Virtual Reality For Shoulder Dysfunction Post Neck Dissection Surgeries

NCT ID: NCT06257238

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-10-31

Brief Summary

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.

Detailed Description

1. Subjects: sixty eight patients from both genders, suffering from shoulder dysfunction post neck dissection surgery, their ages ranges from 40-60 years.

2. Design of the study:

In this study the patients will be randomly assigned into two equal groups (34 patients for each group):

1. 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.

2. 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:

• Measuring and assessment of pain by: Smart phone version of visual analogue scale (VAS).
• Measuring range of motion (ROM) by: Mobile application Goniometer.
• Measuring upper limb function by: The Arabic Version of Modified QuickDASH-9 Questionnaire.

Therapeutic equipment:

• Oculus Quest virtual reality (VR) headset with hand controller.

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.

Conditions

SHOULDER DYSFUNCTION

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fully immersive Head-Mounted Display Virtual Reality

Intervention Type: 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.

Traditional Physical Therapy Program

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Traditional Physical Therapy Program

Intervention Type: 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.

Interventions

Fully immersive Head-Mounted Display Virtual Reality

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.

Intervention Type: DEVICE

Traditional Physical Therapy Program

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Oculus Quest virtual reality headset with hand controller

Eligibility Criteria

Inclusion Criteria

• Age range between 40-60 years
• Both genders will participate in the study
• All patients have undergone neck dissection surgery
• All patients enrolled to the study will have their informed consent

Exclusion Criteria

• Age more than 60 years or less than 40 years
• Subjects who have hearing problems
• Subjects who have visual problems
• Patients have acute viral diseases, acute tuberculosis, mental disorders or those with pace makers

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hayaa Khaled Yahya Aly

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

H N Ashem, Professor

Role: STUDY_DIRECTOR

faculty of physical therapy

Locations

Faculty of Physical Therapy

Giza, Dokki, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

H K Aly, Master

Role: CONTACT

drhayaakhaled@gmail.com

01094012699 ext. +2

H N Ashem, Professor

Role: CONTACT

haidyjoj.hn@gmail.com

01275735585 ext. +2

Facility Contacts

H N Ashem, Professor

Role: primary

haidyjoj.hn@gmail.com

01275735585 ext. +2

N M Kamel, Lecturer

Role: backup

pt.noha.mohamed@gmail.com

01008013670 ext. +2

References

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Reference Type: BACKGROUND

PMID: 31907649 (View on PubMed)

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.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 15376608 (View on PubMed)

De Vet, H. C., Knol, D. L., Mokkink, L. B., and Terwee, C. B. (2011): Measurement in medicine: a practical guide. Cambridge university press.

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 30675577 (View on PubMed)

Blough, D. K., Carrougher, G. J., Hoffman, H. G., Nakamura, D., Patterson, D. R. and Sharar, S. R. (2007)

Reference Type: BACKGROUND

Other Identifiers

P.T.REC/012/004205

Identifier Type: -

Identifier Source: org_study_id