Clinical trial NCT05967078: ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study
Official title: ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gait Disorders, Neurologic
Gait Disorders in Old Age
Gait Disorder, Sensorimotor
Balance; Distorted
Functional Movement Disorder
Visual Disorder
Cognitive Impairment
Lead sponsor: Reha Rheinfelden
Sponsor class: OTHER
Collaborators: name: Innosuisse - Swiss Innovation Agency
First posted: 2023-08-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

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)

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

Exclusion Criteria:

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)
* 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)

Primary outcomes:
measure: Usability: performance rate
timeFrame: 1 day
measure: Usability: Number of participants with no need for support
timeFrame: 1 day
measure: Usability: exercise execution
timeFrame: 1 day
measure: Usability: Number of (serious) adverse events
timeFrame: 1 day
measure: Usability: device deficiencies
timeFrame: 1 day
Secondary outcomes:
measure: Usability: Player Experience
timeFrame: 1 day
measure: Usability: System Usability
timeFrame: 1 day
measure: Perceived physical and mental exertion/ effort
timeFrame: 1 day
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
state: Aargau
Study officials:
affiliation: Reha Rheinfelden
name: Frank Behrendt, PhD
role: PRINCIPAL_INVESTIGATOR
References: