Mixed Reality With Hololens® Exercise Protocol
2019年3月15日 更新者：Hector Beltran-Alacreu、Centro Universitario La Salle
Effectiveness of Mixed Reality With the Hololens System Versus Conventional Cervical Exercise Program for Asymptomatic Subjects. Crossover Pilot Study
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.
研究概览
详细说明
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
研究类型
介入性
注册 (实际的)
15
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Madrid、西班牙、28023
- CSEU La Salle
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 40年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Mixed reality
Mixed reality exercise program using the Microsoft Hololens "Roboraid" game.
This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions, using the Microsoft Hololens "Roboraid" game.
The duration of the sessions will be 10 minutes.
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This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions, using the Microsoft Hololens "Roboraid" game.
The duration of the sessions will be 10 minutes.
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有源比较器：Conventional exercise group
Conventional exercise program in cervical region based in deep neck flexors and deep neck extensors, isometric contraction during 6-8 seconds.
This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions.
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This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions.
This program will consist on stabilisation exercises of the cervical region, in neck deep flexors and neck deep extensors muscles to provide them with strength and resistance
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Resistance test of the neck flexor muscles
大体时间：change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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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.
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change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Cervical Joint Position Error Test
大体时间：change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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The aim of this test is to assess the subject's ability to return to the starting position after a cervical rotation movement has been performed.
The patient will remain seated in a chair with a backrest.
You will be given a headband with a laser pointer.
At 90 cm, a stitch (a kind of target) will be placed.
With the eyes closed, the participant will be asked to perform a cervical rotation and return to the starting position, as precisely as possible and without any feedback.
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change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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Evaluation of User Satisfaction with Auxiliary Device Technology (QUEST 2.0)
大体时间：change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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This consists of 12 questions, each one of which the participant should circle with a circle the number that best describes his or her degree of satisfaction from 1 to 5 (1 being unsatisfied and 5 very satisfied)
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change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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System Usability Scale (SUS):
大体时间：change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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It consists of 10 questions and the participant should dial the number that best describes their degree of satisfaction from 1 to 5 (1 being unsatisfied and 5 very satisfied)
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change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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Suitability Evaluation Questionnaire (SEQ):
大体时间：change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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Made up of 14 questions, one of which is an open-ended question.
For the remaining questions, the participant must select the number that best fits his or her answer, from 1 to 5, range 13 to 65 points.
Higher values represent more dificulty using the device.
This questionnaire assesses the subject's satisfaction and also the difficulty of its use.
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change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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Q-Sense (Thermotest)
大体时间：change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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Q-Sense is a validated device for the measurement of heat/cold thresholds and painful heat thresholds.
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change measures (Baseline, 3 weeks, 7 weeks, 10 weeks and 14 weeks)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Edwards RR, Smith MT, Stonerock G, Haythornthwaite JA. Pain-related catastrophizing in healthy women is associated with greater temporal summation of and reduced habituation to thermal pain. Clin J Pain. 2006 Oct;22(8):730-7. doi: 10.1097/01.ajp.0000210914.72794.bc.
- Hoffman HG, Seibel EJ, Richards TL, Furness TA, Patterson DR, Sharar SR. Virtual reality helmet display quality influences the magnitude of virtual reality analgesia. J Pain. 2006 Nov;7(11):843-50. doi: 10.1016/j.jpain.2006.04.006.
- Harris KD, Heer DM, Roy TC, Santos DM, Whitman JM, Wainner RS. Reliability of a measurement of neck flexor muscle endurance. Phys Ther. 2005 Dec;85(12):1349-55.
- Beltran-Alacreu H, Lopez-de-Uralde-Villanueva I, Fernandez-Carnero J, La Touche R. Manual Therapy, Therapeutic Patient Education, and Therapeutic Exercise, an Effective Multimodal Treatment of Nonspecific Chronic Neck Pain: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2015 Oct;94(10 Suppl 1):887-97. doi: 10.1097/PHM.0000000000000293.
- Juul T, Langberg H, Enoch F, Sogaard K. The intra- and inter-rater reliability of five clinical muscle performance tests in patients with and without neck pain. BMC Musculoskelet Disord. 2013 Dec 3;14:339. doi: 10.1186/1471-2474-14-339.
- Shahrbanian S, Ma X, Korner-Bitensky N, Simmonds MJ. Scientific evidence for the effectiveness of virtual reality for pain reduction in adults with acute or chronic pain. Stud Health Technol Inform. 2009;144:40-3.
- Penasco-Martin B, de los Reyes-Guzman A, Gil-Agudo A, Bernal-Sahun A, Perez-Aguilar B, de la Pena-Gonzalez AI. [Application of virtual reality in the motor aspects of neurorehabilitation]. Rev Neurol. 2010 Oct 16;51(8):481-8. Spanish.
- Demers L, Monette M, Lapierre Y, Arnold DL, Wolfson C. Reliability, validity, and applicability of the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST 2.0) for adults with multiple sclerosis. Disabil Rehabil. 2002 Jan 10-Feb 15;24(1-3):21-30. doi: 10.1080/09638280110066352.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年10月22日
初级完成 (实际的)
2019年3月15日
研究完成 (实际的)
2019年3月15日
研究注册日期
首次提交
2018年9月18日
首先提交符合 QC 标准的
2018年10月10日
首次发布 (实际的)
2018年10月12日
研究记录更新
最后更新发布 (实际的)
2019年3月19日
上次提交的符合 QC 标准的更新
2019年3月15日
最后验证
2019年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Mixed reality的临床试验
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Southern Methodist UniversityKing's College London完全的
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IRCCS Eugenio Medea招聘中