Adhesive CapsulitisNCT06201325
The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
A study testing virtual reality based exercises, conventional physical therapy and home exercises program in people with Adhesive Capsulitis, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effectiveness of virtual reality based exercises and conventional physical therapy on shoulder pain, mobility, functional ability and quality of life in adhesive capsulitis and to investigate whether it is superior to the control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- virtual reality based exercises, conventional physical therapy and home exercises program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18-65
- Clinical diagnosis of adhesive capsulitis
- Patients with loss of range of motion in a capsular pattern (external rotation >abduction > internal rotation)
- Participant signed informed consent
Who cannot join
- Surgery on the upper extremity or trunk
- Upper extremity injury in the last 6 months
- Injections in the shoulder area in the last 6 months
- Systemic or local infection of shoulder
- Uncontrolled hypertension
- Inability to cooperate VR
- Patient with malignancy
- Neurological disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahi Evran University
Kirşehir, City Centre, 40100
About this study
Official title: Comparison of the Effectiveness of Virtual Reality Based Exercises and Conventional Physical Therapy in the Treatment of Adhesive Capsulitis
The aim of this study is to evaluate the effectiveness of virtual reality based exercises and conventional physical therapy on shoulder pain, mobility, functional ability and quality of life in adhesive capsulitis and to investigate whether it is superior to the control group.
Read the detailed description
Adhesive capsulitis(AC) is an enigmatic condition characterized by painful, progressive and disabling loss of active and passive shoulder joint range of motion in multiple planes. Approximately 2% to 5% of adults between age 40 and 70 develop adhesive capsulitis with a greater occurrence in women and in individuals with thyroid disease or diabetes. AC is an arthrofibrosis involving the formation of excessive adhesions along the glenohumeral joint. It is a disease of unknown aetiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inflammation with fibroblast proliferation. Secondary adhesive capsulitis includes central nervous system problem, prolonged immobilisation of the arm, trauma or fracture, infectious diseases, etc. The progression of adhesive capsulitis is characterised by four stages, each stage showing a distinctive clinical presentation:
- Painful phase: lasts less than three months and is characterised by shoulder pain at night with preserved glenohumeral motion.
- Freezing phase: lasts three to nine months and is characterised by severe pain and stiffness in the glenohumeral joint.
- Frozen shoulder process: lasts nine to fourteen months and is characterised by loss of movement and pain in all directions at the end.
- Thawing phase: lasts fifteen to twenty-four months and is characterised by persistent stiffness, minimal pain, delayed recovery of shoulder movement.
Interventions for this pathology usually include physical therapy, nonsteroidal anti-inflammatory drug therapy, intra-articular steroid injections, distension arthrography and surgery. Physical therapy is the mainstay of treatment for patients with adhesive capsulitis. Conventional physical therapy consists of electrotherapy modalities such as TENS, Interferential current, Ultrasound, low intensity laser and exercises such as stretching exercises, Codman Exercise, Wand exercises and joint mobilisation and is used to control pain, increase flexibility and improve range of motion.
It is known that it takes a long time to achieve pain relief and a good improvement in ROM in adhesive capsulitis. This situation affects the quality of life of patients and creates a need for easily accessible treatment options that provide faster recovery.
One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation.
Different VR systems have been shown to be effective in individuals with kinesiophobia as well as stroke patients. Virtual reality guided exercise is a proven method already used in stroke, Parkinson's, cerebral palsy rehabilitation, vestibular rehabilitation and orthopaedic rehabilitation. However, there is limited data on its effectiveness in patients with adhesive capsulitis. This randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC.
The estimated number of volunteers expected to participate in the study was determined according to power analysis. The sample size of the study was determined by the GPower 3.1.9.7 program, and by using the finding in a similar study in the literature, it was used with 80% power and 5% margin of error to catch the medium effect size between dependent measurements. It was decided to work with a total of minimum 60 people, 20 in each group. Considering the patients who may be excluded from follow-up in the study, it is planned to start the study with 75 patients. The diagnosis of the disease will be made by history and clinical physical examination and no additional imaging technique will be required.
Patients will be randomly divided into 3 groups. They will be selected by simple random sampling using the closed envelope method, and then Group A (virtual reality + home exercise ), Group B (conventional therapy+ home exercise ) and Group C ( only home exercise ).
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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. They will play the registered games. These games will include purpose-oriented activities such as lying on the shelf 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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.
Individuals in the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks.
The home exercise programme will be demonstrated by the physiotherapist at the beginning of the treatment and all groups will be asked to perform these exercises at home. Patients will be given a chart and they will be asked to mark this chart on the day they exercise. The exercise compliance of the patients will be monitored with this chart.
Home exercises will be organised as pendulum (Codman), finger ladder, Wand exercises, towel stretch and will be given to the patient as a visually printed exercise sheet.
- Conditions
- Adhesive Capsulitis
- Being tested
- virtual reality based exercises, conventional physical therapy, home exercises program
- Keywords
- adhesive capsulitis, virtual reality, conventional physical therapy
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality based exercisesOther
play VR games
conventional physical therapyOther
streching and strengthening exercises
home exercises programOther
home exercises
| Study group | Role | What they receive |
|---|---|---|
| VR group | Active comparator | VR-based exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. They will play the registered games. These games will include purpose-oriented activities such as lying on the shelf and using bilaterally, which are intended to use the upper extremities of individuals with AC in daily life. Receives: Other: virtual reality based exercises; Other: home exercises program |
| Conventional group | Active comparator | 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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study. Receives: Other: conventional physical therapy; Other: home exercises program |
| Control group | Other | In the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks. Receives: Other: home exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Measured: 0( baseline)
Visual analog scale
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Measured: 3th week
Visual analog scale
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Measured: 12th week
Range of Motion
Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.
Measured: 0( baseline)
Range of Motion
Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.
Measured: 3th week
Range of Motion
Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.
Measured: 12th week
Secondary outcomes (9)
Shoulder Pain and Disability Index (SPADI)
SPADI is a scale consisting of a total of 13 questions with 2 subscales: pain and disability. Total and all sub-parameter scores are evaluated on a 0-100 scale. A high score indicates increased pain and impaired shoulder function.
Measured: 0( baseline)
Shoulder Pain and Disability Index (SPADI)
SPADI is a scale consisting of a total of 13 questions with 2 subscales: pain and disability. Total and all sub-parameter scores are evaluated on a 0-100 scale. A high score indicates increased pain and impaired shoulder function.
Measured: 3th week
Shoulder Pain and Disability Index (SPADI)
SPADI is a scale consisting of a total of 13 questions with 2 subscales: pain and disability. Total and all sub-parameter scores are evaluated on a 0-100 scale. A high score indicates increased pain and impaired shoulder function.
Measured: 12th week
Modified Constant-Murley Score
Modified Constant-Murley Score includes four parameters: pain, activities of daily living (ADL), active ROM and strength. The total score is evaluated on a 0-100 point scale by summing all sub-parameters. A low score reflects increased pain and impaired shoulder function for both sub-parameters and total score.
Measured: 0( baseline)
Modified Constant-Murley Score
Modified Constant-Murley Score includes four parameters: pain, activities of daily living (ADL), active ROM and strength. The total score is evaluated on a 0-100 point scale by summing all sub-parameters. A low score reflects increased pain and impaired shoulder function for both sub-parameters and total score.
Measured: 3th week
Modified Constant-Murley Score
Modified Constant-Murley Score includes four parameters: pain, activities of daily living (ADL), active ROM and strength. The total score is evaluated on a 0-100 point scale by summing all sub-parameters. A low score reflects increased pain and impaired shoulder function for both sub-parameters and total score.
Measured: 12th week
SF-36
Short-form health survey 36 (SF-36) contains 36 items that are used to evaluate the quality of life of patients with chronic pain. It measures eight different domains that address physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life). This assessment will be performed at pre-treatment, after 3 weeks of treatment and 12-week follow-up.
Measured: 0( baseline)
SF-36
Short-form health survey 36 (SF-36) contains 36 items that are used to evaluate the quality of life of patients with chronic pain. It measures eight different domains that address physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life). This assessment will be performed at pre-treatment, after 3 weeks of treatment and 12-week follow-up.
Measured: 3th week
SF-36
Short-form health survey 36 (SF-36) contains 36 items that are used to evaluate the quality of life of patients with chronic pain. It measures eight different domains that address physical functioning, physical role limitation, pain, general health, vitality, social functioning, emotional role limitation, and mental health. The score of each domain ranges from 0 (worse quality of life) to 100 (best quality of life). This assessment will be performed at pre-treatment, after 3 weeks of treatment and 12-week follow-up.
Measured: 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start15 Jan 2024
- Primary completion28 Sep 2024
- Study completion28 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly divided into 3 groups. They will be selected by simple random sampling using the closed envelope method. In the first group, will be included in a VR-based exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. In the second group, 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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. In the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Cigdem Karacay, Kirsehir Ahi Evran Universitesi
- Investigators
- Basak Cigdem KARACAY, assist prof, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201325
- Sponsor's protocol ID
- 2023-19/146
- Status last verified
- May 2026
- First submitted
- 30 Dec 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participant data (IPD) will not available to other researchers.
Publications
Sveistrup H, McComas J, Thornton M, Marshall S, Finestone H, McCormick A, Babulic K, Mayhew A. Experimental studies of virtual reality-delivered compared to conventional exercise programs for rehabilitation. Cyberpsychol Behav. 2003 Jun;6(3):245-9. doi: 10.1089/109493103322011524.
PubMed 12855079Lee SH, Yeh SC, Chan RC, Chen S, Yang G, Zheng LR. Motor Ingredients Derived from a Wearable Sensor-Based Virtual Reality System for Frozen Shoulder Rehabilitation. Biomed Res Int. 2016;2016:7075464. doi: 10.1155/2016/7075464. Epub 2016 Aug 23.
PubMed 27642600Gumaa M, Rehan Youssef A. Is Virtual Reality Effective in Orthopedic Rehabilitation? A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1304-1325. doi: 10.1093/ptj/pzz093.
PubMed 31343702
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Virtual Reality Based Exercises and Conventional Physical Therapy in the Treatment of Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06201325
- Acronym / sponsor ID
- 2023-19/146
- Conditions
- Adhesive Capsulitis
- Keywords
- adhesive capsulitis, virtual reality, conventional physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 28 Sep 2024 (actual)
- Study completion
- 28 Dec 2024 (actual)
- First posted
- 11 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effectiveness of virtual reality based exercises and conventional physical therapy on shoulder pain, mobility, functional ability and quality of life in adhesive capsulitis and to investigate whether it is superior to the control group.
Detailed description
Adhesive capsulitis(AC) is an enigmatic condition characterized by painful, progressive and disabling loss of active and passive shoulder joint range of motion in multiple planes. Approximately 2% to 5% of adults between age 40 and 70 develop adhesive capsulitis with a greater occurrence in women and in individuals with thyroid disease or diabetes. AC is an arthrofibrosis involving the formation of excessive adhesions along the glenohumeral joint. It is a disease of unknown aetiology and is classified as primary and secondary. Primary adhesive capsulitis includes cases of idiopathic origin resulting from chronic inflammation with fibroblast proliferation. Secondary adhesive capsulitis includes central nervous system problem, prolonged immobilisation of the arm, trauma or fracture, infectious diseases, etc. The progression of adhesive capsulitis is characterised by four stages, each stage showing a distinctive clinical presentation:
- Painful phase: lasts less than three months and is characterised by shoulder pain at night with preserved glenohumeral motion.
- Freezing phase: lasts three to nine months and is characterised by severe pain and stiffness in the glenohumeral joint.
- Frozen shoulder process: lasts nine to fourteen months and is characterised by loss of movement and pain in all directions at the end.
- Thawing phase: lasts fifteen to twenty-four months and is characterised by persistent stiffness, minimal pain, delayed recovery of shoulder movement.
Interventions for this pathology usually include physical therapy, nonsteroidal anti-inflammatory drug therapy, intra-articular steroid injections, distension arthrography and surgery. Physical therapy is the mainstay of treatment for patients with adhesive capsulitis. Conventional physical therapy consists of electrotherapy modalities such as TENS, Interferential current, Ultrasound, low intensity laser and exercises such as stretching exercises, Codman Exercise, Wand exercises and joint mobilisation and is used to control pain, increase flexibility and improve range of motion.
It is known that it takes a long time to achieve pain relief and a good improvement in ROM in adhesive capsulitis. This situation affects the quality of life of patients and creates a need for easily accessible treatment options that provide faster recovery.
One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation.
Different VR systems have been shown to be effective in individuals with kinesiophobia as well as stroke patients. Virtual reality guided exercise is a proven method already used in stroke, Parkinson's, cerebral palsy rehabilitation, vestibular rehabilitation and orthopaedic rehabilitation. However, there is limited data on its effectiveness in patients with adhesive capsulitis. This randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC.
The estimated number of volunteers expected to participate in the study was determined according to power analysis. The sample size of the study was determined by the GPower 3.1.9.7 program, and by using the finding in a similar study in the literature, it was used with 80% power and 5% margin of error to catch the medium effect size between dependent measurements. It was decided to work with a total of minimum 60 people, 20 in each group. Considering the patients who may be excluded from follow-up in the study, it is planned to start the study with 75 patients. The diagnosis of the disease will be made by history and clinical physical examination and no additional imaging technique will be required.
Patients will be randomly divided into 3 groups. They will be selected by simple random sampling using the closed envelope method, and then Group A (virtual reality + home exercise ), Group B (conventional therapy+ home exercise ) and Group C ( only home exercise ).
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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. They will play the registered games. These games will include purpose-oriented activities such as lying on the shelf 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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study.
Individuals in the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks.
The home exercise programme will be demonstrated by the physiotherapist at the beginning of the treatment and all groups will be asked to perform these exercises at home. Patients will be given a chart and they will be asked to mark this chart on the day they exercise. The exercise compliance of the patients will be monitored with this chart.
Home exercises will be organised as pendulum (Codman), finger ladder, Wand exercises, towel stretch and will be given to the patient as a visually printed exercise sheet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomly divided into 3 groups. They will be selected by simple random sampling using the closed envelope method. In the first group, will be included in a VR-based exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. In the second group, 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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. In the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks.
| Arm | Type | Receives |
|---|---|---|
| VR group | Active comparator | Other: virtual reality based exercises, Other: home exercises programVR-based exercise program for half an hour a day, 5 days a week for a total of 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. These individuals will use the Microsoft Kinect for Azure VR system in the virtual environment. They will play the registered games. These games will include purpose-oriented activities such as lying on the shelf and using bilaterally, which are intended to use the upper extremities of individuals with AC in daily life. |
| Conventional group | Active comparator | Other: conventional physical therapy, Other: home exercises programIndividuals 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 3 weeks, in addition to home exercise programs for half an hour a day, 5 days a week for a total of 3 weeks. The exercises will be performed by a physiotherapist working in the clinic and blind to the study. |
| Control group | Other | Other: home exercises programIn the third group, who will be included in the home exercise group, exercises will be taught to the patient and will be applied for half an hour a day, 5 days a week for a total of 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged between 18-65
- Clinical diagnosis of adhesive capsulitis
- Patients with loss of range of motion in a capsular pattern (external rotation >abduction > internal rotation)
- Participant signed informed consent
Key exclusion criteria (8 listed)
- Surgery on the upper extremity or trunk
- Upper extremity injury in the last 6 months
- Injections in the shoulder area in the last 6 months
- Systemic or local infection of shoulder
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality based exercisesplay VR games | Other | VR group |
| conventional physical therapystreching and strengthening exercises | Other | Conventional group |
| home exercises programhome exercises | Other | Control group, Conventional group, VR group |
Primary outcome
Visual analog scale
Time frame: 0( baseline)
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Visual analog scale
Time frame: 3th week
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Visual analog scale
Time frame: 12th week
The Visual Analog Scale is a pain rating scale with the numbers 0. Here 0 means 'no pain' and 10 means 'unbearable pain'. The participant will rate the pain according to the scale
Range of Motion
Time frame: 0( baseline)
Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.
Range of Motion
Time frame: 3th week
Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.
Range of Motion
Time frame: 12th week
Shoulder ROM is measured using a universal protractor(goniometer). Shoulder flection, extension, abduction, internal rotation and external rotation ranges are measured in the supine position.
9 secondary outcomes
Shoulder Pain and Disability Index (SPADI)
Time frame: 0( baseline)
Shoulder Pain and Disability Index (SPADI)
Time frame: 3th week
Shoulder Pain and Disability Index (SPADI)
Time frame: 12th week
Modified Constant-Murley Score
Time frame: 0( baseline)
Modified Constant-Murley Score
Time frame: 3th week
Modified Constant-Murley Score
Time frame: 12th week
SF-36
Time frame: 0( baseline)
SF-36
Time frame: 3th week
SF-36
Time frame: 12th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 12855079Sveistrup H, McComas J, Thornton M, Marshall S, Finestone H, McCormick A, Babulic K, Mayhew A. Experimental studies of virtual reality-delivered compared to conventional exercise programs for rehabilitation. Cyberpsychol Behav. 2003 Jun;6(3):245-9. doi: 10.1089/109493103322011524.
- Background: PubMed 27642600Lee SH, Yeh SC, Chan RC, Chen S, Yang G, Zheng LR. Motor Ingredients Derived from a Wearable Sensor-Based Virtual Reality System for Frozen Shoulder Rehabilitation. Biomed Res Int. 2016;2016:7075464. doi: 10.1155/2016/7075464. Epub 2016 Aug 23.
- Background: PubMed 31343702Gumaa M, Rehan Youssef A. Is Virtual Reality Effective in Orthopedic Rehabilitation? A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1304-1325. doi: 10.1093/ptj/pzz093.
- Individual participant dataSharing planned: No. participant data (IPD) will not available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Basak Cigdem KARACAY, assist prof principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality based exercises, conventional physical therapy and home exercises program in people with Adhesive Capsulitis, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog scale (time frame: 0( baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06201325, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.