A Low-Cost Balance Training Platform Using Augmented Reality in Neurorehabilitation: a Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- System Usability Scale (SUS)
研究概览
简要总结
The goal of this clinical trial is to assess the Usability, adherence, acceptance, and security of an augmented reality platform for balance training in patients with balance disorders due to degenerative injuries or cerebrovascular diseases.
The main questions it aims to answer are:
- Is the augmented reality system usable, acceptable, and safe with good adherence?
- Does the system improve the balance in our population?
- Participants will be asked to assist at Vall d'Hebrón Hospital, where patients will undergo balance training under the supervision of a physiotherapist three days a week for four weeks.
- If the patients meet the inclusion criteria, the intervention will be extended for two more weeks at home.
详细描述
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INTERVENTION The first phase of the intervention will last four weeks and will be done in the hospital. After this intervention, if the patients meet the inclusion criteria, they will be enrolled in the second phase, which will be done at the patient's home for two additional weeks. Three assessments will be performed during the study: The first one ("Day 0") will be assessed before starting the treatment, the second one will be done ("Week 4") directly after the intervention at a hospital setting, and the last one ("Week 6"), after the home intervention. The intervention will be conducted in 1-hour sessions three times a week for four weeks, performing different exercises using an augmented reality platform accessed through RGSweb. If the patients continue the intervention at home, a three-session training for two weeks will be conducted in the presence of a patient's relative, who will accept to be the training partner.
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EQUIPMENT AND TECHNICAL SPECIFICATIONS. RGSweb can be used with any computer or device with a camera. However, our target users are patients who might have visibility issues due to old age. Therefore, bigger screens will be used to enhance the patients'; visibility. Additional screen support will be required to hold the monitor.
There are three protocols in RGSweb:
Twister Buddy: It has been developed for balance training, which involves a series of levels intended to strengthen the muscles crucial for maintaining upright posture, notably those in the legs. The aim is to improve stability and help prevent falls.
Levels The user will have to shift their weight from one leg to the other while doing different exercises, such as touching targets with their hands and feet or taking steps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Balance impairment due cerebrovascular diseases or neurodegenerative diseases.
- •Being able to mantain standing for 2 minuts without assistance.
- •Berg scale ≥21
- •Signing informed consent
- •To have a training partner during the exercises at home.
- •No fall attempt during hospital intervention
- •No have enough space to train safely at their home.
- •Being familiar with technological devices such a laptop, tablets or inteligent cellphones.
排除标准
- •The presence of a condition or abnormality that could compromise the patient's safety.
- •Severe cognitive impairments tha prevent the execution of the xperiment (MoCA <19)
- •Presence of sensory aphasia.
- •Diagnostic of conduct disorders.
- •Presence of severe neglect.
- •Spasticity =4 in MAS lower limb.
结局指标
主要结局
System Usability Scale (SUS)
时间窗: "Week 4" "Week 6"
The System Usability Scale is a reliable tool for measuring usability. It consists of a 10-item questionnaire with five response options for respondents, from Strongly Agree to Disagree Strongly. A value above 68 points is considered acceptable.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
时间窗: "Week 4" "Week 6"
The instrument is a self-administered questionnaire assessing user satisfaction with assistive technology product and associated services.
User Esperience Questionnaire (UEQ)
时间窗: "Week 4" "Week 6"
The scales of the questionnaire cover comprehensive impression of user experience. Both classical usability aspects (efficiency, perspicuity, dependability) and user experience (originality stimulation) are measured. The items are scaled from -3 to +3. Thus, -3 represents the most negative answer, 0 a neutral answer, and +3 the most positive answer.
Adherence (Home)
时间窗: "Week 6"
Time the Augmentad reality system is used in comparision to the scheduled dosage.
Adherence (Hospital)
时间窗: "Week 4"
Total sessions scheduled for therapy compared to the number of sessions attended
Ad-hoc questions
时间窗: "Day 0" "Week 4" "Week 6"
Questions to assess the attitude towards the system and to gather data on privacy and feeling of stigma.
次要结局
- Berg Balance Scale("Day 0" "Week 4" "Week 6")
- Postural Sway("Day 0" "Week 4" "Week 6")
- Five Times Sit to Stand Test (FTSS)("Day 0" "Week 4" "Week 6")
- The Activities-specific Balance Confidence (ABC) Scale.("Day 0" "Week 4" "Week 6")
- The EuroQol-5 Dimension-5 Level (EQ-5D-5L)("Day 0" "Week 4" "Week 6")