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

NCT05967078 | Unknown

• 1 other identifier: 2022-00559
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

  Acceptance criteria for occurence of any device deficiencies encountered during study visits is set to \<10%.

  1 day

Secondary Outcomes (3)

• Usability: Player Experience

  1 day

• Usability: System Usability

  1 day

• Perceived physical and mental exertion/ effort

  1 day

Study Arms (1)

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.

Device: ExerG

Interventions

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.

Also known as: ExerG training software licence

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Frank Behrendt: lead
• Innosuisse - Swiss Innovation Agency: collaborator

Study Sites (1)

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic; Conversion Disorder; Vision Disorders; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Somatoform Disorders; Mental Disorders; Sensation Disorders; Eye Diseases; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Frank Behrendt, PhD

  Reha Rheinfelden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: August 1, 2023
• Study Start: May 16, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 31, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)