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The goal of this clinical trial study: is to determine the effect of Virtual reality on pain and function for shoulder dysfunction post neck dissection surgeries. The main question is: Can Virtual reality technique affect the dysfunction of shoulder joint post neck dissection surgeries? Participants will receive the treatment for 2 times per week for 2 months. Assessment will be done before and after treatment.
In this study the patients will be randomly assigned into two equal groups (34 patients for each group):
Group A (Study group):
This group includes 34 patients suffering from pain and loss of shoulder flexion, abduction and external rotation ROM, patients will be treated with active ROM exercise, stretching exercise for shoulder extensors, adductors and internal rotators muscles and strengthening exercise for shoulder muscles, and with fully immersive Head-Mounted Display virtual reality (Oculus Quest virtual reality (VR) headset with hand controller) for 30 min. 2 times per week for 2 months.
Group B (Control group):
This group includes 34 patients suffering from pain and loss of shoulder flexion, abduction and external rotation ROM, patients will be treated with traditional physical therapy: active ROM exercise, stretching exercise for shoulder extensors, adductors and internal rotators muscles and strengthening exercise for shoulder muscles, 2 times per week for 2 months.
- Equipments:
Measuring tools:
Therapeutic equipment:
Each patient will play 3 games 10 min. for each with 1 min. rest in between. First game is Dance loop gameplay, there are throwing balls moving toward the patient in all directions, and the patient tries to catch all of them by the arm controllers, so it promote the movement of the arm toward flexion, abduction and external rotation directions.
Second game is Tennis ball, which promote the arm to move toward flexion, abduction and external rotation directions.
Third game is Boxing, which promote the arm to move toward flexion and abduction directions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | The study group includes 38 post neck dissection surgeries with shoulder dysfunction patients treated with fully immersive Head-Mounted Display virtual reality (Oculus Quest virtual reality (VR) headset with hand controller) for 30 min., each session includes three games exercise (Dance loop, Tennis and Boxing) with 10 min. for each game and 1 min. rest in between; in addition to their physical therapy program (Active ROM exercise for shoulder, Stretching exercise for shoulder extensors, adductors and internal rotators muscles and Strengthening exercise for shoulder muscles) 2 sessions per week for 2 months. |
|
| Active comparator | Active Comparator | The study group includes 38 post neck dissection surgeries with shoulder dysfunction patients treated with traditional physical therapy program (Active ROM exercise for shoulder, Stretching exercise for shoulder extensors, adductors and internal rotators muscles and Strengthening exercise for shoulder muscles) 2 sessions per week for 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully immersive Head-Mounted Display Virtual Reality | Device | patients are asked to wear the Oculus Quest VR on their heads and to hold the hand controllers by their hands and start the game exercises (Dance loop, Tennis ball and Boxing) with 10 min. for each game with 1 min. rest in between, plus the traditional PT program:(Active ROM exercise for shoulder, Stretching exercise for shoulder extensors, adductors and internal rotators muscles and Strengthening exercise for shoulder muscles) 2 sessions per week for 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Smart phone version of visual analogue scale (VAS) | Each patient determine his level of pain using an electronic version of a visual analogue scale, which is a validated, subjective measure for acute and chronic pain, by asking the user to mark a point on a line with minimum score of 0 "no pain" which is the best outcome and maximum score of 10 "worst pain possible" which is the worst outcome, which will be very helpful in the continuous monitoring of symptom diaries, feasible and efficient both for users and researcher. | Assessing the change of the scores from baseline (beginning of treatment) to 2 months after treatment. |
| Mobile application Goniometer | One android mobile will be used in the study and the software will not be updated during data collection. Goniometer record apps will be used to measure shoulder range of movements (ROM) | Assessing the change of the scores from baseline (beginning of treatment) to 2 months after treatment. |
| The Arabic Version of Modified QuickDASH-9 Questionnaire | The Arabic Modified Quick DASH-9, abbreviated from "Modified Quick Disabilities Arm Shoulder and Hand(DASH) questionnaire, is a single page; it consists of nine items extracted from The Quick DASH and DASH scales which concern the patient's upper extremity functions, with minimum score of 0 "no difficulty to perform all the activities" which is the best outcome and maximum score of 99 "unable to perform all the activities" which is the worst outcome. | Assessing the change of The Arabic Version of Modified QuickDASH-9 Questionnaire score from baseline (beginning of treatment) to 2 months after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| H K Aly, Master | Contact | 01094012699 | +2 | drhayaakhaled@gmail.com |
| H N Ashem, Professor | Contact | 01275735585 | +2 | haidyjoj.hn@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| H N Ashem, Professor | faculty of physical therapy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy | Recruiting | Giza | Dokki | 11432 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31907649 | Background | Feyzioglu O, Dincer S, Akan A, Algun ZC. Is Xbox 360 Kinect-based virtual reality training as effective as standard physiotherapy in patients undergoing breast cancer surgery? Support Care Cancer. 2020 Sep;28(9):4295-4303. doi: 10.1007/s00520-019-05287-x. Epub 2020 Jan 6. | |
| Background | El-Sayed D, Khalaf M, Hussein M. Psychometric properties of Arabic version of the modified QuickDASH-9 scale to measure the quality of recovery after dorsal hand burn injury. Int J Pharmtech Res. 2016;9(8):09-15. | ||
| 15376608 |
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Control group: (34 patients with shoulder dysfunction) receive traditional PT for shoulder dysfunction post neck dissection surgeries.
Study group: (34 patients with shoulder dysfunction) receive fully immersive Head-Mounted Display virtual reality exercise plus traditional PT for shoulder dysfunction post neck dissection surgeries.
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| Traditional Physical Therapy Program | Behavioral | patients are treated with Active ROM exercise for shoulder, Stretching exercise for shoulder extensors, adductors and internal rotators muscles and Strengthening exercise for shoulder muscles, 2 sessions per week for 2 months. |
|
| Background |
| Patterson DR, Hoffman HG, Weichman SA, Jensen MP, Sharar SR. Optimizing control of pain from severe burns: a literature review. Am J Clin Hypn. 2004 Jul;47(1):43-54. doi: 10.1080/00029157.2004.10401474. No abstract available. |
| Background | De Vet, H. C., Knol, D. L., Mokkink, L. B., and Terwee, C. B. (2011): Measurement in medicine: a practical guide. Cambridge university press. |
| 30675577 | Background | Mejia-Hernandez K, Chang A, Eardley-Harris N, Jaarsma R, Gill TK, McLean JM. Smartphone applications for the evaluation of pathologic shoulder range of motion and shoulder scores-a comparative study. JSES Open Access. 2018 Mar 13;2(1):109-114. doi: 10.1016/j.jses.2017.10.001. eCollection 2018 Mar. |
| Background | Blough, D. K., Carrougher, G. J., Hoffman, H. G., Nakamura, D., Patterson, D. R. and Sharar, S. R. (2007) |