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Adhesive CapsulitisNCT07236229

The Effects of Immersive Virtual Reality in Patients With Grade 1-2 Adhesive Capsulitis

A study testing Conventional Physiotherapy Group and Immersive Virtual Reality-Based Exercise Therapy in people with Adhesive Capsulitis and Virtual Reality, run by Bahçeşehir University 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
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Trial summary

Adhesive capsulitis (frozen shoulder) is a complex condition characterized by inflammation, fibrosis, and restriction of movement in the shoulder capsule, significantly limiting an individual's participation in daily living activities. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Adhesive Capsulitis, Virtual Reality, Sleep
What is being tested?
Conventional Physiotherapy Group and Immersive Virtual Reality-Based Exercise Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Nov 2025to 1 Apr 2026
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

  • Diagnosed with adhesive capsulitis by a doctor
  • Classified as Grade 1-2 adhesive capsulitis
  • Receiving physiotherapy for adhesive capsulitis for the first time
  • Aged between 18 and 64 years
  • Suitable for using a VR headset

Who cannot join

  • Previous history of physiotherapy
  • Presence of any mental disorder
  • Recent surgery or any shoulder condition (e.g., fractures around the shoulder region) that contraindicates shoulder mobilization
  • History of receiving injections

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kanuni Sultan Suleyman Training and Research Hospital

    Küçükçekmece, Istanbul, 34519

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Immersive Virtual Reality-Based Exercise Therapy on Pain, Functionality, Sleep, and Cognitive Functions in Patients With Grade 1-2 Adhesive Capsulitis

Adhesive capsulitis (frozen shoulder) is a complex condition characterized by inflammation, fibrosis, and restriction of movement in the shoulder capsule, significantly limiting an individual's participation in daily living activities. It is most commonly observed in individuals aged between 40 and 60 years, and its treatment frequently involves approaches such as manual therapy, exercise, corticosteroid injections, and electrotherapy. However, these conventional methods may be limited by factors such as lack of motivation, pain-related avoidance behavior, and poor treatment adherence.

Today, immersive virtual reality technologies introduce a new dimension to rehabilitation by gamifying exercise, providing sensory feedback, and enabling graded exposure through mechanisms such as distraction and engagement. They also enhance motivation and compliance with exercise programs. Studies in the literature have reported that virtual reality-based exercise is an effective method for reducing pain levels in patients diagnosed with frozen shoulder.

However, only a limited number of studies have specifically examined the effects of immersive virtual reality in patients with adhesive capsulitis. To date, no study has investigated the impact of immersive virtual reality interventions on sleep and cognitive functions in these patients. Furthermore, the combined effect of patient education, home exercise programs, and immersive virtual reality therapy has not yet been explored. For these reasons, the present study aims to investigate the effects of immersive virtual reality-based exercise therapy on pain, functionality, sleep, and cognitive functions in patients with Grade 1-2 adhesive capsulitis.

Read the detailed description

Our study was designed as a single-center, randomized, controlled, prospective trial aiming to compare the effectiveness of immersive virtual reality-based exercise therapy and conventional therapy in patients diagnosed with Grade 1-2 adhesive capsulitis.Patients who consent to participate will be randomly assigned to two groups:

Intervention Group (n = 15): Patient education + Home exercise program + Immersive virtual reality-based exercise therapy

Control Group (n = 15): Patient education + Home exercise program + Conventional exercise therapy

Intervention Process All participants will receive treatment twice a week for six weeks, with each session lasting 30 minutes. The initial assessment will be conducted before the first session, and the final assessment will take place at the end of the sixth week. Both the immersive virtual reality-based exercise group and the conventional exercise group will receive patient education. The educational content aims to describe the natural course of the disease, promote activity modification to encourage functional and pain-free range of motion, and adjust stretching intensity to suit the patient's current level.

Patient education will be delivered once, face-to-face, for 30 minutes before the interventions begin, and it will cover five main topics:

Introduction to the Disease: General information about adhesive capsulitis. Pain Mechanisms and Perception: Education on pain pathways and interpretation. Encouragement of Activity: Emphasis on safely using the shoulder within pain-free limits during daily life activities.

Preparation for Treatment: Explanation that the virtual reality-based therapy will be conducted in a gamified and motivating environment, while the control group will receive traditional physiotherapy methods.

Exercise Adherence and Follow-up: Emphasis on the importance of active participation for treatment success and the monitoring of progress through pre- and post-assessments.

Hanchard et al. strongly supported the implementation of patient education and home exercise programs in individuals with adhesive capsulitis.

Home Exercise Program In addition to patient education, both groups will perform the same home exercise program. Participants will carry out the exercises at home for 30 minutes a day, five days a week, over a six-week period (on non-intervention days). The home exercise program will be progressive and similar to the conventional therapy applied by the physiotherapist. It will include range of motion (ROM) exercises, stretching exercises, and pendulum exercises.

Immersive Virtual Reality-Based Exercise Group In the immersive virtual reality group, the Oculus Quest 2 headset will be used with the Guided Tai Chi and Reach Shoulder Health applications, both applied progressively. Oculus Quest 2 is a virtual reality headset used for therapeutic purposes in shoulder rehabilitation and has been previously applied in patients with adhesive capsulitis.

The Template for Intervention Description and Replication (TIDieR) checklist and guide were used to describe the intervention protocols in detail, ensuring reproducibility and clinical applicability. Both the immersive virtual reality and conventional exercise intervention programs were developed in accordance with TIDieR recommendations.

The Reach Shoulder Health program is an interactive virtual reality application that gamifies shoulder rehabilitation exercises. It includes a variety of modules designed to enhance upper extremity range of motion, coordination, and muscle activation-particularly beneficial for patients with restricted shoulder mobility such as adhesive capsulitis. The program progressively trains shoulder mobilization, target-reaching, hand-eye coordination, range of motion, and muscle strengthening around the shoulder. Its game modules, including Firefly Assessment, Space Gunner, Bullseye, Tube Trouble, Star Beams, and Power Pop, are structured to be both entertaining and therapeutic, incorporating multiple levels to increase patient motivation and treatment adherence. Participants will progress through five levels each week over the six-week period.

The Guided Tai Chi application is another virtual reality program designed to enhance shoulder mobility and provide pain-free movement experiences while reducing anxiety and improving motivation in patients with adhesive capsulitis. The exercises in this application will also be progressively increased in difficulty across beginner, intermediate, and advanced levels throughout the six-week intervention.

Conventional Exercise Group Participants in the conventional exercise group will receive a 30-minute exercise session twice a week for six weeks. The program will include range of motion exercises, pendulum exercises, finger ladder activities, stretching, and strengthening exercises. All exercises will be applied progressively, increasing in intensity over time.

Evaluation All participants will be assessed for pain levels, shoulder range of motion, ability to perform daily living activities, sleep quality, and cognitive functions using valid and reliable measurement tools before and after the interventions. Assessments will be conducted at the first session and at the end of the sixth week, and pre- and post-intervention results will be compared.

Being tested
Conventional Physiotherapy Group, Immersive Virtual Reality-Based Exercise Therapy
Keywords
Adhesive Capsulitis, Virtual Reality, Sleep, Pain, Cognition
Medical subject headings
Bursitis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Physiotherapy GroupOther

    In the conventional exercise group, participants will perform range of motion exercises, pendulum exercises, finger ladder exercises, stretching, and strengthening exercises. The traditional exercise therapy will be administered twice a week for six weeks, with each session lasting 30 minutes.

    In addition, both groups will receive identical patient education and home exercise programs. Patient education will be delivered face-to-face for 30 minutes at the beginning of the intervention. The home exercise program will be performed progressively at home on non-intervention days, five days per week.

  • Immersive Virtual Reality-Based Exercise TherapyOther

    Patients in the immersive virtual reality-based exercise group will participate in the exercise program using the Oculus Quest 2 device. Sessions will be conducted twice a week for six weeks, each lasting 30 minutes. Two different virtual reality applications, Reach Shoulder Health and Guided Tai Chi, will be administered to the patients in this group.

    In addition, both groups will receive identical patient education and home exercise programs. Patient education will be delivered face-to-face for 30 minutes at the beginning of the intervention. The home exercise program will be performed progressively at home on non-intervention days, five days per week.

Study groups in NCT07236229
Study groupRoleWhat they receive
Immersive Virtual Reality-Based Exercise TherapyExperimentalParticipants in this group will receive immersive virtual reality-based exercise therapy using Oculus Quest 2 applications (Guided Tai Chi and Reach Shoulder Health) for 6 weeks, 2 sessions per week.
Receives: Other: Immersive Virtual Reality-Based Exercise Therapy
Conventional Physiotherapy GroupActive comparatorParticipants in this group will receive standard physiotherapy exercises for adhesive capsulitis including ROM, stretching, and strengthening for 6 weeks, 2 sessions per week.
Receives: Other: Conventional Physiotherapy Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain intensity measured by the Visual Analog Scale (VAS)

    The VAS assesses perceived shoulder pain intensity on a 10-cm line from "no pain" to "worst pain imaginable.

    Measured: Baseline and at the end of the 6-week intervention period

Secondary outcomes (9)
  1. Shoulder Function (Shoulder Pain and Disability Index - SPADI)

    Shoulder pain and disability will be assessed with the SPADI, which evaluates pain and functional limitation on a 0-100 scale, where higher scores indicate greater impairment.

    Measured: Baseline and at the end of the 6-week intervention period

  2. Shoulder Range of Motion (ROM)

    Shoulder joint mobility (flexion, extension, abduction, adduction, internal and external rotation) will be measured in degrees using a goniometer to evaluate changes in movement capacity.

    Measured: Baseline and at the end of the 6-week intervention period

  3. Pain Catastrophizing (Pain Catastrophizing Scale - PCS)

    Catastrophic thinking related to pain will be assessed using the PCS, which measures rumination, magnification, and helplessness. Total scores range from 0 to 52, with higher scores indicating greater levels of pain catastrophizing.

    Measured: Baseline and at the end of the 6-week intervention period

  4. Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)

    The PSQI assesses sleep quality over the past month across seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Component scores (0-3) are summed to yield a global score (0-21), with higher scores indicating poorer sleep quality (commonly, >5 suggests poor sleep).

    Measured: Baseline and at the end of the 6-week intervention period

  5. Digit Span Test

    The Digit Span Test (DST) will be used to assess attention, short-term memory, and processing speed. It consists of two parts: Digit Span Forward (DSF) and Digit Span Backward (DSB). The total score ranges from 0 to 17 (maximum DSF = 9, DSB = 8). Higher scores indicate better verbal attention and short-term memory performance.

    Measured: Baseline and at the end of the 6-week intervention period

  6. Wisconsin Card Sorting Test

    Wisconsin Card Sorting Test (WCST) will be used to assess executive functions, including cognitive flexibility, abstract reasoning, and problem-solving ability. The primary outcome measures will include total errors, perseverative errors, and non-perseverative errors. Scores range from 0 to 128, with fewer errors indicating better executive functioning.

    Measured: Baseline and at the end of the 6-week intervention period

  7. Benton Visual Retention Test

    Benton Visual Retention Test (BVRT) will be used to assess short-term visual memory, visual perception, and visuoconstructive abilities. The version used in this study will be Form F, which will include 15 stimulus cards and 15 corresponding multiple-choice response cards.

    Scores will be calculated as the number of correct responses, with a possible range of 0 to 15. Higher scores will indicate better visual memory performance.

    Measured: Baseline and at the end of the 6-week intervention period

  8. Virtual Reality Discomfort Questionnaire

    Virtual Reality Discomfort Questionnaire includes symptoms such as fatigue, eyestrain, headache, and dizziness. Each item is rated on a 4-point Likert-type scale ranging from 0 (never) to 3 (very often). The total score is obtained by summing all item scores and then converting it into a percentage for interpretation. Higher scores indicate a greater level of discomfort associated with virtual reality use.

    Measured: At the end of the first Virtual Reality session

  9. Virtual Reality Satisfaction Questionnaire

    Virtual Reality Satisfaction Questionnaire will be used to provide descriptive data to understand the contribution of the virtual reality experience to the therapeutic process and patient comfort. The questionnaire consists of a total of 10 items under four subdimensions: ease of use, visual/auditory experience, engagement/interest, and overall satisfaction. Each item will be rated on a 4-point Likert-type scale ranging from 0 (never) to 3 (very often). The total score will be obtained by summing all item scores and converting the result into a percentage for interpretation. Higher scores will indicate greater patient satisfaction with the virtual reality experience.

    Measured: At the end of the first Virtual Reality session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start28 Nov 2025
  3. Primary completion11 Jan 2026
  4. Study completion1 Apr 2026

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 divided into two groups using the stratified randomization method. The first group will be the immersive virtual reality-based exercise group (n=17), and the second group will be the conventional exercise group (n=17).
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07236229
Sponsor's protocol ID
BahcesehirU_H_AC-VR_01
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Sharing individual raw data is not appropriate due to ethical committee approval requirements and personal data protection regulations.

Publications

  • Mena-Del Horno S, Balasch-Bernat M, Louw A, Luque-Suarez A, Rodriguez-Brazzarola P, Navarro-Ledesma S, Murillo C, Duenas L, Lluch E. Is there any benefit of adding a central nervous system-focused intervention to a manual therapy and home stretching program for people with frozen shoulder? A randomized controlled trial. J Shoulder Elbow Surg. 2023 Jul;32(7):1401-1411. doi: 10.1016/j.jse.2023.02.134. Epub 2023 Mar 29.

    PubMed 37001795
  • Mertens MG, Meert L, Struyf F, Schwank A, Meeus M. Exercise Therapy Is Effective for Improvement in Range of Motion, Function, and Pain in Patients With Frozen Shoulder: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2022 May;103(5):998-1012.e14. doi: 10.1016/j.apmr.2021.07.806. Epub 2021 Aug 21.

    PubMed 34425089
  • Hanchard NCA, Goodchild L, Brealey SD, Lamb SE, Rangan A. Physiotherapy for primary frozen shoulder in secondary care: Developing and implementing stand-alone and post operative protocols for UK FROST and inferences for wider practice. Physiotherapy. 2020 Jun;107:150-160. doi: 10.1016/j.physio.2019.07.004. Epub 2019 Jul 19.

    PubMed 32026815
  • Demir OB, Kablanoglu S, Sari PN, Alyanak B, Taskin Yilmaz F, Dursun E. Effects of virtual reality exercise on pain, joint motion, and quality of life in patients with frozen shoulder: a randomized controlled study. Physiother Theory Pract. 2025 Jul;41(7):1435-1446. doi: 10.1080/09593985.2024.2443027. Epub 2024 Dec 19.

    PubMed 39700302
  • Ozlu A, Ustundag S, Bulut Ozkaya D, Menekseoglu AK. Effect of Exergame on Pain, Function, and Quality of Life in Shoulder Impingement Syndrome: A Prospective Randomized Controlled Study. Games Health J. 2024 Apr;13(2):109-119. doi: 10.1089/g4h.2023.0108. Epub 2024 Feb 23.

    PubMed 38394299

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Physiotherapy Group and Immersive Virtual Reality-Based Exercise Therapy in people with Adhesive Capsulitis and Virtual Reality, run by Bahçeşehir University 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 5 inclusion and 4 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 8 Oct 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?

Pain intensity measured by the Visual Analog Scale (VAS) (time frame: Baseline and at the end of the 6-week intervention period). 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 NCT07236229, which also lists 5 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 8 Oct 2026.

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