ExerG: Video Game-based Physical Cognitive Training for Patients: a Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Usability: Number of (serious) adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Usability: Number of (serious) adverse events
时间窗: 1 day
(Serious) Adverse Events: acceptance criteria of occurrence of related adverse events should not exceed 10%.
Usability: Number of participants with no need for support
时间窗: 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: performance rate
时间窗: 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: exercise execution
时间窗: 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: device deficiencies
时间窗: 1 day
Acceptance criteria for occurence of any device deficiencies encountered during study visits is set to \<10%.
次要结局
- Usability: Player Experience(1 day)
- Usability: System Usability(1 day)
- Perceived physical and mental exertion/ effort(1 day)
研究者
Frank Behrendt
Sponsor-Investigator
Reha Rheinfelden