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Rotator Cuff LesionsNCT07407088

Effect of Virtual Reality-Supported Task-Oriented Training in Individuals With Rotator Cuff Lesions

A study testing Conventional treatment and Virtual Reality-Supported Task-Oriented Training in people with Rotator Cuff Lesions, run by Kirsehir Ahi Evran Universitesi 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

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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rotator Cuff Lesions
What is being tested?
Conventional treatment and Virtual Reality-Supported Task-Oriented Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 Feb 2026to 30 May 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

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Kırşehir Ahi Evran University

    Kırşehir, 40100

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Rotator cuff lesions are a leading cause of shoulder pain, reduced range of motion, muscle weakness, and functional limitations, significantly affecting activities of daily living. In addition to physical impairments, individuals with rotator cuff lesions often experience psychosocial factors such as kinesiophobia, pain catastrophizing, anxiety, and depression, which may negatively influence rehabilitation outcomes. Conventional physiotherapy interventions, including therapeutic exercises and electrophysical agents, are commonly prescribed; however, these approaches may not adequately address functional task performance and psychosocial components of recovery.

Task-oriented training focuses on practicing meaningful, goal-directed activities that closely resemble real-life tasks, thereby facilitating motor learning and functional improvement. Recently, virtual reality-supported rehabilitation has gained increasing attention as it enables the simulation of functional environments, provides multisensory feedback, and enhances patient engagement and motivation. Virtual reality-supported task-oriented training may offer additional benefits by integrating physical and cognitive demands while reducing fear of movement through graded exposure to functional tasks.

This randomized controlled trial aims to investigate the effectiveness of virtual reality-supported task-oriented training when added to conventional physiotherapy in individuals with rotator cuff lesions. Eligible participants will be randomly assigned to either a control group or an intervention group using a random allocation method. The control group will receive conventional physiotherapy consisting of therapeutic exercises and electrophysical agents. The intervention group will receive the same conventional physiotherapy program plus virtual reality-supported task-oriented training. Both interventions will be administered three times per week for six weeks, resulting in a total of 18 treatment sessions.

The virtual reality-supported task-oriented training program will include functional tasks designed to simulate activities of daily living, such as kitchen-related activities, cleaning tasks, and pushing and pulling movements. These tasks will be performed using a virtual reality device and will be progressively adapted according to the participant's functional level and tolerance. The training is intended to promote upper extremity use, improve shoulder function, and address psychosocial factors associated with pain and movement avoidance.

The results of this study will provide evidence regarding the effectiveness of virtual reality-supported task-oriented training as an adjunct to conventional physiotherapy in improving pain, strength, functional outcomes, and psychosocial factors in individuals with rotator cuff lesions. The findings may help guide clinical decision-making and the development of innovative, functionally oriented rehabilitation programs.

Being tested
Conventional treatment, Virtual Reality-Supported Task-Oriented Training
Keywords
Rotator cuff lesions, virtual reality, task-oriented training

What participants receive

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

  • Conventional treatmentOther

    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.

  • Virtual Reality-Supported Task-Oriented TrainingOther

    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.

Study groups in NCT07407088
Study groupRoleWhat they receive
Control GroupExperimentalParticipants 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.
Receives: Other: Conventional treatment
Virtual Reality-Supported Task-Oriented Training GroupExperimentalParticipants 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
Receives: Other: Conventional treatment; Other: Virtual Reality-Supported Task-Oriented Training

What is being measured

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

  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.

    Measured: 6 week

Secondary outcomes (7)
  1. Pain Intensity (Visual Analog Scale - VAS)

    Pain intensity at rest, during activity, and at night will be assessed using the Visual Analog Scale (VAS). The VAS consists of a 10-cm horizontal line representing pain intensity, where 0 indicates "no pain" and 10 indicates "worst imaginable pain."

    Measured: 6 week

  2. Grip Strength

    Grip strength of the affected upper extremity will be measured using a hand dynamometer. Measurements will be recorded in kilograms, and higher values indicate greater grip strength.

    Measured: 6 week

  3. Pinch Strength

    Pinch strength of the affected upper extremity will be assessed using a pinchmeter. Measurements will be recorded in kilograms, with higher values indicating greater pinch strength.

    Measured: 6 week

  4. Disability

    The Shoulder Pain and Disability Index (SPADI) will be used to assess shoulder-related pain and functional disability. The questionnaire consists of pain and disability subscales, with total scores ranging from 0 to 100; higher scores indicate greater pain and disability.

    Measured: 6 week

  5. Kinesiophobia

    Kinesiophobia will be evaluated using the Tampa Scale of Kinesiophobia, which measures fear of movement and re-injury related to pain. Higher scores indicate greater levels of kinesiophobia.

    Measured: 6 week

  6. Pain Catastrophizing

    Pain catastrophizing will be assessed using the Pain Catastrophizing Scale, which evaluates exaggerated negative cognitive and emotional responses to pain. Higher scores reflect greater pain catastrophizing.

    Measured: 6 week

  7. Anxiety and Depression

    Psychological status will be assessed using the Hospital Anxiety and Depression Scale (HADS), which consists of anxiety and depression subscales. Higher scores indicate greater levels of anxiety and depressive symptoms.

    Measured: 6 week

Timeline

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

  1. First posted12 Feb 2026
  2. Study start16 Feb 2026
  3. Primary completion25 May 2026
  4. Study completion30 May 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
randomized controlled trials
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07407088
Sponsor's protocol ID
43834581758'
Status last verified
Feb 2026
First submitted
6 Feb 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Conventional treatment and Virtual Reality-Supported Task-Oriented Training in people with Rotator Cuff Lesions, run by Kirsehir Ahi Evran Universitesi 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 6 inclusion and 9 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 5 Jun 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?

Upper extremity functionality (time frame: 6 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Jun 2026.

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