NCT07407088

Brief Summary

Rotator cuff lesions are among the most common causes of shoulder pain and functional limitation, often affecting daily living activities and quality of life. Conventional physiotherapy interventions such as therapeutic exercises and electrophysical agents are widely used; however, persistent pain, kinesiophobia, and functional disability may limit treatment outcomes. Virtual reality-supported task-oriented training has emerged as a promising rehabilitation approach by providing immersive, functional, and goal-directed activities that may enhance motor performance and psychosocial outcomes. The aim of this randomized controlled trial is to investigate the effects of virtual reality-supported task-oriented training added to conventional physiotherapy in individuals with rotator cuff lesions. Participants will be randomly allocated into two groups: a control group receiving conventional physiotherapy (therapeutic exercises and electrophysical agents) and an intervention group receiving virtual reality-supported task-oriented training in addition to conventional physiotherapy. Both groups will undergo treatment three times per week for six weeks, totaling 18 sessions. Outcome measures will include pain intensity at rest, during activity, and at night assessed by the Visual Analog Scale (VAS); grip strength measured by dynamometry; pinch strength measured by pinchmeter; upper extremity function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; shoulder pain and disability assessed by the Shoulder Pain and Disability Index (SPADI); kinesiophobia assessed by the Tampa Scale of Kinesiophobia; pain catastrophizing assessed by the Pain Catastrophizing Scale; and anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS). The findings of this study are expected to contribute to evidence-based rehabilitation strategies for individuals with rotator cuff lesions.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Feb 2026May 2026

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2026

Expected
Last Updated

April 13, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 6, 2026

Last Update Submit

April 8, 2026

Conditions

Keywords

Rotator cuff lesionsvirtual realitytask-oriented training

Outcome Measures

Primary Outcomes (1)

  • Upper extremity functionality

    The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to assess upper extremity functional disability. The DASH is a self-reported outcome measure consisting of 30 items that evaluate difficulty in performing physical activities and the severity of symptoms related to upper extremity disorders. Scores range from 0 to 100, with higher scores indicating greater disability.

    6 week

Secondary Outcomes (7)

  • Pain Intensity (Visual Analog Scale - VAS)

    6 week

  • Grip Strength

    6 week

  • Pinch Strength

    6 week

  • Disability

    6 week

  • Kinesiophobia

    6 week

  • +2 more secondary outcomes

Study Arms (2)

Control Group

EXPERIMENTAL

Participants allocated to the control group will receive conventional physiotherapy consisting of therapeutic exercises and electrophysical agents. The treatment program will be administered three times per week for six weeks, for a total of 18 sessions. Therapeutic exercises will focus on improving shoulder mobility, strength, and functional use of the upper extremity. Electrophysical agents will be applied as part of standard clinical practice to support pain management and tissue healing. No virtual reality-supported training will be provided to participants in this group.

Other: Conventional treatment

Virtual Reality-Supported Task-Oriented Training Group

EXPERIMENTAL

Participants allocated to the intervention group will receive virtual reality-supported task-oriented training in addition to conventional physiotherapy. Conventional physiotherapy will consist of therapeutic exercises and electrophysical agents and will be administered three times per week for six weeks, totaling 18 sessions. The virtual reality-supported task-oriented training will be delivered during the same treatment period and will include functional, goal-directed activities simulating activities of daily living, such as kitchen-related tasks, cleaning activities, and pushing and pulling movements. The virtual reality program will be performed using a virtual reality device and will be tailored to the participant's functional capacity and tolerance, with task difficulty progressively adjusted throughout the intervention period. The training aims to enhance shoulder function, upper extremity use, motor performance, and psychosocial outcomes by promoting active participation and

Other: Conventional treatmentOther: Virtual Reality-Supported Task-Oriented Training

Interventions

The treatment program will be administered three times per week for six weeks, for a total of 18 sessions. Therapeutic exercises will focus on improving shoulder mobility, strength, and functional use of the upper extremity. Electrophysical agents will be applied as part of standard clinical practice to support pain management and tissue healing.

Control GroupVirtual Reality-Supported Task-Oriented Training Group

he virtual reality-supported task-oriented training will be delivered during the same treatment period and will include functional, goal-directed activities simulating activities of daily living, such as kitchen-related tasks, cleaning activities, and pushing and pulling movements. The virtual reality program will be performed using a virtual reality device and will be tailored to the participant's functional capacity and tolerance, with task difficulty progressively adjusted throughout the intervention period. The training aims to enhance shoulder function, upper extremity use, motor performance, and psychosocial outcomes by promoting active participation and graded exposure to functional movements.

Virtual Reality-Supported Task-Oriented Training Group

Eligibility Criteria

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

You may qualify if:

  • Aged between 18 and 65 years
  • Diagnosed with a rotator cuff lesion confirmed by clinical examination and/or imaging methods (MRI or ultrasound)
  • Presence of shoulder pain and functional limitation for at least 3 months
  • Ability to actively use the affected upper extremity
  • Ability to understand and follow verbal instructions
  • Willingness to participate in the study and provide written informed consent

You may not qualify if:

  • History of shoulder surgery on the affected side
  • Full-thickness rotator cuff tear requiring surgical intervention
  • Presence of shoulder fracture, dislocation, or acute traumatic injury within the last 6 months
  • Neurological disorders affecting the upper extremity (e.g., stroke, multiple sclerosis, peripheral neuropathy)
  • Systemic inflammatory or rheumatologic diseases affecting the shoulder (e.g., rheumatoid arthritis)
  • Severe cervical spine pathology with referred shoulder pain
  • Severe visual, vestibular, or cognitive impairments that may limit participation in virtual reality training
  • Current participation in another structured shoulder rehabilitation program
  • Contraindications to physical therapy or virtual reality-based interventions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırşehir Ahi Evran University

Kırşehir, 40100, Turkey (Türkiye)

Location

Study Officials

  • Mehmet CANLI, Ph.D.

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

February 16, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 15, 2026

Last Updated

April 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations