- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05961033
The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
The Effects of Virtual Reality Based Exercises on Pain, Range of Motion and Quality of Life in Patients With Adhesive Capsulitis
Musculoskeletal disorders such as adhesive capsulitis (AC) affect tissues such as muscles, bones, joints, tendons and ligaments and are the second most disabling condition worldwide. Musculoskeletal Systemic disorders are typically characterized by pain, limitations in joint range of motion or functional ability.
Existing studies have shown that Virtual Reality (VR) is beneficial in pain management for example; pain relief during dressing changes in burn patients. VR can also reduce anxiety, distract from the fear of pain, and reduce stress. It can distract the patients who are afraid of moving due to pain and enable them to move freely. In this study, AC patients will be treated with VR application. Patients pain levels, upper extremity range of motion, functional activity levels and quality of life levels will be evaluated. A total of 36 patients will be included in the study.
This observational randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individuals in the first group to be included in the study group will be included in a VR-based exercise program for half an hour a day, 5 days a week for a total of 4 weeks, in addition to routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks. These individuals will use the Oculus Quest 2 VR system in the virtual environment thanks to the three-dimensional glasses and handpiece that can be worn on the head. They will play the registered games. These games will include purpose-oriented activities such as lying on the head and using bilaterally, which are intended to use the upper extremities of individuals with AC in daily life. Participants will be treated under the constant supervision of a physiotherapist, will be rested at the end of the exercise, and will leave the clinic after making sure that there is no problem.
Individuals in the second group, who will be included in the traditional exercise group, will be included in the stretching and strengthening exercise program for half an hour a day, 5 days a week for a total of 4 weeks, for a total of 10 hours, in addition to the routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.
Pain levels (Visual Analogue Scale), upper extremity range of motion (Goniometric measurement), functional activity levels (Shoulder Pain and Disability Index) and quality of life (SF-36) of all participants will be evaluated before and after the study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kocaeli, Turkey (Türkiye)
- Kocaeli University Faculty of Medicine Hospital
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Sakarya, Turkey (Türkiye)
- Sakarya University Physiotherapy and Rehabilitation Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being between the ages of 18-65
- Clinical diagnosis of adhesive capsulitis
Exclusion Criteria:
- Inability to cooperate VR
- Surgery on the upper extremity or trunk
- Neurological disease
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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study
Individuals in the first group to be included in the study group will be included in a virtual reality-based exercise program for half an hour a day, 5 days a week for a total of 4 weeks, in addition to routine electrotherapy programs for half an hour a day, 5 days a week for a total of 4 weeks.
These individuals will be able to play the games saved in the Oculus Quest 2 SG system in the virtual environment, thanks to the three-dimensional glasses and handpiece that can be worn on the head.
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Play VR games
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control
Individuals who receive traditional electrotherapy and exercise program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain severity change
Time Frame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
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pain intensity after VR based exercises will be assessed by Visual Analogue Scale (VAS).
VAS is often used to measure the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain (0-10).
Ten shows more pain intensity.
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Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
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Quality of Life level change
Time Frame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
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Level of Quality of Life will be assessed by Short Form- 36 (SF-36).
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures.
These measures rely upon patient self-reporting and have been widely used.
High points show high quality ol life levels.
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Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
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Shoulder functionality level change
Time Frame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
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Shoulder functionality will be assessed by Shoulder and Pain Disability Inventory (SPADI).
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
The pain dimension consists of five questions regarding the severity of an individual's pain.
Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
The means of the two subscales are averaged to produce a total score ranging from 0 (best) to 100 (worst).
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Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Shoulder mobility angles change
Time Frame: Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
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Shouder mobility will be assessed by goniometric measurement
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Initial assessment before playing VR exercises, secondary assessment after 4 weeks VR based exercises
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 32/22
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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