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Assessing the effectiveness of Virtual Reality (VR) therapy in patients with frozen shoulder

Protocol summary

Study aim
Assessing the effectiveness of Virtual Reality (VR) therapy in patients with frozen shoulder
Design
A randomised controlled clinical trial with parallel groups, and blinded outcome assessment, on 40 patients. Randomisation was performed using concealed envelopes.
Settings and conduct
The place of study is Akhtar Orthopedic Hospital, and on the patients who were diagnosed with frozen shoulder in the clinic of this hospital. Due to the nature of the intervention, unilateral or bilateral blinding was not possible. Although the statistical analysis was done blindly by a third party.
Participants/Inclusion and exclusion criteria
Inclusion criteria included a diagnosis of frozen shoulder based on clinical assessment, age between 18 and 65 years, and willingness to comply with the study protocol. Exclusion criteria encompassed individuals with a history of severe shoulder trauma or surgery, neurological conditions affecting shoulder function, uncontrolled systemic diseases, gait dysfunction, stability dysfunction, history of migraine and seizure
Intervention groups
Participants were randomized into two groups, namely, the VR group and the conventional group. Both groups underwent a 12-session program during four weeks. The conventional group participants received 40 minutes of conventional therapy, consisting of Continuous Passive Motion (CPM) and functional exercises including flexion, abduction and external rotation. The VR group received the conventional therapy module, plus 20 minutes of VR exergaming at the end of each session.
Main outcome variables
Shoulder pain, measured by VAS questionnaire Shoulder function measured by DASH questionnaire

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230522058251N1
Registration date: 2023-07-31, 1402/05/09
Registration timing: prospective

Last update: 2023-07-31, 1402/05/09
Update count: 0
Registration date
2023-07-31, 1402/05/09
Registrant information
Name
Mohammad Hossein Mahrooz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 130 8261
Email address
mohamad.mahrooz@alum.sharif.edu
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-30, 1402/06/08
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of Virtual Reality (VR) therapy in patients with frozen shoulder
Public title
Assessing the effectiveness of VR therapy in the treatment of frozen shoulder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Clinical diagnosis of frozen shoulder Informed consent to comply with the study protocols age between 18 and 65 years
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran national commettee for ethics in biomedical research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1111111111
Approval date
2023-05-06, 1402/02/16
Ethics committee reference number
IR.SBMU.MSP.REC.1402.010

Health conditions studied

1

Description of health condition studied
Frozen shoulder (Adhesive capsulitis)
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder

Primary outcomes

1

Description
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

2

Description
Pain level based on Visual Analogue Scale questionnaire
Timepoint
before the first session and after the final session
Method of measurement
Visual Analogue Score

3

Description
Patient satisfaction level based on Visual Analogue Scale questionnaire
Timepoint
After the final session
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar orthopaedic surgery center
Full name of responsible person
Mohammad Hossein Mahrooz
Street address
Azar deadend, SharifiManesh street, Shariati Avenue
City
Tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Fax
+98 21 2260 8246
Email
akhtarhospital@sbmu.ac.ir
Web page address
https://amc.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
5th floor, No2, Shahid Arabi street, Yaman avenue, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 9780
Fax
+98 21 2990 2650
Email
info@sbmu.ac.ir
Web page address
https://research.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hossein Mahrooz
Position
Medical intern
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Medical University, Aarabi st., Daneshjoo Blvd., Shahriari sq., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9872
Email
mohamad.mahrooz@alum.sharif.edu

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hossein Mahrooz
Position
Medical intern
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Medical University, Aarabi st., Daneshjoo Blvd., Shahriari sq., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9872
Email
mohamad.mahrooz@alum.sharif.edu

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Hossein Mahrooz
Position
Medical intern
Latest degree
Master
Other areas of specialty/work
Orthopedics
Street address
Shahid Beheshti Medical University, Aarabi st., Daneshjoo Blvd., Shahriari sq., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9872
Email
mohamad.mahrooz@alum.sharif.edu

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
all the specified data will be available 6 month after the publication of the results upon request from the corresponding author
To whom data/document is available
academic staff of all universities
Under which criteria data/document could be used
standard scientific citation, and only to the researchers conducting the same research
From where data/document is obtainable
corresponding author Mohammad Hossein Mahrooz mohamad.mahrooz@alum.sharif.edu Shahid Beheshti University of medical sciences, Tehran, Iran
What processes are involved for a request to access data/document
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
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