Mixed Reality With Hololens® Exercise Protocol
2019년 3월 15일 업데이트: 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.
연구 개요
상세 설명
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
연구 유형
중재적
등록 (실제)
15
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Madrid, 스페인, 28023
- CSEU La Salle
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Resistance test of the neck flexor muscles
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Cervical Joint Position Error Test
기간: 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)
기간: 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):
기간: 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):
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 10월 22일
기본 완료 (실제)
2019년 3월 15일
연구 완료 (실제)
2019년 3월 15일
연구 등록 날짜
최초 제출
2018년 9월 18일
QC 기준을 충족하는 최초 제출
2018년 10월 10일
처음 게시됨 (실제)
2018년 10월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 3월 19일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 15일
마지막으로 확인됨
2019년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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