- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07478835
VR-Assisted Rehabilitation in Partial Supraspinatus Tears
Effects of Virtual Reality-Assisted Rehabilitation on Pain, Kinesiophobia, Quality of Life, and Supraspinatus Tendon Thickness in Patients With Partial Supraspinatus Tears: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to investigate the effects of virtual reality-assisted rehabilitation on pain, kinesiophobia, quality of life, and supraspinatus tendon thickness in patients with partial supraspinatus tendon tears.
Partial supraspinatus tears are a common cause of shoulder pain and functional limitation, often leading to decreased quality of life and increased fear of movement. Virtual reality (VR) has emerged as an innovative rehabilitation tool that may enhance patient engagement and treatment adherence.
This study is designed as a randomized controlled trial to evaluate the effectiveness of virtual reality-assisted rehabilitation in patients with partial supraspinatus tendon tears.
Partial supraspinatus tendon tears are a common cause of shoulder pain and functional impairment, often associated with reduced range of motion, decreased quality of life, and increased kinesiophobia. Conventional rehabilitation approaches are widely used; however, patient adherence and engagement may be limited.
Participants diagnosed with partial supraspinatus tendon tears will be randomly allocated to either a virtual reality-assisted rehabilitation group or a conventional rehabilitation group. Both groups will receive a standardized physical therapy program including hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. In addition, participants in the virtual reality group will perform interactive, task-oriented exercises using virtual reality applications designed to enhance motivation and active participation. The control group will perform conventional therapeutic exercises targeting shoulder mobility, strength, and function.
All interventions will be applied over a structured treatment period under the supervision of a physiotherapist. Evaluations will be conducted at baseline and after completion of the intervention period.
This study aims to determine whether the integration of virtual reality into conventional rehabilitation provides additional clinical benefits in terms of pain reduction, functional improvement, and patient engagement in individuals with partial supraspinatus tendon tears.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Çorum, Turkey (Türkiye), 19000
- Hitit University Erol Olçok Research Hospital Physical Medicine and Rehabilitation Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Shoulder pain persisting for more than 4 weeks
- Diagnosis of partial supraspinatus tendon tear confirmed by shoulder magnetic resonance imaging
Exclusion Criteria:
- Received physiotherapy treatment within the previous 6 months
- Received shoulder injection within the previous 6 months
- History of tendon repair surgery
- Presence of communication or cognitive impairment
- Vertigo or vestibular disorders, or other conditions causing balance instability
- History of epilepsy or seizures
- Sensitivity to light
- Diagnosed psychiatric disorders (including anxiety disorders or claustrophobia)
- Any additional orthopedic condition affecting the same shoulder
- Pregnancy or breastfeeding
- Neurological, vascular, or cardiac disorders that may restrict functional capacity
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: virtual reality group
Participants in the experimental group received the same conventional treatment protocol and additionally performed virtual reality (VR)-assisted exercises.
A Meta Quest Pro VR headset (Meta Platforms Inc.) was used to provide an immersive virtual environment during the intervention.
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Participants in the experimental group received the same conventional physiotherapy program as the control group and additionally performed virtual reality (VR)-assisted exercises.
A Meta Quest Pro VR headset (Meta Platforms Inc.) was used to provide an immersive virtual environment during the intervention.
The system provides high-resolution optics, a wide field of view, and six degrees of freedom (6DoF) motion tracking, allowing accurate tracking of upper extremity movements.
VR-based exercises were designed to promote repetitive shoulder and upper limb movements through interactive, task-oriented activities within a three-dimensional virtual environment.
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Active Comparator: Control Group
participants performed a set of therapeutic exercises after the same conventional treatment protocol
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After completion of the standard physiotherapy modalities, participants performed a set of therapeutic exercises aimed at improving shoulder mobility and coordination of the shoulder girdle muscles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity measured by the Numeric Rating Scale (NRS)
Time Frame: Baseline and after 3 weeks of treatment
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Pain intensity was evaluated using an 11-point Numeric Rating Scale (NRS).
Participants were asked to indicate the severity of their shoulder pain by selecting a number between 0 and 10, where 0 represented the absence of pain and 10 represented the most severe pain imaginable.Measurements were obtained both at rest and during shoulder movement, and the reported values were recorded as the participants' pain scores
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Baseline and after 3 weeks of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Passive range of motion (ROM) of the affected shoulder
Time Frame: Baseline and after 3 weeks of treatment
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shoulder ROM, including flexion, extension, abduction, internal rotation, and external rotation, was measured using a universal goniometer (Saehan Goniometer) within the tolerable range of motion
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Baseline and after 3 weeks of treatment
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Shoulder pain and functional impairment were assessed using the Shoulder Pain and Disability Index (SPADI)
Time Frame: Baseline and after 3 weeks of treatment
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SPADI, a 13-item questionnaire consisting of pain (5 items) and disability (8 items) subscales.
Each item is scored on a 0-10 scale, and total scores are expressed as percentages ranging from 0 to 100, with higher scores indicating greater pain and disability
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Baseline and after 3 weeks of treatment
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Health-related quality of life was evaluated using the Short Form-36 (SF-36) questionnaire
Time Frame: Baseline and after 3 weeks of treatment
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SF-36 questionnaire, which includes 36 items across eight domains: physical functioning, role limitations due to physical problems, bodily pain, general health perception, vitality, social functioning, role emotional limitations, and mental health.
Domain scores range from 0 to 100, with higher scores indicating better health status.
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Baseline and after 3 weeks of treatment
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Fear of movement and reinjury was assessed using the Tampa Scale of Kinesiophobia (TAMPA)
Time Frame: Baseline and after 3 weeks of treatment
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TAMPA, a 17-item questionnaire scored on a four-point Likert scale.
Total scores range from 17 to 68, with higher scores reflecting greater kinesiophobia
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Baseline and after 3 weeks of treatment
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The supraspinatus tendon thickness was measured using Ultrasonography(USG)
Time Frame: Baseline and after 3 weeks of treatment
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The supraspinatus tendon thickness was measured using USG with the shoulder positioned in extension and external rotation, and the hand placed on the gluteal region.
Tendon thickness was recorded according to the EURO-MUSCULUS standardized protocol.
All ultrasonographic measurements were performed by the same experienced physician.
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Baseline and after 3 weeks of treatment
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Collaborators and Investigators
Sponsor
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-144
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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