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IRCT20230522058251N1 IRCT 2023-07-31 Shahid Beheshti University of Medical Sciences Assessing the effectiveness of VR therapy in the treatment of frozen shoulder Assessing the effectiveness of Virtual Reality (VR) therapy in patients with frozen shoulder 2023-08-30 anticipated 40 Complete https://irct.ir/trial/70369 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sealed envelope patient chooses a sealed envelope when he enters the study. The envelope contains either of the two labels reading control or intervention. N/A Frozen shoulder (Adhesive capsulitis). Intervention 1: Intervention group: 12 sessions of physiotherapy during 4 weeks (3 sessions each week) was done. Each session lasts one hour. The first 40 minutes was the same in both groups, which contains twenty minutes of passive exercise with CPM machine, followed by twenty minutes of functional exercises including flexion, abduction and external rotation. In the next twenty minutes, the virtual reality device is placed on the patient's head and the patient finds himself in a game environment, wielding a sword in his hand and obliged to hit the obstacles that appear in the game. The speed of the appearance of the obstacles and their arrangement have been adjusted by the study team so that the patient's hand movements as a result of trying to hit the obstacles have a rehabilitative nature. Intervention 2: Control group: 12 sessions of physiotherapy in a period of 4 weeks, 3 sessions each week, was done. The duration of each session was 40 minutes. In each session, after twenty minutes of passive training with the CPM machine, twenty minutes of functional exercises including flexion, abduction and external rotation were performed. Yes - There is a plan to make this available What will be shared: After de-identifying the participants (name removal), the data can be sent under an excel file including all demographic information and independent variables and results. When: all the specified data will be available 6 month after the publication of the results upon request from the corresponding author To whom: academic staff of all universities Conditions: standard scientific citation, and only to the researchers conducting the same research Where to obtain: corresponding author Mohammad Hossein Mahrooz mohamad.mahrooz@alum.sharif.edu Shahid Beheshti University of medical sciences, Tehran, Iran How to obtain: A mail or e-mail, requesting the required data, along with an attestation of non-disclosure of information to a third party Comments: for any further inquiries please contact the corresponding author via e-mail mohamad.mahrooz@alum.sharif.edu
public Mohammad Hossein Mahrooz
Shahid Beheshti Medical University, Aarabi st., Daneshjoo Blvd., Shahriari sq., Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9872 mohamad.mahrooz@alum.sharif.edu Shahid Beheshti University of Medical Sciences scientific Mohammad Hossein Mahrooz
Shahid Beheshti Medical University, Aarabi st., Daneshjoo Blvd., Shahriari sq., Velenjak
Tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9872 mohamad.mahrooz@alum.sharif.edu Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of frozen shoulder Informed consent to comply with the study protocols age between 18 and 65 years 18 years 65 years Both history of trauma or surgery in the affected shoulder history of any neurologic disease affecting the neuro-muscular function of the affected shoulder history of migraine history of seizure gait dysfunction vertigo or impaired stability M75.0 Adhesive capsulitis of shoulder Rehabilitation Rehabilitation Intervention group: 12 sessions of physiotherapy during 4 weeks (3 sessions each week) was done. Each session lasts one hour. The first 40 minutes was the same in both groups, which contains twenty minutes of passive exercise with CPM machine, followed by twenty minutes of functional exercises including flexion, abduction and external rotation. In the next twenty minutes, the virtual reality device is placed on the patient's head and the patient finds himself in a game environment, wielding a sword in his hand and obliged to hit the obstacles that appear in the game. The speed of the appearance of the obstacles and their arrangement have been adjusted by the study team so that the patient's hand movements as a result of trying to hit the obstacles have a rehabilitative nature. Control group: 12 sessions of physiotherapy in a period of 4 weeks, 3 sessions each week, was done. The duration of each session was 40 minutes. In each session, after twenty minutes of passive training with the CPM machine, twenty minutes of functional exercises including flexion, abduction and external rotation were performed. Shoulder function based on ِDisabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Timepoint: before the first session, and after the last session. Method of measurement: Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire. Pain level based on Visual Analogue Scale questionnaire. Timepoint: before the first session and after the final session. Method of measurement: Visual Analogue Score. Patient satisfaction level based on Visual Analogue Scale questionnaire. Timepoint: After the final session. Method of measurement: Visual Analogue Scale. Shahid Beheshti University of Medical Sciences Approved 2023-05-06 Iran national commettee for ethics in biomedical research Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)