Rotator Cuff InjuriesNCT06599567
Graded Motor Imagery and Biofeedback in Rotator Cuff Injury
A study testing Traditional therapy, Graded motor imagery and Nintendo Wİİ in people with Rotator Cuff Injuries and Rotator Cuff Injury, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This study aims to compare the effectiveness of conventional therapy, Graded Motor Imagery (GMI), and Nintendo Wii-based biofeedback therapy in patients with rotator cuff injuries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rotator Cuff Injuries, Rotator Cuff Injury, Rotator Cuff Syndrome
- What is being tested?
- Traditional therapy, Graded motor imagery and Nintendo Wİİ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2024to 25 May 2025
- 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
- Between the ages of 18-65
- A rotator cuff injury was diagnosed and conservative treatment was decided
- Volunteer for research
- People who can read, write and understand Turkish
Who cannot join
- Having neurological findings of cervical origin
- An additional different orthopedic problem in the same shoulder (Full thickness rotator cuff tear, adhesive capsulitis and glenohumeral instability)
- Uncooperative or mental problem
- Neurological, vascular and cardiac problem that limits function
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University- Cerrahpaşa
Istanbul, Istanbul, 34519
About this study
Official title: THE EFFECT OF GRADED MOTOR IMAGERY AND NINTENDO WII-BASED BIOFEEDBACK TECHNIQUES ON ROTATOR CUFF PATHOLOGIES
Purpose: This study aims to compare the effectiveness of conventional therapy, Graded Motor Imagery (GMI), and Nintendo Wii-based biofeedback therapy in patients with rotator cuff injuries. The goal is to evaluate the impact of these three methods on pain management, range of motion (ROM), patient satisfaction, and functional performance.
Hypotheses:
Read more
There is no significant difference in pain management between conventional therapy, GMI, and Wii-based biofeedback therapy.
There is no significant difference in shoulder ROM between the three therapies. There is no significant difference in patient satisfaction among the therapies. There is no significant difference in functional performance improvement between the therapies.
Methods: A randomized, double-blind, controlled trial will be conducted with 36 patients with rotator cuff injuries. They will be randomly assigned to one of three groups and undergo 6 weeks of treatment. Pain, ROM, and functional performance will be assessed pre- and post-treatment. Data will be analyzed using ANOVA.
Potential Outcomes/Significance: The study may show that innovative approaches like GMI and Wii-based biofeedback therapy are effective treatment options. Results could contribute to developing new strategies for treating chronic pain and motor dysfunctions.
Read the detailed description
Study Title: Comparative Effectiveness of Conventional Therapy, Graded Motor Imagery (GMI), and Nintendo Wii-Based Biofeedback Therapy in Rotator Cuff Injuries
Purpose: The primary aim of this study is to compare the effectiveness of three different therapeutic interventions-conventional therapy, Graded Motor Imagery (GMI), and Nintendo Wii-based biofeedback therapy-in managing rotator cuff injuries. The study will evaluate the impact of these therapies on key outcomes including pain management, shoulder range of motion (ROM), patient satisfaction, and functional performance. By comparing these methods, the study seeks to determine which therapy offers the best overall benefit for patients with rotator cuff injuries.
Hypotheses:
Hypothesis 1: There is no significant difference in pain management between conventional therapy, GMI, and Wii-based biofeedback therapy.
Alternative Hypothesis (H1): Significant differences in pain management exist among these therapies.
Hypothesis 2: There is no significant difference in shoulder ROM between conventional therapy, GMI, and Wii-based biofeedback therapy.
Alternative Hypothesis (H1): Significant differences in shoulder ROM exist among these therapies.
Hypothesis 3: There is no significant difference in patient satisfaction among conventional therapy, GMI, and Wii-based biofeedback therapy.
Alternative Hypothesis (H1): Significant differences in patient satisfaction exist among these therapies.
Hypothesis 4: There is no significant difference in functional performance improvement between conventional therapy, GMI, and Wii-based biofeedback therapy.
Alternative Hypothesis (H1): Significant differences in functional performance improvement exist among these therapies.
Methods: This study will use a randomized, double-blind, controlled trial design. A total of 36 patients diagnosed with rotator cuff injuries will be randomly assigned to one of three treatment groups: conventional therapy, Graded Motor Imagery (GMI), or Nintendo Wii-based biofeedback therapy. Each group will undergo their respective treatment for a duration of 6 weeks. The effectiveness of each treatment will be assessed through measurements taken before and after the intervention. Pain levels, shoulder ROM, and functional performance will be evaluated using standardized assessment tools. Statistical analysis will be performed using ANOVA to compare outcomes across the three treatment groups.
Potential Outcomes/Significance: The results of this study have the potential to highlight the effectiveness of innovative therapies like GMI and Wii-based biofeedback therapy in the treatment of rotator cuff injuries. If these methods are found to be more effective than conventional therapy, they could represent valuable additions to treatment options for patients suffering from chronic pain and motor dysfunctions. The findings may contribute to the development of new, evidence-based strategies for managing rotator cuff injuries and improving patient outcomes in rehabilitation settings.
- Being tested
- Traditional therapy, Graded motor imagery, Nintendo Wİİ
- Keywords
- graded motor imagery, pain, shoulder joint, rehabilitation, rotator cuff injuries
- Medical subject headings
- Rotator Cuff Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional therapyOther
Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises
Graded motor imageryOther
Cold-Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, graded motor imagery training (body right-left discrimination exercise, imagining the movement and exercising the opposite limb in front of the mirror).
Nintendo WİİOther
Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, games involving your relevant shoulder such as boxing and bowling on the Nintendo Wii game console.
| Study group | Role | What they receive |
|---|---|---|
| Traditional therapy | Active comparator | Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises Receives: Other: Traditional therapy |
| Graded motor imagery | Active comparator | Cold-Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, graded motor imagery training (body right-left discrimination exercise, imagining the movement and exercising the opposite limb in front of the mirror). Receives: Other: Graded motor imagery |
| Nintendo Wİİ | Active comparator | Cold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, games involving your relevant shoulder such as boxing and bowling on the Nintendo Wii game console. Receives: Other: Nintendo Wİİ |
What is being measured
The primary outcome is the main question the study is designed to answer.
quickDASH short form
QuickDASH will be used to assess upper extremity functional limitations and symptoms in patients with rotator cuff injuries Scoring: QuickDASH consists of 11 questions, each rated on a scale from 1 to 5. The final score is calculated between 0 (no difficulty) and 100 (extreme difficulty)
Measured: From enrollment to the end of treatment at 6 weeks
Secondary outcomes (5)
Shoulder Pain
NPRS (Numeric Pain Rating Scale) is a self-reported scale used to assess the intensity of pain. If you are conducting research on shoulder and arm injuries, such as rotator cuff pathologies, you can use this scale to evaluate the patients\' pain levels.
NPRS is an 11-point scale where the patient rates their pain from 0 (no pain) to 10 (worst possible pain)
Measured: From enrollment to the end of treatment at 6 weeks
Range of motion
ROM (Range of Motion) is an objective measurement used to assess the mobility and flexibility of joints. If you are conducting research on shoulder injuries such as rotator cuff pathologies, you can use ROM assessments to evaluate improvements in joint mobility.
ROM is usually measured in degrees using a goniometer. Specific movements like shoulder flexion, extension, abduction, and rotation are assessed.
Measured: From enrollment to the end of treatment at 6 weeks
Kinesiophobia
The Tampa Scale of Kinesiophobia (TSK) is a self-reported questionnaire used to assess the fear of movement or re-injury in patients. If you are conducting research on shoulder injuries such as rotator cuff pathologies, you can use this scale to evaluate patients' fear of movement and its impact on recovery.
The TSK consists of 17 items, each rated on a 4-point Likert scale. The total score ranges from 17 to 68, with higher scores indicating greater fear of movement.
Measured: From enrollment to the end of treatment at 6 weeks
Global Rating of Change
The Global Rating of Change (GRC) is a self-reported scale used to measure a patient\'s perception of overall improvement or deterioration over time. If you are conducting research on rotator cuff injuries, you can use the GRC to evaluate patients\' subjective assessment of their progress.
The GRC is typically measured on a scale ranging from -5 (a very great deal worse) to +5 (a very great deal better), with 0 indicating no change.
Measured: From enrollment to the end of treatment at 6 weeks
Lateralization
The Recognise app is a tool used to assess lateralization, which involves identifying left and right body parts to measure motor imagery and cortical representation. If you are conducting research on rotator cuff injuries, you can use this app to evaluate patients\' ability to recognize and distinguish between left and right body parts, which can be important in assessing changes in cortical representation and motor imagery.
Measured: From enrollment to the end of treatment at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Sep 2024
- Primary completion25 May 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1. st group traditional therapy 2. nd group : traditional therapy and graded motor imagery 3. rd group traditional therapy and biofeedback training with nintendo wii
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cansu ERCAN, Istanbul University - Cerrahpasa
- Investigators
- Cansu Ercan, Principal investigator, Unaffiliated"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599567
- Sponsor's protocol ID
- 8Z3KqXp1
- Status last verified
- Jul 2025
- First submitted
- 12 Sep 2024
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD, all IPD that underlie results in a publication
Publications
Suso-Marti L, La Touche R, Angulo-Diaz-Parreno S, Cuenca-Martinez F. Effectiveness of motor imagery and action observation training on musculoskeletal pain intensity: A systematic review and meta-analysis. Eur J Pain. 2020 May;24(5):886-901. doi: 10.1002/ejp.1540. Epub 2020 Feb 20.
PubMed 32031724Hoyek N, Di Rienzo F, Collet C, Hoyek F, Guillot A. The therapeutic role of motor imagery on the functional rehabilitation of a stage II shoulder impingement syndrome. Disabil Rehabil. 2014;36(13):1113-9. doi: 10.3109/09638288.2013.833309. Epub 2014 Feb 28.
PubMed 24575717
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF GRADED MOTOR IMAGERY AND NINTENDO WII-BASED BIOFEEDBACK TECHNIQUES ON ROTATOR CUFF PATHOLOGIES
- ClinicalTrials.gov ID
- NCT06599567
- Acronym / sponsor ID
- 8Z3KqXp1
- Keywords
- graded motor imagery, pain, shoulder joint, rehabilitation, rotator cuff injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This study aims to compare the effectiveness of conventional therapy, Graded Motor Imagery (GMI), and Nintendo Wii-based biofeedback therapy in patients with rotator cuff injuries. The goal is to evaluate the impact of these three methods on pain management, range of motion (ROM), patient satisfaction, and functional performance.
Hypotheses:
There is no significant difference in pain management between conventional therapy, GMI, and Wii-based biofeedback therapy.
There is no significant difference in shoulder ROM between the three therapies. There is no significant difference in patient satisfaction among the therapies. There is no significant difference in functional performance improvement between the therapies.
Methods: A randomized, double-blind, controlled trial will be conducted with 36 patients with rotator cuff injuries. They will be randomly assigned to one of three groups and undergo 6 weeks of treatment. Pain, ROM, and functional performance will be assessed pre- and post-treatment. Data will be analyzed using ANOVA.
Potential Outcomes/Significance: The study may show that innovative approaches like GMI and Wii-based biofeedback therapy are effective treatment options. Results could contribute to developing new strategies for treating chronic pain and motor dysfunctions.
Detailed description
Study Title: Comparative Effectiveness of Conventional Therapy, Graded Motor Imagery (GMI), and Nintendo Wii-Based Biofeedback Therapy in Rotator Cuff Injuries
Purpose: The primary aim of this study is to compare the effectiveness of three different therapeutic interventions-conventional therapy, Graded Motor Imagery (GMI), and Nintendo Wii-based biofeedback therapy-in managing rotator cuff injuries. The study will evaluate the impact of these therapies on key outcomes including pain management, shoulder range of motion (ROM), patient satisfaction, and functional performance. By comparing these methods, the study seeks to determine which therapy offers the best overall benefit for patients with rotator cuff injuries.
Hypotheses:
Hypothesis 1: There is no significant difference in pain management between conventional therapy, GMI, and Wii-based biofeedback therapy.
Alternative Hypothesis (H1): Significant differences in pain management exist among these therapies.
Hypothesis 2: There is no significant difference in shoulder ROM between conventional therapy, GMI, and Wii-based biofeedback therapy.
Alternative Hypothesis (H1): Significant differences in shoulder ROM exist among these therapies.
Hypothesis 3: There is no significant difference in patient satisfaction among conventional therapy, GMI, and Wii-based biofeedback therapy.
Alternative Hypothesis (H1): Significant differences in patient satisfaction exist among these therapies.
Hypothesis 4: There is no significant difference in functional performance improvement between conventional therapy, GMI, and Wii-based biofeedback therapy.
Alternative Hypothesis (H1): Significant differences in functional performance improvement exist among these therapies.
Methods: This study will use a randomized, double-blind, controlled trial design. A total of 36 patients diagnosed with rotator cuff injuries will be randomly assigned to one of three treatment groups: conventional therapy, Graded Motor Imagery (GMI), or Nintendo Wii-based biofeedback therapy. Each group will undergo their respective treatment for a duration of 6 weeks. The effectiveness of each treatment will be assessed through measurements taken before and after the intervention. Pain levels, shoulder ROM, and functional performance will be evaluated using standardized assessment tools. Statistical analysis will be performed using ANOVA to compare outcomes across the three treatment groups.
Potential Outcomes/Significance: The results of this study have the potential to highlight the effectiveness of innovative therapies like GMI and Wii-based biofeedback therapy in the treatment of rotator cuff injuries. If these methods are found to be more effective than conventional therapy, they could represent valuable additions to treatment options for patients suffering from chronic pain and motor dysfunctions. The findings may contribute to the development of new, evidence-based strategies for managing rotator cuff injuries and improving patient outcomes in rehabilitation settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- 1. st group traditional therapy 2. nd group : traditional therapy and graded motor imagery 3. rd group traditional therapy and biofeedback training with nintendo wii
| Arm | Type | Receives |
|---|---|---|
| Traditional therapy | Active comparator | Other: Traditional therapyCold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises |
| Graded motor imagery | Active comparator | Other: Graded motor imageryCold-Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, graded motor imagery training (body right-left discrimination exercise, imagining the movement and exercising the opposite limb in front of the mirror). |
| Nintendo Wİİ | Active comparator | Other: Nintendo WİİCold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, games involving your relevant shoulder such as boxing and bowling on the Nintendo Wii game console. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between the ages of 18-65
- A rotator cuff injury was diagnosed and conservative treatment was decided
- Volunteer for research
- People who can read, write and understand Turkish
Key exclusion criteria (4 listed)
- Having neurological findings of cervical origin
- An additional different orthopedic problem in the same shoulder (Full thickness rotator cuff tear, adhesive capsulitis and glenohumeral instability)
- Uncooperative or mental problem
- Neurological, vascular and cardiac problem that limits function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional therapyCold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises | Other | Traditional therapy |
| Graded motor imageryCold-Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, graded motor imagery training (body right-left discrimination exercise, imagining the movement and exercising the opposite limb in front of the mirror). | Other | Graded motor imagery |
| Nintendo WİİCold - Hot pack applications, TENS device application, which is a pain-relieving electrotherapy agent, therapeutic exercises, games involving your relevant shoulder such as boxing and bowling on the Nintendo Wii game console. | Other | Nintendo Wİİ |
Primary outcome
quickDASH short form
Time frame: From enrollment to the end of treatment at 6 weeks
QuickDASH will be used to assess upper extremity functional limitations and symptoms in patients with rotator cuff injuries Scoring: QuickDASH consists of 11 questions, each rated on a scale from 1 to 5. The final score is calculated between 0 (no difficulty) and 100 (extreme difficulty)
5 secondary outcomes
Shoulder Pain
Time frame: From enrollment to the end of treatment at 6 weeks
Range of motion
Time frame: From enrollment to the end of treatment at 6 weeks
Kinesiophobia
Time frame: From enrollment to the end of treatment at 6 weeks
Global Rating of Change
Time frame: From enrollment to the end of treatment at 6 weeks
Lateralization
Time frame: From enrollment to the end of treatment at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 32031724Suso-Marti L, La Touche R, Angulo-Diaz-Parreno S, Cuenca-Martinez F. Effectiveness of motor imagery and action observation training on musculoskeletal pain intensity: A systematic review and meta-analysis. Eur J Pain. 2020 May;24(5):886-901. doi: 10.1002/ejp.1540. Epub 2020 Feb 20.
- Background: PubMed 24575717Hoyek N, Di Rienzo F, Collet C, Hoyek F, Guillot A. The therapeutic role of motor imagery on the functional rehabilitation of a stage II shoulder impingement syndrome. Disabil Rehabil. 2014;36(13):1113-9. doi: 10.3109/09638288.2013.833309. Epub 2014 Feb 28.
- The therapeutic role of motor imagery on the functional rehabilitation of a stage II shoulder impingement syndromeLink provided by the sponsor.
- Effectiveness of motor imagery and action observation training on musculoskeletal pain intensity: A systematic review and meta-analysisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cansu Ercan principal investigator
Unaffiliated"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional therapy, Graded motor imagery and Nintendo Wİİ in people with Rotator Cuff Injuries and Rotator Cuff Injury, run by Istanbul University - Cerrahpasa 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 4 inclusion and 4 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 30 Jul 2025. 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?
quickDASH short form (time frame: From enrollment to the end of treatment at 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06599567, which also lists 2 linked publications.
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 30 Jul 2025.