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Rotator Cuff SyndromeNCT06228625

Comparison of Rehabilitative Game Exercise and Body Awareness Therapy in Rotator Cuff Syndrome

A study testing Conventional Exercise Group, Body Awareness Training Group and Rehabilitative Game Exercise Group in people with Rotator Cuff Syndrome, run by Medipol University 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 syndrome is one of the most common problems in the shoulder, starting as acute tendinopathy and progressing to partial and full thickness tears. Shoulder pain causes a decrease in shoulder joint movement, joint position sense, upper extremity function and quality of life. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Rotator Cuff Syndrome
What is being tested?
Conventional Exercise Group, Body Awareness Training Group and Rehabilitative Game Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Dec 2024to 25 Aug 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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of partial supraspinatus rupture by an Orthopedics and Traumatology specialist placement.
  • Unilateral shoulder pain,
  • Not having been involved in any physiotherapy program before due to shoulder problem,
  • Body mass index (BMI) ≤ 30 kg/m²
  • Cooperation of individuals

Who cannot join

  • Having had previous shoulder surgery,
  • Having received local corticosteroid injection/corticosteroid treatment in the last three months,
  • Presence of a disease that will affect the neurological, cardiac, systemic, cognitive and visual systems,

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Özlem Görgülü Göksu

    Istanbul, Beykoz, 34815

Other trials in Turkey (Türkiye)

About this study

Rotator cuff syndrome is one of the most common problems in the shoulder, starting as acute tendinopathy and progressing to partial and full thickness tears. Shoulder pain causes a decrease in shoulder joint movement, joint position sense, upper extremity function and quality of life. Among the most commonly used conservative treatment methods; Joint range of motion exercises, stretching exercises, strengthening exercises, mobilization and electrotherapy method are included.

Nowadays, with the widespread use of technology in rehabilitation, video-based games have begun to be used for rehabilitative purposes in addition to conservative approaches. Although the effectiveness of video-based games has been extensively studied in diseases such as cerebral palsy, stroke and parkinsonism, there are a limited number of studies in the field of orthopedic rehabilitation, especially in shoulder rehabilitation.

Read more

Basic body awareness therapy is used to treat chronic musculoskeletal-related painful conditions. In the literature, basic body awareness therapy has been studied in patient groups such as mental health, stroke patient groups, chronic musculoskeletal problems, chronic waist and neck pain, scoliosis and knee osteoarthritis. Studies have shown that the TBFT method provides improvements in individuals' body awareness, mobility in daily living activities, health-related quality of life, body image and pain intensity. However, no studies have been found in which basic body awareness therapy was used in the field of shoulder rehabilitation.

Our study aims to compare the effectiveness of a rehabilitative game exercise program and body awareness training in terms of pain, joint range of motion, shoulder functionality, proprioception, body awareness, shoulder-related quality of life, kinesiophobia and patient satisfaction in individuals with Rotator cuff syndrome.

Read the detailed description

It is one of the most common problems in the shoulder, which begins as acute tendinopathy in rotator cuff surgery and can progress to partial and full thickness tears. The most commonly affected muscle is supraspinatus and infraspinatus, followed in second place.

The shoulder joint is an important and complex joint in terms of both mobility and stability. Having a wide joint range of motion makes stabilization of this joint difficult. Passive (bone, capsule, ligament) and active (muscles) structures play an important role in ensuring stability. The stabilization mechanism is under the control of the central nervous system. The sensorimotor system is responsible for all proprioceptive information, motor or neuromuscular responses and central integration, and plays a role in maintaining the balance of static and dynamic stabilizers around the joint.Proprioceptive sensory input is one of the most important structures of the sensorimotor system. Insufficiency in proprioceptive sense is one of the factors that predispose to injuries, and studies have shown that proprioceptive deficit is present in common pathologies of the shoulder such as shoulder instability, impingement syndrome, rotator cuff injuries, adhesive capsulitis and osteoarthritis. The first symptom that usually occurs in rotator cuff injuries is pain, and its incidence increases significantly with age.Shoulder pain and increasing shoulder joint movement limitation cause a decrease in shoulder active joint position sense (proprioception), upper extremity function and quality of life. Exercise prescription in general; It focuses on increasing the range of motion of the glenohumeral joint and the flexibility of the muscles in the region, providing scapular control and increasing the muscle strength of the shoulder area. Among the most commonly used conservative treatment methods; Joint range of motion exercises, stretching exercises, strengthening exercises, mobilization and electrotherapy method are included.

Today, with the widespread use of technology in rehabilitation, video-based games have begun to be used for rehabilitative purposes in addition to conservative approaches.

Products such as Nintendo Wii, Microsoft Kinect and Fizyosoft can be given as examples of video-based games. Video-based game exercise programs are defined as a combination of physical movements and games designed to increase the physical activity level and functionality of individuals. Although the effectiveness of video-based games in neurorehabilitation has been extensively studied in diseases such as cerebral palsy, stroke and parkinsonism, there are a limited number of studies in the field of orthopedic rehabilitation, especially in the treatment protocols of patients with rotator cuff injury and subacromial impingment syndrome.

Basic Body Awareness Therapy is an existential treatment approach targeting mind-body integrity that is frequently used in the rehabilitation of patients with psychiatric disorders and chronic musculoskeletal problems. Basic body awareness therapy is used in the treatment of painful conditions related to the chronic musculoskeletal system. In the literature, it has been seen that basic body awareness therapy has been studied in patient groups such as mental health, stroke patient groups, chronic musculoskeletal problems, chronic waist and neck pain, scoliosis and knee osteoarthritis. It has been shown in the studies examined that the basic body awareness therapy method, which provides integration of mind-body integrity, provides improvement in individuals' body awareness, mobility in daily living activities, health-related quality of life, body image and pain intensity findings. However, no studies have been found in which basic body awareness therapy was used in the field of shoulder rehabilitation.

The aim of our study is to compare the effectiveness of a rehabilitative game exercise program and body awareness training in terms of pain, joint range of motion, shoulder functionality, proprioception, body awareness, shoulder-related quality of life, kinesiophobia and patient satisfaction in individuals with Rotator cuff syndrome. In addition to conventional methods, the rehabilitative game exercise programWe predict that body awareness training will bring a different perspective to the field of shoulder rehabilitation.

Being tested
Conventional Exercise Group, Body Awareness Training Group, Rehabilitative Game Exercise Group
Keywords
Body Awareness, Body İmage, Exergame, Rotator cuff, Videogames

What participants receive

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

  • Conventional Exercise GroupBehavioural

    • Wand Exercises (Shoulder flexion, abduction, extension, external, internal rotation *10 rep.)
    • Codmann Exercises (In each direction with front-back, right-left, clockwise and counterclockwise movements *10 rep.)
    • Finger Ladder (flexion and abduction directions * 10 rep.)
    • Strengthening Exercises (Shoulder flexion, abduction, extension, external, internal rotation *10 rep).
    • Posterior, anterior and inferior capsule stretching ,pectoral muscle stretching * 10 rep.
  • Body Awareness Training GroupBehavioural

    • Supine: Body scan, contraction-relaxation exercises, strength recovery exercises combined with sound, stretching exercises, cross and star stretching.
    • Sitting: Teaching the correct body alignment while sitting, exercise to restore the correct body alignment,
    • Standing: Weight bearing exercises within stability limits, midline descent and elevation exercises, midline rotation exercises, wave motion, pushing movement combined with oblique weight bearing.
  • Rehabilitative Game Exercise GroupBehavioural

    • Cone Knockout: The game requires touching the cones that appear alternately on the right and left within one minute.
    • Space Pong: It is required to play by hitting the ball with the right or left hand. It requires only upper extremity use and has seven abductions. Scoring is based on the ball hit.
    • Reaction: It is a game that requires touching the green dots that appear on the screen within a certain period. The points received vary depending on the speed of touching the dots. Points are lost when the red dots are touched.
    • Whack A Male: The player has 3 rights, and it requires using the upper extremity to hit the moles that come out of 5 holes at different times. A mole with a thorn on its head and a bomb should not be hit. Before the spiny mole emerges, a red light appears in the hole where it will emerge.
Study groups in NCT06228625
Study groupRoleWhat they receive
Control GroupActive comparatorConventional exercise training will be given to the control group for 6 weeks, 5 days a week, for 45 minutes. Conventional exercises will be applied to this group under the supervision of a physiotherapist for 5 days in our unit.
Receives: Behavioral: Conventional Exercise Group
Body Awareness Training GroupExperimentalAfter the first evaluation, the training group will be given basic body awareness exercise training for 6 weeks, 2 days a week, for 45 minutes. This group will be given to basic body awareness exercises under the supervision of a physiotherapist for 2 days in our unit. Individuals in this group will be applied basic body awareness exercisea program in addition to conventional exercises.
Receives: Behavioral: Body Awareness Training Group
Rehabilitative Game Exercise GroupExperimentalIndividuals in this group will be applied a video-based rehabilitative game exercise program in addition to conventional exercises. A digital game network called 'Active Arcade Game' will be used for rehabilitative game exercises. Rehabilitative Game Exercise Group for 6 weeks, 2 days a week, for 45 minutes. This group will be given to basic body awareness exercises under the supervision of a physiotherapist for 2 days in our unit.
Receives: Behavioral: Rehabilitative Game Exercise Group

What is being measured

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

  1. Pain Severity rated their feelings of pain on the line by themselves, thereby quantifying the pain.sual Analogue Scale

    Participants pain intensities ranged from "0" (no pain) to "10" (unbearable pain) to 10 cm will be evaluated with the Visual Pain Scale. The pain intensity of the participants before and after the treatment was evaluated at rest and during activity.

    Measured: Baseline and after 6 weeks

  2. Pain threshold

    Algometer is a device used to evaluate the pain threshold, thanks to the pressure it applies. While increasing the pressure using the algometer, persons are asked to indicate at the first point where they feel pain or discomfort. The first point of discomfort is defined as the pain threshold of the individual.The first point of discomfort is defined as the individual's pain threshold point. When evaluating the pain thresholds of people participating in the study, their most sensitive areas will be taken as reference. Measurements will be repeated 3 times and their average will be taken.

    Measured: Baseline and after 6 weeks

  3. Evaluation of joint range of motion

    Baseline digital Absolute + Axis goniometer device will be used. Flexion, extension, abduction, internal and external rotation range of motion of the shoulder joint will be evaluated in degrees. For each joint range of motion value, 3 consecutive measurements will be taken and the average value will be recorded.

    Measured: Baseline and after 6 weeks

  4. Evaluation of Joint Position Sense

    Active angle repetition test for shoulder joint position sense will be performed with the smartphone goniometer application. 40° and 100° elevation angles will be used in the scapular plan, which are frequently preferred in the literature. For the evaluation, first of all, the participants will be asked to passively perform a 40° elevation movement on one shoulder in the scapular plane while their eyes are open and they will be asked to learn this angle. Then, the participants will raise their shoulders to 40° elevation 3 more times with their eyes closed, wait 10 seconds to teach this angle, and then return to the starting position.The test will be repeated 6 times and individuals will rest for 5 seconds between each repetition. All applications were repeated for a shoulder elevation angle of 100°. The test was performed at 40° and 100° shoulder elevation on both shoulders.

    Measured: Baseline and after 6 weeks

Secondary outcomes (6)
  1. Rotator Cuff Quality of Life

    It is a questionnaire that evaluates the quality of life in rotator cuff injuries. It is a disease-specific questionnaire and is distinctive in assessing quality of life. It is a questionnaire consisting of 34 questions and 5 subparameters that evaluates the physical symptoms of the disease, work activities, daily living activities, social and emotional status. Each question is calculated out of 100 points and the total score is expressed as a percentage.

    Measured: Baseline and after 6 weeks

  2. American Shoulder and Elbow Surgeons (ASES)

    American Shoulder and Elbow Surgeons (ASES) created the ASES questionnaire in order to develop a standardized method for evaluating shoulder function. The goal was to design a questionnaire that was easy to use, assessed function, and was entirely based on patient self-evaluation. The ASES score totals 100 points and allocates 50 points for measuring function and 50 points for pain.

    Measured: Baseline and after 6 weeks

  3. Body Awareness Questionnaire

    The body awareness questionnaire is a 18 item scale, with the total scale score calculated as a sum of the items. Items are scored on a 1-7 scale, with the total scale score calculated as a sum of the items. The questions with asterisks are reverse scored. This means that for example, if someone scored 1 it would now be a score of 5.

    Measured: Baseline and after 6 weeks

  4. Body Image Survey (BIA)

    BIA was used to measure the patients' level of satisfaction with their body image. BIA consists of a person's body parts or functions.It is a scale that determines satisfaction. It was shown in the study by Hovardaoğlu et al. that the scale is valid and reliable in Turkish.

    Measured: Baseline and after 6 weeks

  5. The Tampa Scale for Kinesiophobia (TSK)

    The Tampa Scale for Kinesiophobia (TSK) is a self-report questionnaire that is used to assess an individual's fear of movement or re-injury. The TSK consists of 17 items that ask respondents to rate their level of agreement with statements related to the fear of movement or re-injury. A high score from the scale indicates a high level of kinesiophobia.

    Measured: Baseline and after 6 weeks

  6. Patient Satisfaction Evaluation

    How much of the applied treatment meets the patients' expectations can be simply asked by asking "what is the percentage of your recovery rate with the applied treatment?" and "What is the percentage of the treatment applied that meets your expectations?" It was evaluated with two questions. Participants' answers were recorded as percentage values.

    Measured: After 6 weeks

Timeline

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

  1. First posted29 Jan 2024
  2. Study start2 Dec 2024
  3. Primary completion25 Aug 2026
  4. Study completion25 Aug 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
Randomize Controlled Double Blind Study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06228625
Sponsor's protocol ID
IMUogorgulugoksu1
Status last verified
Aug 2026
First submitted
18 Jan 2024
Last updated
25 Aug 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 Exercise Group, Body Awareness Training Group and Rehabilitative Game Exercise Group in people with Rotator Cuff Syndrome, run by Medipol University 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 5 inclusion and 3 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 25 Aug 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?

Pain Severity rated their feelings of pain on the line by themselves, thereby quantifying the pain.sual Analogue Scale (time frame: Baseline and after 6 weeks). The study lists 4 primary outcomes in all. 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 25 Aug 2026.

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