AzTrials
AzTrials

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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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

Other trials in Turkey (Türkiye)

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:

  1. Painful phase: lasts less than three months and is characterised by shoulder pain at night with preserved glenohumeral motion.
  2. Freezing phase: lasts three to nine months and is characterised by severe pain and stiffness in the glenohumeral joint.
  3. Frozen shoulder process: lasts nine to fourteen months and is characterised by loss of movement and pain in all directions at the end.
  4. 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.

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 groups in NCT06201325
Study groupRoleWhat they receive
VR groupActive comparatorVR-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 groupActive comparatorIndividuals 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 groupOtherIn 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.

  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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)
  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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)

  8. 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

  9. 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.

  1. First posted11 Jan 2024
  2. Study start15 Jan 2024
  3. Primary completion28 Sep 2024
  4. Study completion28 Dec 2024

Resources

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)
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 12855079
  • Lee 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 27642600
  • Gumaa 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in