ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study

NCT ID: NCT05967078

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-16
• Study Completion Date: 2023-10-31

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.

Conditions

Gait Disorders, Neurologic; Gait Disorders in Old Age; Gait Disorder, Sensorimotor; Balance; Distorted; Functional Movement Disorder; Visual Disorder; Cognitive Impairment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Test group

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.

Group Type: EXPERIMENTAL

ExerG

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

ExerG training software licence

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innosuisse - Swiss Innovation Agency

OTHER

Sponsor Role: collaborator

Frank Behrendt

OTHER

Sponsor Role: lead

Responsible Party

Frank Behrendt

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Frank Behrendt, PhD

Role: PRINCIPAL_INVESTIGATOR

Reha Rheinfelden

Locations

Reha Rheinfelden

Rheinfelden, Canton of Aargau, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Frank Behrendt, PhD

Role: CONTACT

f.behrendt@reha-rhf.ch

+41 61 836 5387

Silvia Herren, MSc

Role: CONTACT

s.herren@reha-rhf.ch

+41 61 836 5388

Facility Contacts

Silvia Herren

Role: primary

s.herren@reha-rhf.ch

+41 61 836 5388

Other Identifiers

2022-00559

Identifier Type: -

Identifier Source: org_study_id