Rotator Cuff TearsNCT05670080
Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair?
A study testing Motor Imagery and Physical Therapy in people with Rotator Cuff Tears and Motor Imagery, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial summary
Objective: The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair. Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears, Motor Imagery, Muscle Activity
- What is being tested?
- Motor Imagery and Physical Therapy
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2027to 15 Dec 2029
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to speak and understand Turkish - Previous arthroscopic rotator cuff repair
- Achieving a minimum of 40 points on the Kinesthetic and Visual Imagery Questionnaire -20 (KGIA-20)
- Access to adequate technological devices for communication and follow-up
Who cannot join
- Who with neurological diseases that may cause functional impairment.
- Patients who have another shoulder problem and/or have had previous shoulder surgery on the same upper extremity.
- Who wanted to leave the study at their own request
- Who could not continue to work due to any additional discomfort developed
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Alanya Alaaddin Keykubat University
Alanya, Antalya
About this study
Official title: Does Motor Imagination Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? Randomized Controlled, Single-Blind Trial
Objective: The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair.
Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (MI group) and Group 2 (Control group) (Randomizer.org). Both groups will receive a 4-week physical therapy program. MI (Motor Imagination) group will receive a motor imagination program in addition to the physical therapy program. Data will collect using the visual analog scale (VAS), goniometric measurement, circumference measurement, Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Kinesthetic and Visual Imagery Questionnaire- KVIQ-20, Tampa Kinesiophobia Scale, 3-question satisfaction questionnaire, superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).
Practice Implications: The current study will contribute to understanding how motor imagination affects muscle activity and muscle atrophy.
Read the detailed description
After shoulder trauma, the rotator cuff may sustain tears of varying degrees. Degenerative rotator cuff tears are an important cause of shoulder pain and dysfunction. Rotator cuff injuries can be treated conservatively, medically, and surgically. Surgical treatment can be performed as arthroscopic-assisted mini-open or full arthroscopic techniques. After rotator cuff repair, long-term immobilization can lead to complications of scar formation and related shoulder stiffness, pain, muscle/tendon atrophy, and delayed return to functional and occupational activities. Motor imagery (MI) can be used in cases that cause immobilization such as pain, fatigue, and loss of strength during and after injury, or in cases of limited access to healthcare facilities.
Motor imagery is the imagining of action without its physical execution and motor imagery elicits activity in brain regions that are normally activated during actual task performance. The brain perceives real experiences and the visualization process as similar. For this reason, imagery is considered a mental exercise. The functional equivalence hypothesis shows that there is a great deal of overlap between the neural substrates of physical and imagined movement execution.
In a study examining brain signals during magnetoencephalographic (MEG) evaluation and motor movements, it was stated that the primary motor (less than motor activity) and posterior parietal cortex were activated during MI.
Today, the majority of mental exercise studies are carried out in the field of neurological rehabilitation. There are many studies on stroke, multiple sclerosis, Parkinson's, spinal cord injury, and phantom pain. MI is an effective method for motor learning that is also used in orthopedics and sports. The MI application may be an appropriate tool for professional athletes to maintain and improve their physical performance capacity. In a systematic review of the effect of MI on pain and motor function after spinal cord injury, the majority of the findings confirmed the benefits of MI interventions on the motor function when used concurrently with physical exercises. According to the findings of the systematic review published by Colmenero et al., MI has positive effects on phantom pain. Studies in patients with chronic shoulder pain syndrome and subacromial impingement syndrome have reported positive effects of MI on pain and shoulder function and active range of motion. Significantly positive results were observed in pain and disability scores after the 4th week with MI application in rotator cuff patients. Significantly positive results were observed in pain and disability scores after the 4th week of MI application in rotator cuff patients. In conclusion, extensive experimental research indicates that MI is a valuable and cost-effective technique for improving engine performance and recovery. There has been no research into the effectiveness of MI after rotator cuff repair.
The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair.
Methods:
Participants:
Volunteer participants who applied to the Orthopedics and Traumatology unit at Alanya Alaaddin Keykubat University Hospital, underwent arthroscopic rotator cuff repair by the same surgeon, and met the inclusion and exclusion criteria will take part in the study. Each participant enrolled in the study will be given detailed information about the study, and their written and verbal consent will be obtained.
According to the power analysis made with the G-power program, it was found that 80% power can be obtained with 95% confidence when at least 30 people are included in the study. While calculating the sample size, the results of the superficial EMG (-superior trapezius muscle peak dynamic value [experimental group: 35.99 (standard deviation: 14.39), control group 19.57 (standard deviation: 15.97)] were taken as a basis, and the effect size was calculated as = 1.08. The risk of case loss was taken into account by taking a reserve rate of 20%, and it was planned to include 36 participants. The cases will be divided into 2 groups by block randomization using the internet program, consisting of at least 18 individuals: Group 1 [MI group] and Group 2 [Control group] (Randomizer.org).
Study Protocol:
The study will be divided into two parallel groups: the MI group and the Control group. Both groups will participate in a routine physical therapy program after 4 weeks of immobilization, with the MI group receiving additional motor imagery training during the preoperative period.
A physiotherapist with a master's degree who will apply for the treatment program and is unaware of the study's content will administer the assessments in the pre-operative period and post-operative 8th week. Data will collect using the descriptive Information form (prepared by the principal investigator), visual analog scale (VAS), goniometric measurement, circumference measurement, Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Kinesthetic and Visual Imagery Questionnaire- KVIQ-20, Tampa Kinesiophobia Scale, 3-question satisfaction questionnaire, superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).
Training and Exercise Applications:
MI training will be provided to Group 1 participants who are planning for rotator cuff repair in the pre-surgical period. The training will be prepared using the Microsoft PowerPoint program which includes written, visual and audio materials, as well as features that can be sent to participants ' phones/tablets/computers.
MI training will allow the participant to perform visual and kinesthetic imagery with visual and audible notifications and will include 6 exercises for the muscles around the shoulder, 3 exercises for strengthening, and dynamic stabilization for the muscles around the scapula. In each presentation, verbal cues will be given to explain how to imagine the movement while a visual of the motor movement is displayed on the screen. Participants will be given 10 seconds of time, beginning and ending with an audible beep, and each exercise will be repeated 10 times before transitioning to the next exercise. Participants will be told in detail that they should begin MI exercises on the third day after surgery and continue them for four weeks. During MI exercises, participants will be called once a week and their MI practices will be followed up, as well as support for the questions and problems they experience. Group 1 will then participate in a 4-week physical therapy program, which will include electrotherapy, cold application, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder.
Following the preoperative evaluations, both groups will be shown remedial exercises (pumping exercises that activate the circulation), flexion, and extension wrist exercises, which they should do for four weeks. After a 4-week immobilization period, participants in Group 2 will begin a physical therapy program that includes routine electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder. The MI training will be applied by the principal investigator. The physical therapy program will be applied by a physiotherapist with a master's degree and 8 years of professional experience in the field of orthopedic rehabilitation, who is different from the principal investigator of the study.
Statistical Analysis:
In the statistical analysis of data will obtain in this study, a Windows-based SPSS (IBM SPSS Statistics, Version 24.0, Armonk, NY, USA) package program will use. Continuous variables will express as a mean ± standard deviation or as a median (minimum-maximum values), and categorical variables as a number and percent. Analytical (Kolmogorov-Smirnov/Shapiro-Wilks test) and visual (Histogram and probability graphs) methods will use to test the conformity of data for normal distribution. When the parametric test assumptions were provided, Independent Sample T-Test will use to compare independent group differences; when the parametric test assumptions were not provided, the Mann Whitney-U test will use to compare independent group differences. In the dependent group analyses; when the parametric test assumptions were provided, Paired Sample T-Test will use; when the parametric test assumptions were not provided, Wilcoxon Test will use. Chi-Square Analysis and Fisher Exact Test will use compare differences between categorical variables.
- Conditions
- Rotator Cuff Tears, Motor Imagery, Muscle Activity, Atrophy, Muscular, Patient Satisfaction, Kinesiophobia
- Being tested
- Motor Imagery, Physical Therapy
- Keywords
- Motor Imagery, Muscle Activity, Muscular Atrophy, Rotator Cuff Tears
- Medical subject headings
- Rotator Cuff Injuries, Muscular Atrophy, Patient Satisfaction, Kinesiophobia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor ImageryBehavioural
Motor imagery is the imagining of action without its physical execution and motor imagery elicits activity in brain regions that are normally activated during actual task performance. The brain perceives real experiences and the visualization process as similar. For this reason, imagery is considered a mental exercise
Physical TherapyBehavioural
Electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder.
| Study group | Role | What they receive |
|---|---|---|
| The Motor Imagery (MI) Group | Experimental | MI training will be prepared using the Microsoft PowerPoint program which includes written, visual and audio materials, as well as features that can be sent to participants ' phones/tablets/computers. The MI training will allow the participant to perform visual and kinesthetic imagery with visual and audible notifications and will include 6 exercises for the muscles around the shoulder, 3 exercises for strengthening, and dynamic stabilization for the muscles around the scapula. In each presentation, verbal cues will be given to explain how to imagine the movement while a visual of the motor movement is displayed on the screen. During MI exercises, participants will be called once a week and their MI practices will be followed up.
After the first four weeks of MI training, the MI group will also participate in a four-week physical therapy program. Receives: Behavioral: Motor Imagery; Behavioral: Physical Therapy |
| Physical Therapy (PT) Group | Experimental | Following the preoperative evaluations, both groups will be shown remedial exercises (pumping exercises that activate the circulation), flexion, and extension wrist exercises, which they should do for four weeks.
After a 4-week immobilization period, participants in the PT Group will begin a physical therapy program that includes routine electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder. Receives: Behavioral: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Muscle activity
Change of Muscle activity will be evaluated with superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).
Measured: 1 week before surgery and week 8 after surgery
Change of shoulder functional level
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) will be used to determine the upper extremity functional level.The total of all item scores was then used to calculate the interrogation score, which ranged from 0 (no disability) to 100. (most severe disability). The first 20 questions concern physical competence, while the last ten concern pain and functional and environmental limitations.
Measured: 1 week before surgery and week 8 after surgery
Change of Kinesthetic and visual imagery levels
The Kinesthetic and Visual Imagery Questionnaire- KVIQ-20 will be used to assess the kinesthetic and visual imagery levels of healthy and physically disabled individuals.The questionnaire contains a total of 20 titles, 10 of which are visual and 10 of which are kinesthetic. The intensity level of imagery is recorded on a 5-point Likert scale with the questionnaire (5 = appearance of a live image; 1 = no image or sensation).
Measured: 1 week before surgery and week 8 after surgery
Change of Kinesiophobia
Kinesiophobia was evaluated with Tampa Scale of Kinesiophobia (TSK).TSK is a 17-question checklist. The scale employs a 4-point Likert scoring system (1= strongly disagree, 4= completely agree).
Measured: 1 week before surgery and week 8 after surgery
Change of Patient Satisfaction
A Numerical Evaluation Scale will be used to evaluate a 2-question satisfaction questionnaire. This scale is made up of a horizontal straight line 10 cm long. The line has a value of 0 at the start and a value of 10 at the end, from left to right. On a scale of 0 to 10, patients will be asked to rate their level of satisfaction.
Measured: 1 week before surgery and week 8 after surgery
Secondary outcomes (4)
Descriptive Information
Age, gender, dominant hand, previous diseases, occupation and contact information of the patients were recorded in the descriptive information form.
Measured: 1 week before surgery
Change in Pain-Visual analog scale
Pain of patients during sleep, rest and activity will evaluate using a visual analog scale (VAS).This scale is made up of a 10 cm horizontal straight line. When viewed from left to right, a 0 at the start of the line indicates no pain, and a 10 at the end indicates severe pain.
Measured: 1 week before surgery, week 4 and week 8 after surgery
Change of Range of Motion
The limitation of shoulder joint flexion, extension, abduction, adduction, internal and external rotation movements will be measured using a universal goniometer and recorded in degrees(˚).
Measured: 1 week before surgery, week 4 and week 8 after surgery
Change in muscle atrophy
For changes in muscle atrophy, circumference measurements (one of Anthropometric measurements) will be used.
Measured: 1 week before surgery and week 8 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start15 Sep 2027 (estimated)
- Primary completion15 Jul 2028 (estimated)
- Study completion15 Dec 2029 (estimated)
Why it stopped: Due to the continuation of my PhD thesis process, patient admission will begin after the completion of my PhD graduation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be divided into two parallel groups: the MI group and the Control group. Both groups will participate in a routine physical therapy program after 4 weeks of immobilization, with the MI group receiving additional motor imagery training during the preoperative period. MI training will be provided to Group 1 participants who are planning for rotator cuff repair in the pre-surgical period by the corresponding researcher. The physical therapy program will be applied by a physiotherapist with a master's degree and 8 years of professional experience in the field of orthopedic rehabilitation, who is different from the corresponding researcher of the study.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University, Alanya Hamdullah Emin Pasha University
- Responsible party
- Principal investigator, Ozum Cetinkaya, Alanya Alaaddin Keykubat University
- Investigators
- Özüm ÇETİNKAYA EREN, PT, MSc, Principal investigator, Alanya Alaaddin Keykubat UniversityUmmuhan BAŞ ASLAN, Prof.Dr.PT., Study director, Pamukkale UniversityKazım Emre EREN, PT, MSc, Study chair, Alanya Alaaddin Keykubat University HospitalAnıl GÜLCÜ, Asst.Prof.Dr, Study chair, Alanya Alaaddin Keykubat UniversityErdem DEMİR, Asst.Prof.Dr, Study chair, Alanya Hamdullah Emin Paşa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670080
- Sponsor's protocol ID
- MIafterARCR
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2022
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Araya-Quintanilla F, Gutierrez-Espinoza H, Jesus Munoz-Yanez M, Rubio-Oyarzun D, Cavero-Redondo I, Martinez-Vizcaino V, Alvarez-Bueno C. The Short-term Effect of Graded Motor Imagery on the Affective Components of Pain in Subjects with Chronic Shoulder Pain Syndrome: Open-Label Single-Arm Prospective Study. Pain Med. 2020 Oct 1;21(10):2496-2501. doi: 10.1093/pm/pnz364.
PubMed 32003812Guillot A, Collet C, Nguyen VA, Malouin F, Richards C, Doyon J. Brain activity during visual versus kinesthetic imagery: an fMRI study. Hum Brain Mapp. 2009 Jul;30(7):2157-72. doi: 10.1002/hbm.20658.
PubMed 18819106Boden-Albala B, Roberts ET, Bazil C, Moon Y, Elkind MS, Rundek T, Paik MC, Sacco RL. Daytime sleepiness and risk of stroke and vascular disease: findings from the Northern Manhattan Study (NOMAS). Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):500-7. doi: 10.1161/CIRCOUTCOMES.111.963801. Epub 2012 Jul 10.
PubMed 22787063Chholak P, Niso G, Maksimenko VA, Kurkin SA, Frolov NS, Pitsik EN, Hramov AE, Pisarchik AN. Visual and kinesthetic modes affect motor imagery classification in untrained subjects. Sci Rep. 2019 Jul 8;9(1):9838. doi: 10.1038/s41598-019-46310-9.
PubMed 31285468Hayes K, Walton JR, Szomor ZR, Murrell GA. Reliability of five methods for assessing shoulder range of motion. Aust J Physiother. 2001;47(4):289-94. doi: 10.1016/s0004-9514(14)60274-9.
PubMed 11722295Matlak S, Andrews A, Looney A, Tepper KB. Postoperative Rehabilitation of Rotator Cuff Repair: A Systematic Review. Sports Med Arthrosc Rev. 2021 Jun 1;29(2):119-129. doi: 10.1097/JSA.0000000000000310.
PubMed 33972488Opsommer E, Chevalley O, Korogod N. Motor imagery for pain and motor function after spinal cord injury: a systematic review. Spinal Cord. 2020 Mar;58(3):262-274. doi: 10.1038/s41393-019-0390-1. Epub 2019 Dec 13.
PubMed 31836873Herrador Colmenero L, Perez Marmol JM, Marti-Garcia C, Querol Zaldivar MLA, Tapia Haro RM, Castro Sanchez AM, Aguilar-Ferrandiz ME. Effectiveness of mirror therapy, motor imagery, and virtual feedback on phantom limb pain following amputation: A systematic review. Prosthet Orthot Int. 2018 Jun;42(3):288-298. doi: 10.1177/0309364617740230. Epub 2017 Nov 20.
PubMed 29153043
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Motor Imagination Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? Randomized Controlled, Single-Blind Trial
- ClinicalTrials.gov ID
- NCT05670080
- Acronym / sponsor ID
- MIafterARCR
- Conditions
- Rotator Cuff Tears, Motor Imagery, Muscle Activity, Atrophy, Muscular, Patient Satisfaction, Kinesiophobia
- Keywords
- Motor Imagery, Muscle Activity, Muscular Atrophy, Rotator Cuff Tears
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Due to the continuation of my PhD thesis process, patient admission will begin after the completion of my PhD graduation.
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Collaborators
- Pamukkale University, Alanya Hamdullah Emin Pasha University
- Study start
- 15 Sep 2027 (estimated)
- Primary completion
- 15 Jul 2028 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 4 Jan 2023 (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.
Objective: The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair.
Methods: As a result of the power analysis (G-Power), 36 participants are planned to be included in this study Block randomization will be used to divide participants into 2 groups, each with at least 18 participants: Group 1 (MI group) and Group 2 (Control group) (Randomizer.org). Both groups will receive a 4-week physical therapy program. MI (Motor Imagination) group will receive a motor imagination program in addition to the physical therapy program. Data will collect using the visual analog scale (VAS), goniometric measurement, circumference measurement, Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Kinesthetic and Visual Imagery Questionnaire- KVIQ-20, Tampa Kinesiophobia Scale, 3-question satisfaction questionnaire, superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).
Practice Implications: The current study will contribute to understanding how motor imagination affects muscle activity and muscle atrophy.
Detailed description
After shoulder trauma, the rotator cuff may sustain tears of varying degrees. Degenerative rotator cuff tears are an important cause of shoulder pain and dysfunction. Rotator cuff injuries can be treated conservatively, medically, and surgically. Surgical treatment can be performed as arthroscopic-assisted mini-open or full arthroscopic techniques. After rotator cuff repair, long-term immobilization can lead to complications of scar formation and related shoulder stiffness, pain, muscle/tendon atrophy, and delayed return to functional and occupational activities. Motor imagery (MI) can be used in cases that cause immobilization such as pain, fatigue, and loss of strength during and after injury, or in cases of limited access to healthcare facilities.
Motor imagery is the imagining of action without its physical execution and motor imagery elicits activity in brain regions that are normally activated during actual task performance. The brain perceives real experiences and the visualization process as similar. For this reason, imagery is considered a mental exercise. The functional equivalence hypothesis shows that there is a great deal of overlap between the neural substrates of physical and imagined movement execution.
In a study examining brain signals during magnetoencephalographic (MEG) evaluation and motor movements, it was stated that the primary motor (less than motor activity) and posterior parietal cortex were activated during MI.
Today, the majority of mental exercise studies are carried out in the field of neurological rehabilitation. There are many studies on stroke, multiple sclerosis, Parkinson's, spinal cord injury, and phantom pain. MI is an effective method for motor learning that is also used in orthopedics and sports. The MI application may be an appropriate tool for professional athletes to maintain and improve their physical performance capacity. In a systematic review of the effect of MI on pain and motor function after spinal cord injury, the majority of the findings confirmed the benefits of MI interventions on the motor function when used concurrently with physical exercises. According to the findings of the systematic review published by Colmenero et al., MI has positive effects on phantom pain. Studies in patients with chronic shoulder pain syndrome and subacromial impingement syndrome have reported positive effects of MI on pain and shoulder function and active range of motion. Significantly positive results were observed in pain and disability scores after the 4th week with MI application in rotator cuff patients. Significantly positive results were observed in pain and disability scores after the 4th week of MI application in rotator cuff patients. In conclusion, extensive experimental research indicates that MI is a valuable and cost-effective technique for improving engine performance and recovery. There has been no research into the effectiveness of MI after rotator cuff repair.
The aim of this study is to investigate the effect of motor imagery on muscle activity, pain, and function in arthroscopic rotator cuff repair.
Methods:
Participants:
Volunteer participants who applied to the Orthopedics and Traumatology unit at Alanya Alaaddin Keykubat University Hospital, underwent arthroscopic rotator cuff repair by the same surgeon, and met the inclusion and exclusion criteria will take part in the study. Each participant enrolled in the study will be given detailed information about the study, and their written and verbal consent will be obtained.
According to the power analysis made with the G-power program, it was found that 80% power can be obtained with 95% confidence when at least 30 people are included in the study. While calculating the sample size, the results of the superficial EMG (-superior trapezius muscle peak dynamic value [experimental group: 35.99 (standard deviation: 14.39), control group 19.57 (standard deviation: 15.97)] were taken as a basis, and the effect size was calculated as = 1.08. The risk of case loss was taken into account by taking a reserve rate of 20%, and it was planned to include 36 participants. The cases will be divided into 2 groups by block randomization using the internet program, consisting of at least 18 individuals: Group 1 [MI group] and Group 2 [Control group] (Randomizer.org).
Study Protocol:
The study will be divided into two parallel groups: the MI group and the Control group. Both groups will participate in a routine physical therapy program after 4 weeks of immobilization, with the MI group receiving additional motor imagery training during the preoperative period.
A physiotherapist with a master's degree who will apply for the treatment program and is unaware of the study's content will administer the assessments in the pre-operative period and post-operative 8th week. Data will collect using the descriptive Information form (prepared by the principal investigator), visual analog scale (VAS), goniometric measurement, circumference measurement, Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH), Kinesthetic and Visual Imagery Questionnaire- KVIQ-20, Tampa Kinesiophobia Scale, 3-question satisfaction questionnaire, superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).
Training and Exercise Applications:
MI training will be provided to Group 1 participants who are planning for rotator cuff repair in the pre-surgical period. The training will be prepared using the Microsoft PowerPoint program which includes written, visual and audio materials, as well as features that can be sent to participants ' phones/tablets/computers.
MI training will allow the participant to perform visual and kinesthetic imagery with visual and audible notifications and will include 6 exercises for the muscles around the shoulder, 3 exercises for strengthening, and dynamic stabilization for the muscles around the scapula. In each presentation, verbal cues will be given to explain how to imagine the movement while a visual of the motor movement is displayed on the screen. Participants will be given 10 seconds of time, beginning and ending with an audible beep, and each exercise will be repeated 10 times before transitioning to the next exercise. Participants will be told in detail that they should begin MI exercises on the third day after surgery and continue them for four weeks. During MI exercises, participants will be called once a week and their MI practices will be followed up, as well as support for the questions and problems they experience. Group 1 will then participate in a 4-week physical therapy program, which will include electrotherapy, cold application, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder.
Following the preoperative evaluations, both groups will be shown remedial exercises (pumping exercises that activate the circulation), flexion, and extension wrist exercises, which they should do for four weeks. After a 4-week immobilization period, participants in Group 2 will begin a physical therapy program that includes routine electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder. The MI training will be applied by the principal investigator. The physical therapy program will be applied by a physiotherapist with a master's degree and 8 years of professional experience in the field of orthopedic rehabilitation, who is different from the principal investigator of the study.
Statistical Analysis:
In the statistical analysis of data will obtain in this study, a Windows-based SPSS (IBM SPSS Statistics, Version 24.0, Armonk, NY, USA) package program will use. Continuous variables will express as a mean ± standard deviation or as a median (minimum-maximum values), and categorical variables as a number and percent. Analytical (Kolmogorov-Smirnov/Shapiro-Wilks test) and visual (Histogram and probability graphs) methods will use to test the conformity of data for normal distribution. When the parametric test assumptions were provided, Independent Sample T-Test will use to compare independent group differences; when the parametric test assumptions were not provided, the Mann Whitney-U test will use to compare independent group differences. In the dependent group analyses; when the parametric test assumptions were provided, Paired Sample T-Test will use; when the parametric test assumptions were not provided, Wilcoxon Test will use. Chi-Square Analysis and Fisher Exact Test will use compare differences between categorical variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The study will be divided into two parallel groups: the MI group and the Control group. Both groups will participate in a routine physical therapy program after 4 weeks of immobilization, with the MI group receiving additional motor imagery training during the preoperative period. MI training will be provided to Group 1 participants who are planning for rotator cuff repair in the pre-surgical period by the corresponding researcher. The physical therapy program will be applied by a physiotherapist with a master's degree and 8 years of professional experience in the field of orthopedic rehabilitation, who is different from the corresponding researcher of the study.
| Arm | Type | Receives |
|---|---|---|
| The Motor Imagery (MI) Group | Experimental | Behavioral: Motor Imagery, Behavioral: Physical TherapyMI training will be prepared using the Microsoft PowerPoint program which includes written, visual and audio materials, as well as features that can be sent to participants ' phones/tablets/computers. The MI training will allow the participant to perform visual and kinesthetic imagery with visual and audible notifications and will include 6 exercises for the muscles around the shoulder, 3 exercises for strengthening, and dynamic stabilization for the muscles around the scapula. In each presentation, verbal cues will be given to explain how to imagine the movement while a visual of the motor movement is displayed on the screen. During MI exercises, participants will be called once a week and their MI practices will be followed up. After the first four weeks of MI training, the MI group will also participate in a four-week physical therapy program. |
| Physical Therapy (PT) Group | Experimental | Behavioral: Physical TherapyFollowing the preoperative evaluations, both groups will be shown remedial exercises (pumping exercises that activate the circulation), flexion, and extension wrist exercises, which they should do for four weeks. After a 4-week immobilization period, participants in the PT Group will begin a physical therapy program that includes routine electrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to speak and understand Turkish - Previous arthroscopic rotator cuff repair
- Achieving a minimum of 40 points on the Kinesthetic and Visual Imagery Questionnaire -20 (KGIA-20)
- Access to adequate technological devices for communication and follow-up
Key exclusion criteria (4 listed)
- Who with neurological diseases that may cause functional impairment.
- Patients who have another shoulder problem and/or have had previous shoulder surgery on the same upper extremity.
- Who wanted to leave the study at their own request
- Who could not continue to work due to any additional discomfort developed
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 |
|---|---|---|
| Motor ImageryMotor imagery is the imagining of action without its physical execution and motor imagery elicits activity in brain regions that are normally activated during actual task performance. The brain perceives real experiences and the visualization process as similar. For this reason, imagery is considered a mental exercise | Behavioural | The Motor Imagery (MI) Group |
| Physical TherapyElectrotherapy (TENS), cold pack therapy, joint range of motion exercises, and strengthening exercises for the muscles around the shoulder. | Behavioural | Physical Therapy (PT) Group, The Motor Imagery (MI) Group |
Primary outcome
Change of Muscle activity
Time frame: 1 week before surgery and week 8 after surgery
Change of Muscle activity will be evaluated with superficial Electromyography (EMG) (BTS Bioengineering Free EMG 100 RT).
Change of shoulder functional level
Time frame: 1 week before surgery and week 8 after surgery
Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH) will be used to determine the upper extremity functional level.The total of all item scores was then used to calculate the interrogation score, which ranged from 0 (no disability) to 100. (most severe disability). The first 20 questions concern physical competence, while the last ten concern pain and functional and environmental limitations.
Change of Kinesthetic and visual imagery levels
Time frame: 1 week before surgery and week 8 after surgery
The Kinesthetic and Visual Imagery Questionnaire- KVIQ-20 will be used to assess the kinesthetic and visual imagery levels of healthy and physically disabled individuals.The questionnaire contains a total of 20 titles, 10 of which are visual and 10 of which are kinesthetic. The intensity level of imagery is recorded on a 5-point Likert scale with the questionnaire (5 = appearance of a live image; 1 = no image or sensation).
Change of Kinesiophobia
Time frame: 1 week before surgery and week 8 after surgery
Kinesiophobia was evaluated with Tampa Scale of Kinesiophobia (TSK).TSK is a 17-question checklist. The scale employs a 4-point Likert scoring system (1= strongly disagree, 4= completely agree).
Change of Patient Satisfaction
Time frame: 1 week before surgery and week 8 after surgery
A Numerical Evaluation Scale will be used to evaluate a 2-question satisfaction questionnaire. This scale is made up of a horizontal straight line 10 cm long. The line has a value of 0 at the start and a value of 10 at the end, from left to right. On a scale of 0 to 10, patients will be asked to rate their level of satisfaction.
4 secondary outcomes
Descriptive Information
Time frame: 1 week before surgery
Change in Pain-Visual analog scale
Time frame: 1 week before surgery, week 4 and week 8 after surgery
Change of Range of Motion
Time frame: 1 week before surgery, week 4 and week 8 after surgery
Change in muscle atrophy
Time frame: 1 week before surgery and week 8 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 32003812Araya-Quintanilla F, Gutierrez-Espinoza H, Jesus Munoz-Yanez M, Rubio-Oyarzun D, Cavero-Redondo I, Martinez-Vizcaino V, Alvarez-Bueno C. The Short-term Effect of Graded Motor Imagery on the Affective Components of Pain in Subjects with Chronic Shoulder Pain Syndrome: Open-Label Single-Arm Prospective Study. Pain Med. 2020 Oct 1;21(10):2496-2501. doi: 10.1093/pm/pnz364.
- Background: PubMed 18819106Guillot A, Collet C, Nguyen VA, Malouin F, Richards C, Doyon J. Brain activity during visual versus kinesthetic imagery: an fMRI study. Hum Brain Mapp. 2009 Jul;30(7):2157-72. doi: 10.1002/hbm.20658.
- Background: PubMed 22787063Boden-Albala B, Roberts ET, Bazil C, Moon Y, Elkind MS, Rundek T, Paik MC, Sacco RL. Daytime sleepiness and risk of stroke and vascular disease: findings from the Northern Manhattan Study (NOMAS). Circ Cardiovasc Qual Outcomes. 2012 Jul 1;5(4):500-7. doi: 10.1161/CIRCOUTCOMES.111.963801. Epub 2012 Jul 10.
- Background: PubMed 31285468Chholak P, Niso G, Maksimenko VA, Kurkin SA, Frolov NS, Pitsik EN, Hramov AE, Pisarchik AN. Visual and kinesthetic modes affect motor imagery classification in untrained subjects. Sci Rep. 2019 Jul 8;9(1):9838. doi: 10.1038/s41598-019-46310-9.
- Background: PubMed 11722295Hayes K, Walton JR, Szomor ZR, Murrell GA. Reliability of five methods for assessing shoulder range of motion. Aust J Physiother. 2001;47(4):289-94. doi: 10.1016/s0004-9514(14)60274-9.
- Background: PubMed 33972488Matlak S, Andrews A, Looney A, Tepper KB. Postoperative Rehabilitation of Rotator Cuff Repair: A Systematic Review. Sports Med Arthrosc Rev. 2021 Jun 1;29(2):119-129. doi: 10.1097/JSA.0000000000000310.
- Background: PubMed 31836873Opsommer E, Chevalley O, Korogod N. Motor imagery for pain and motor function after spinal cord injury: a systematic review. Spinal Cord. 2020 Mar;58(3):262-274. doi: 10.1038/s41393-019-0390-1. Epub 2019 Dec 13.
- Background: PubMed 29153043Herrador Colmenero L, Perez Marmol JM, Marti-Garcia C, Querol Zaldivar MLA, Tapia Haro RM, Castro Sanchez AM, Aguilar-Ferrandiz ME. Effectiveness of mirror therapy, motor imagery, and virtual feedback on phantom limb pain following amputation: A systematic review. Prosthet Orthot Int. 2018 Jun;42(3):288-298. doi: 10.1177/0309364617740230. Epub 2017 Nov 20.
- Individual participant dataSharing planned: No
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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.
Özüm ÇETİNKAYA EREN, PT, MSc principal investigator
Alanya Alaaddin Keykubat University
Ummuhan BAŞ ASLAN, Prof.Dr.PT. study director
Pamukkale University
Kazım Emre EREN, PT, MSc study chair
Alanya Alaaddin Keykubat University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor Imagery and Physical Therapy in people with Rotator Cuff Tears and Motor Imagery, run by Alanya Alaaddin Keykubat 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 3 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: paused, as of the sponsor's last update on 28 Oct 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?
Results are not available in the source record.
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?
Change of Muscle activity (time frame: 1 week before surgery and week 8 after surgery). The study lists 5 primary outcomes in all. 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 NCT05670080, which also lists 8 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 28 Oct 2026.