Skip to content

Virtual Reality For Shoulder Dysfunction Post Neck Dissection Surgeries

Virtual Reality For Shoulder Dysfunction Post Neck Dissection Surgeries

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06257238
Enrollment
68
Registered
2024-02-13
Start date
2023-09-01
Completion date
2024-10-31
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SHOULDER DYSFUNCTION

Keywords

SHOULDER DYSFUNCTION - NECK DISSECTION SURGERIES

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.

Interventions

DEVICEFully 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.

BEHAVIORALTraditional 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.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Smart phone version of visual analogue scale (VAS)Assessing the change of the scores from baseline (beginning of treatment) to 2 months after treatment.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.
Mobile application GoniometerAssessing the change of the scores from baseline (beginning of treatment) to 2 months after treatment.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)
The Arabic Version of Modified QuickDASH-9 QuestionnaireAssessing the change of The Arabic Version of Modified QuickDASH-9 Questionnaire score from baseline (beginning of treatment) to 2 months after treatment.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.

Countries

Egypt

Contacts

Primary ContactH K Aly, Master
drhayaakhaled@gmail.com01094012699
Backup ContactH N Ashem, Professor
haidyjoj.hn@gmail.com01275735585

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026