Effectiveness of Mixed Reality With the Hololens System Versus Conventional Cervical Exercise Program for Asymptomatic Subjects. Crossover Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Resistance test of the neck flexor muscles
研究概览
简要总结
The study design is a cross-over pilot study with 15 asymptomatic subjects. There will be 2 groups, mixed reality group and conventional cervical exercise program. Both groups received 2 sessions per week with an interval of 48 hours between them during 3 consecutive weeks.
详细描述
The study design is a cross-over pilot study. The study was approved by the ethical committee of the Centro Superior de Estudios Universitarios La Salle. People were recruited by referral from different places of the local community of Madrid according to the CONSORT statement (Consolidated Standards of Reporting Trials). Three assessors were trained during 300 minutes about how to perform the measurements (Investigator A) and the concerned intervention to each group (Investigator B and C). The whole procedure was conducted in the Centro Superior de Estudios Universitarios La Salle. After meeting the eligibility criteria for the study, participants were randomly allocated by an external investigator to one of the two groups:
- Mixed reality group
- Conventional Exercise group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 40,
- •Not experienced any neck and upper limb symptom
- •Have no significant history of chronic pain disorder,
- •Did not use any medication,
- •Understand, write and speak Spanish fluently.
排除标准
- •Craniocervical pain, peripheral neuropathy or history of migraine.
- •Endocrine disorders, epilepsy or any psychiatric disorder, neurological disorder.
- •Surgery and a history of traumatic injuries of the upper limb
结局指标
主要结局
Resistance test of the neck flexor muscles
时间窗: change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
To perform this test that will give us the resistance in seconds, the therapist lifts the patient's head and neck until the occipital bone is approximately 2.5 cm from the table, keeping the chin tucked into the chest.
次要结局
- Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)(change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks))
- Cervical Joint Position Error Test(change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks))
- Q-Sense (Thermotest)(change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks))
- Suitability Evaluation Questionnaire (SEQ):(change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks))
- System Usability Scale (SUS):(change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks))
研究者
Hector Beltran-Alacreu
Professor
Centro Universitario La Salle