NCT07478835

Brief Summary

This randomized controlled trial investigated the effects of virtual reality-assisted rehabilitation in patients with partial supraspinatus tendon tears. Partial supraspinatus tears are a common cause of shoulder pain, functional limitation, restricted range of motion, and fear of movement. Conservative rehabilitation is commonly used as first-line treatment, while evidence regarding immersive virtual reality rehabilitation in this patient population remains limited. Participants were randomly allocated to either a virtual reality-assisted rehabilitation group or a conventional rehabilitation group. Both groups received the same physical therapy modalities, including hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. The control group subsequently performed conventional therapeutic shoulder exercises, whereas the virtual reality group performed approximately equal-duration immersive VR-based exercises instead of the conventional exercise component. Outcomes included pain, shoulder range of motion, disability, kinesiophobia, health-related quality of life, and supraspinatus tendon thickness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

12 months

First QC Date

March 12, 2026

Last Update Submit

September 10, 2026

Conditions

Keywords

Virtual RealityKinesiophobiaExercise TherapyRehabilitationRotator cuff

Outcome Measures

Primary Outcomes (1)

  • Pain intensity measured by the Numeric Rating Scale (NRS)

    Pain intensity at rest and during shoulder movement was assessed separately using an 11-point Numeric Rating Scale, ranging from 0 (no pain) to 10 (the worst pain imaginable). Higher scores indicated greater pain intensity.

    Baseline and after 3 weeks of treatment

Secondary Outcomes (5)

  • Passive range of motion (ROM) of the affected shoulder

    Baseline and after 3 weeks of treatment

  • Shoulder pain and disability measured using the Shoulder Pain and Disability Index (SPADI)

    Baseline and after 3 weeks of treatment

  • Health-related quality of life measured using the Short Form-36 (SF-36)

    Baseline and after 3 weeks of treatment

  • Kinesiophobia measured using the Tampa Scale of Kinesiophobia

    Baseline and after 3 weeks of treatment

  • Supraspinatus tendon thickness measured using ultrasonography (USG)

    Baseline and after 3 weeks of treatment

Study Arms (2)

virtual reality group

EXPERIMENTAL

Participants received the same physical therapy modalities as the control group, consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. They subsequently performed approximately 30 minutes of immersive virtual reality-based upper-extremity exercise using a Meta Quest Pro headset instead of the conventional therapeutic exercise component. The virtual reality exercise was therefore a replacement rather than an additional treatment.

Behavioral: VR-assisted rehabilitation program

Control Group

ACTIVE COMPARATOR

Participants received physical therapy modalities consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. They subsequently performed approximately 30 minutes of supervised conventional therapeutic shoulder exercises targeting shoulder mobility, stretching, strengthening, and scapular stabilization.

Behavioral: Conventional shoulder exercise program

Interventions

Participants received physical therapy modalities consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation. They subsequently performed approximately 30 minutes of immersive virtual reality-based upper-extremity exercise using a Meta Quest Pro headset instead of the conventional therapeutic shoulder exercise component. The virtual reality activities involved repetitive, task-oriented shoulder and upper-extremity movements within an interactive three-dimensional environment. The intervention was delivered five days per week for three weeks, for a total of 15 sessions.

virtual reality group

After receiving physical therapy modalities consisting of hot pack, therapeutic ultrasound, and transcutaneous electrical nerve stimulation, participants performed approximately 30 minutes of supervised conventional therapeutic shoulder exercise. The program included scapular mobilization; stretching exercises for shoulder flexion, abduction, internal rotation, and external rotation; and strengthening exercises for the shoulder and scapular stabilizer muscles. Exercises were performed in three sets of 10 repetitions. The intervention was delivered five days per week for three weeks, for a total of 15 sessions.

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 to 65 years
  • Shoulder pain persisting for more than four weeks
  • Partial supraspinatus tendon tear confirmed by shoulder magnetic resonance imaging

You may not qualify if:

  • Physiotherapy treatment within the previous six months
  • Shoulder injection within the previous six months
  • History of tendon repair surgery
  • Communication or cognitive impairment
  • Vertigo, vestibular disorder, or another condition causing balance instability
  • History of epilepsy or seizures
  • Photosensitivity
  • Diagnosed psychiatric condition, including an anxiety disorder or claustrophobia
  • Additional orthopedic condition affecting the same shoulder
  • Neurological, vascular, or cardiac disorder restricting functional capacity
  • Pregnancy or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University Erol Olçok Research Hospital Physical Medicine and Rehabilitation Clinic

Çorum, Çorum, 19000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder PainKinesiophobia

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly allocated in a 1:1 ratio to two parallel groups. Both groups received the same standard physical therapy modalities. The control group subsequently performed approximately 30 minutes of conventional therapeutic shoulder exercise, whereas the experimental group performed approximately 30 minutes of immersive virtual reality-based exercise instead of the conventional exercise component.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 12, 2026

First Posted

March 18, 2026

Study Start

January 1, 2025

Primary Completion

December 20, 2025

Study Completion

December 20, 2025

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional regulations and the absence of participant consent for public data sharing.

Locations