
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start16 May 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait Disorders, NeurologicStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Frank Behrendt
- Sponsor type
- University, hospital or other
- Collaborators
- Innosuisse - Swiss Innovation Agency
- Responsible party
- Sponsor-investigator, Frank Behrendt, Reha Rheinfelden
- Investigators
- Frank Behrendt, PhD, Principal investigator, Reha Rheinfelden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05967078
- Sponsor's protocol ID
- 2022-00559
- Acronym
- ExerGetic
- Status last verified
- Jul 2023
- First submitted
- 19 Jun 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study
- ClinicalTrials.gov ID
- NCT05967078
- Acronym / sponsor ID
- ExerGetic / 2022-00559
- Conditions
- Gait Disorders, Neurologic, Gait Disorders in Old Age, Gait Disorder, Sensorimotor, Balance; Distorted, Functional Movement Disorder, Visual Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Frank BehrendtUniversity, hospital or other
- Collaborators
- Innosuisse - Swiss Innovation Agency
- Study start
- 16 May 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 1 Aug 2023 (actual)
- 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: ExerGThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- in-/ or outpatients of the Reha Rheinfelden
- Ability to speak and comprehend German and to understand the digitally transmitted training instructions
- Body height ≥ 160 cm or ≤ 200 cm according to hardware specifications
- Body weight ≤ 120 kg
- Able to execute the movements of the video game-based training (being able to transfer from a sitting to a standing position and maintain the standing position without assistance for ≥ 2 minutes)
Key exclusion criteria (10 listed)
- Primary end users
- Cognitive impairment as defined by a Mini Mental State Examination (MMSE) score of ≤ 18
- Severe visual, neurological, cardiorespiratory, psychiatric, or orthopedic impairments which reduce the person's capability of following the instructions or to play the game
- Recently occurred epileptic seizures (in the past 3 months)
- Recent surgery/fractures/surgical interventions/joint replacement and malignancy (in the past 3 months)
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 |
|---|---|---|
| ExerGAlso: ExerG training software licenceThe 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. | Device | Test group |
Primary outcome
Usability: performance rate
Time frame: 1 day
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%
Usability: Number of participants with no need for support
Time frame: 1 day
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%
Usability: exercise execution
Time frame: 1 day
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%
Usability: Number of (serious) adverse events
Time frame: 1 day
(Serious) Adverse Events: acceptance criteria of occurrence of related adverse events should not exceed 10%.
Usability: device deficiencies
Time frame: 1 day
Acceptance criteria for occurence of any device deficiencies encountered during study visits is set to <10%.
3 secondary outcomes
Usability: Player Experience
Time frame: 1 day
Usability: System Usability
Time frame: 1 day
Perceived physical and mental exertion/ effort
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Frank Behrendt, PhD principal investigator
Reha Rheinfelden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExerG in people with Gait Disorders, Neurologic and Gait Disorders in Old Age, run by Frank Behrendt 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 10 inclusion and 10 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 1 Aug 2023. 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 Frank Behrendt, PhD (+41 61 836 5387, f.behrendt@reha-rhf.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability: performance rate (time frame: 1 day). The study lists 5 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 1 Aug 2023.