- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369934
Virtual Reality Based Exercise Training Versus Mulligan Mobilization on Shoulder Posture and Function in Subacromial Impingement Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara M Meselhy, Demonstrator
- Phone Number: +01222518092
- Email: sara.mohsen@cu.edu.eg
Study Contact Backup
- Name: Afaf M Tahoon, lecturer
- Phone Number: +01015401783
- Email: Afaf_tahoon@cu.edu.eg
Study Locations
-
-
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Giza, Egypt
- Recruiting
- Faculty of physical therapy, Cairo University
-
Contact:
- Afaf M Tahoon, lecturer
- Phone Number: +01015401783
- Email: Afaf_tahoon@cu.edu.eg
-
Principal Investigator:
- Sara M Meselhy, Demostrator
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients will be referred from the orthopedic surgeon with a diagnosis of stage II SIS with the following criteria:
- Participants ranged in age from 30-50 years old.
- Participants are from non-athletes from the general population.
- Unilateral shoulder pain that is localized either anteriorly or laterally to the acromion. Pain that occurs or worsens when the affected shoulder is in flexion and/or abduction.
- Four of the following should be present in the included patients: Neer impingement test, Hawkins' test, Pain was replicated in the supraspinatus empty-can test, a painful arc of movement from 70° to 120°, and painful greater tuberosity of the humerus.
- BMI range 18.5- 29.9 Kg/m².
Exclusion Criteria:
1) Patients who, during the previous three months, underwent shoulder physical treatment and/or an acute pain flare.
2) Patients who have undergone surgeries for tendon repair. 3) Malignancy, epilepsy, pregnant women, and/or systemic conditions like chronic renal or liver failure.
4) Mini-Mental State Examination test (MMSE) (< 24/30) to exclude cognitive impairment and/or significant vision impairment (if they couldn't read the introduction while wearing the Head Mounted Device (HMD).
5) Corticosteroid injection during the last three months or used steroids chronically.
6) Adhesive capsulitis, glenohumeral joint instability, Numbness or tingling of the upper limb, and/or full-thickness tear of the rotator cuff.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Virtual reality group
|
Fully immersive virtual reality mounted headset will be used
|
|
Active Comparator: Mulligan mobilization group
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posterolateral shoulder Mulligan mobilization with movement (MWM) will be used
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity during shoulder elevation
Time Frame: pain intensity at the start of session 1 to the end of 1 month of treatment
|
It will be measured using the Numerical Pain Rating Scale (NPRS)
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pain intensity at the start of session 1 to the end of 1 month of treatment
|
|
Shoulder function
Time Frame: shoulder function at the start of session 1 to the end of 1 month of treatment
|
The Shoulder Pain and Disability Index (SPADI) will be used to measure the shoulder function.
|
shoulder function at the start of session 1 to the end of 1 month of treatment
|
|
Shoulder flexion range of motion
Time Frame: shoulder flexion at the start of session 1 to the end of 1 month of treatment
|
The Clinometer Application will be used to measure it.
|
shoulder flexion at the start of session 1 to the end of 1 month of treatment
|
|
Shoulder abduction range of motion
Time Frame: shoulder abduction at the start of session 1 to the end of 1 month of treatment
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The Clinometer Application will be used to measure it.
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shoulder abduction at the start of session 1 to the end of 1 month of treatment
|
|
shoulder posture
Time Frame: shoulder posture at the start of session 1 to the end of 1 month of treatment
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Sagittal Shoulder Angle will be used to measure the shoulder posture
|
shoulder posture at the start of session 1 to the end of 1 month of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patients' enjoyment
Time Frame: It will be evaluated at the end of the last session (after 1 month)
|
A 7-point likert scale will be used to the evaluate the level of the patients' enjoyment at the end of the last session.
|
It will be evaluated at the end of the last session (after 1 month)
|
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patients' adherence to treatment sessions
Time Frame: patients' adherence at the start of session 1 to the end of 1 month of treatment
|
patients' numbers of attended sessions will be calculated at the end of 1 month of treatment.
|
patients' adherence at the start of session 1 to the end of 1 month of treatment
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Enas Fawzy Youssed, Professor Doctor, Cairo University
- Study Director: Afaf M Tahoon, lecturer, Cairo University
- Study Director: Mohamed A Kotb, Assistant professor, Cairo University
Publications and helpful links
General Publications
- Steiner, B., Elgert, L., Saalfeld, B., & Wolf, K. H. (2020). Gamification in rehabilitation of patients with musculoskeletal diseases of the shoulder: scoping review. JMIR serious games, 8(3), e19914. https://doi.org/10.2196/19914
- Smith, J., & Doe, A. (2023). Virtual embodiment for improving range of motion in patients with movement-related shoulder pain: An experimental study. Journal of Rehabilitation Science, 45(2), 123-134.
- Lin, H. T., Li, Y. I., Hu, W. P., Huang, C. C., & Du, Y. C. (2019). A scoping review of the efficacy of virtual reality and exergaming on patients of musculoskeletal system disorder. Journal of clinical medicine, 8(6), 791. https://doi.org/10.3390/jcm8060791
- Hoyek, N., Di Rienzo, F., Collet, C., Hoyek, F., & Guillot, A. (2014). The therapeutic role of motor imagery on the functional rehabilitation of a stage II shoulder impingement syndrome. Disability and rehabilitation, 36(13), 1113-1119.
- Consigliere, P., Haddo, O., Levy, O., & Sforza, G. (2018). Subacromial impingement syndrome: management challenges. Orthopedic research and reviews, 83-91. https://doi.org/10.2147/ORR.S157864
- Coja, D. M., Onu, I., Onu, A., Iordan, D. A., Gheorghiu, G., Ene-Voiculescu, V., & Talaghir, L. G. (2024). The Use of Virtual Reality-Assisted Therapy to Improve Shoulder function in Subacromial Impingement Syndrome: a Randomised Controlled Trial. BRAIN. Broad Research in Artificial Intelligence and Neuroscience, 15(4), 11-26. http://dx.doi.org/10.70594/brain/15.4/2
- Chaplin, E., Karatzios, C., & Benaim, C. (2023, December). Clinical applications of virtual reality in musculoskeletal rehabilitation: A scoping review. In Healthcare (Vol. 11, No. 24, p. 3178). MDPI. https://doi.org/10.3390/healthcare11243178
- Álvarez de la Campa Crespo, M., Donegan, T., Amestoy-Alonso, B., Just, A., Combalía, A., & Sanchez-Vives, M. V. (2023). Virtual embodiment for improving range of motion in patients with movement-related shoulder pain: An experimental study. Journal of Orthopaedic Surgery and Research, 18(1), 729. https://doi.org/10.1186/s13018-023-04158-w
- Özlü, A., Üstündağ, S., Bulut Özkaya, D., & Menekşeoğlu, A. K. (2024). Effect of exergame on pain, function, and quality of life in shoulder impingement syndrome: a prospective randomized controlled study. Games for Health Journal, 13(2), 109-119. https://doi.org/10.1089/g4h.2023.0108
- Gumaa, M., & Rehan Youssef, A. (2019). Is virtual reality effective in orthopedic rehabilitation? A systematic review and meta-analysis. Physical therapy, 99(10), 1304-1325. https://doi.org/10.1093/ptj/pzz093
- Dias, D., Neto, M. G., Sales, S. D. S. R., Cavalcante, B. D. S., Torrierri Jr, P., Roever, L., & Araujo, R. P. C. D. (2023). Effect of mobilization with Movement on Pain, disability, and Range of Motion in patients with Shoulder Pain and Movement Impairment: a systematic review and Meta-analysis. Journal of Clinical Medicine, 12(23), 7416. https://doi.org/10.3390/jcm12237416
- Delgado-Gil, J. A., Prado-Robles, E., Rodrigues-de-Souza, D. P., Cleland, J. A., Fernández-de-las-Peñas, C., & Alburquerque-Sendín, F. (2015). Effects of mobilization with movement on pain and range of motion in patients with unilateral shoulder impingement syndrome: a randomized controlled trial. Journal of manipulative and physiological therapeutics, 38(4), 245-252. https://doi.org/10.1016/j.jmpt.2014.12.008
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Virtual reality and Mulligan M
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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