Virtual Reality For Shoulder Dysfunction Post Neck Dissection Surgeries

NCT06257238 | Recruiting

• 1 other identifier: P.T.REC/012/004205
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

SHOULDER DYSFUNCTION

Keywords

SHOULDER DYSFUNCTION - NECK DISSECTION SURGERIES

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (2)

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.

Device: Fully immersive Head-Mounted Display Virtual Reality; Behavioral: Traditional Physical Therapy Program

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.

Behavioral: Traditional Physical Therapy Program

Interventions

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.

Also known as: Oculus Quest virtual reality headset with hand controller

Experimental

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.

Active comparator; Experimental

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Dokki, 11432, Egypt

RECRUITING

Related Publications (6)

• 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.

  PMID: 31907649 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.

  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.

  PMID: 15376608 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.

  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.

  PMID: 30675577 BACKGROUND

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

  BACKGROUND

Study Officials

• H N Ashem, Professor

  faculty of physical therapy

  STUDY DIRECTOR

Central Study Contacts

H K Aly, Master

CONTACT

01094012699; drhayaakhaled@gmail.com

H N Ashem, Professor

CONTACT

01275735585; haidyjoj.hn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)