NCT07478835

Brief Summary

This randomized controlled trial aims to investigate the effects of virtual reality-assisted rehabilitation in patients with partial supraspinatus tendon tears. Virtual reality has emerged as a promising tool to enhance patient engagement and improve rehabilitation outcomes in musculoskeletal disorders; however, evidence in this patient population remains limited. Participants will be assigned to either a virtual reality-assisted rehabilitation group or a conventional rehabilitation group. Both groups will receive a structured physical therapy program, while the intervention group will additionally perform virtual reality-based exercises. The study will evaluate the potential benefits of virtual reality in improving clinical outcomes compared to conventional rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

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

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

March 12, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

Virtual RealityKinesiophobiaExercise TherapyRehabilitationRotator cuff

Outcome Measures

Primary Outcomes (1)

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

    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

    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 functional impairment were assessed using the Shoulder Pain and Disability Index (SPADI)

    Baseline and after 3 weeks of treatment

  • Health-related quality of life was evaluated using the Short Form-36 (SF-36) questionnaire

    Baseline and after 3 weeks of treatment

  • Fear of movement and reinjury was assessed using the Tampa Scale of Kinesiophobia (TAMPA)

    Baseline and after 3 weeks of treatment

  • The supraspinatus tendon thickness was measured using Ultrasonography(USG)

    Baseline and after 3 weeks of treatment

Study Arms (2)

virtual reality group

EXPERIMENTAL

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.

Behavioral: VR-assisted rehabilitation program

Control Group

ACTIVE COMPARATOR

participants performed a set of therapeutic exercises after the same conventional treatment protocol

Behavioral: Conventional shoulder exercise program

Interventions

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.

virtual reality group

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

Control Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University Erol Olçok Research Hospital Physical Medicine and Rehabilitation Clinic

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 assigned in a 1:1 ratio to either the virtual reality-assisted rehabilitation group or the conventional exercise group. Both groups received the same standard physiotherapy modalities, while the experimental group additionally performed VR-based exercises.
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

March 23, 2026

Record last verified: 2026-03

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