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.
調査の概要
詳細な説明
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
研究の種類
介入
入学 (実際)
15
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Madrid、スペイン、28023
- CSEU La Salle
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～40年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Resistance test of the neck flexor muscles
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Cervical Joint Position Error Test
時間枠：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)
時間枠：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):
時間枠：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):
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年10月22日
一次修了 (実際)
2019年3月15日
研究の完了 (実際)
2019年3月15日
試験登録日
最初に提出
2018年9月18日
QC基準を満たした最初の提出物
2018年10月10日
最初の投稿 (実際)
2018年10月12日
学習記録の更新
投稿された最後の更新 (実際)
2019年3月19日
QC基準を満たした最後の更新が送信されました
2019年3月15日
最終確認日
2019年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Mixed realityの臨床試験
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Wen-zhao ZHONGGuangdong Provincial People's Hospitalわからない肺癌 | 肺結節、孤立性 | 多発性肺結節 | ビデオ支援胸部手術中国