- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290660
Graded Motor Imagery and Task-Oriented Exercise in Shoulder Impingement
Effectiveness of Graded Motor Imagery and Task-Oriented Exercise Training in Shoulder Impingement Syndrome
This study aims to compare the effects of graded motor imagery and task-oriented exercise training in individuals with shoulder impingement syndrome. A total of 66 participants aged 25-65 years will be randomly assigned to one of three groups: conventional physiotherapy, graded motor imagery, or task-oriented exercise training. All groups will receive standardized electrotherapy, while the intervention groups will additionally complete 6-week graded motor imagery or task-oriented exercise programs.
Primary outcomes include pain intensity, shoulder range of motion, muscle strength, proprioception, functional status, kinesiophobia, laterality recognition, movement imagery ability, and patient satisfaction. Assessments will be conducted before and after the intervention by the same physiotherapist. The study aims to determine whether motor imagery-based or task-oriented rehabilitation provides additional benefits compared with conventional physiotherapy in individuals with shoulder impingement syndrome.
Study Overview
Status
Detailed Description
This study investigates the effects of graded motor imagery (GMI) and task-oriented exercise training on individuals diagnosed with shoulder impingement syndrome. Shoulder impingement is a common musculoskeletal problem that leads to pain, restricted mobility, reduced muscle strength, proprioceptive deficits, and functional limitations. Conventional physiotherapy approaches may not always be sufficient to address the complex sensorimotor deficits associated with this condition. Therefore, this study aims to evaluate whether GMI or task-oriented exercise programs can provide additional therapeutic benefits beyond standard physiotherapy.
A total of 66 participants, aged 25 to 65 years, who meet the diagnostic criteria for shoulder impingement syndrome, will be included. Participants will be randomly assigned to one of three groups:
Conventional physiotherapy (control group)
Graded motor imagery training
Task-oriented exercise training
All groups will receive standardized electrotherapy interventions as part of routine physiotherapy. In addition to this standard treatment, the two intervention groups will engage in a 6-week structured program based on either GMI or task-oriented exercises, depending on group allocation.
Outcome measures will include pain intensity, shoulder range of motion, muscle strength, proprioception, functional level, kinesiophobia, laterality recognition, movement imagery ability, and patient satisfaction. All assessments will be conducted before and after the 6-week intervention by the same physiotherapist to ensure consistency.
The purpose of this study is to determine whether GMI or task-oriented exercise training offers superior improvements in pain, motor performance, proprioceptive control, and functional outcomes when compared with conventional physiotherapy alone. The findings are expected to contribute to evidence-based rehabilitation practices and provide clinicians with additional strategies for managing shoulder impingement syndrome.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yeliz Çırak, PT, MSc
- Phone Number: 05373298320
- Email: yeliz.cirak@fbu.edu.tr
Study Contact Backup
- Name: Gülay Aras Bayram, Assoc. Prof.
- Phone Number: 05054966284
- Email: garas@medipol.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- Istanbul Medipol University, Institute of Health Sciences
-
Contact:
- Yeliz Çırak, PT, MSc
- Phone Number: 05373298320
- Email: yeliz.cirak@fbu.edu.tr
-
Contact:
- Gülay Aras Bayram, Assoc. Prof.
- Phone Number: 05054966284
- Email: garas@medipol.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:Adults aged 25-65 years
Diagnosed with Stage I or Stage II shoulder impingement syndrome by an Orthopedics or Physical Medicine and Rehabilitation physician
Positive Neer and Hawkins tests
Unilateral shoulder pain for at least 3 months
No participation in any physiotherapy program for shoulder problems within the last year
Ability to cooperate and follow instructions
A score of 24 or above on the Standardized Mini-Mental Test -
Exclusion Criteria:
History of previous shoulder surgery
Local corticosteroid injection within the last three months
Presence of uncontrolled neurological, cardiac, or systemic diseases that may interfere with function
Cognitive impairments that may affect proper understanding or execution of the motor imagery program
A score below 24 on the Standardized Mini-Mental Test
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional Physiotherapy
Participants in this group will receive conventional physiotherapy, including standardized electrotherapy and routine therapeutic exercises for shoulder impingement syndrome, for 6 weeks
|
All participants will receive an electrotherapy program consisting of TENS (100 Hz, 20 minutes), ultrasound (1.5 W/cm², 6 minutes), and cold pack application (15 minutes), delivered 5 days per week for 6 weeks.
The conventional exercise program includes wand exercises (flexion, abduction, extension, external/internal rotation), Codman exercises in multiple directions, and finger ladder exercises with a 5-second hold at end range.
Strengthening exercises will be performed without resistance during the first week, followed by progressive TheraBand® resistance from week two.
Posterior, anterior, and inferior capsule stretching, pectoral stretching, and shoulder-scapular mobilization will be performed under physiotherapist supervision.
Exercises will be applied twice weekly for 6 weeks, with 3 sets of 10 repetitions.
|
|
Active Comparator: Graded Motor Imagery
Participants in this group will receive a 6-week graded motor imagery program in addition to standardized electrotherapy
|
All participants will receive an electrotherapy program consisting of TENS (100 Hz, 20 minutes), ultrasound (1.5 W/cm², 6 minutes), and cold pack application (15 minutes), delivered 5 days per week for 6 weeks.
The conventional exercise program includes wand exercises (flexion, abduction, extension, external/internal rotation), Codman exercises in multiple directions, and finger ladder exercises with a 5-second hold at end range.
Strengthening exercises will be performed without resistance during the first week, followed by progressive TheraBand® resistance from week two.
Posterior, anterior, and inferior capsule stretching, pectoral stretching, and shoulder-scapular mobilization will be performed under physiotherapist supervision.
Exercises will be applied twice weekly for 6 weeks, with 3 sets of 10 repetitions.
The graded motor imagery program consists of 2 weeks of laterality training, 2 weeks of motor imagery, and 2 weeks of mirror therapy.
Laterality training will be performed using the Recognise™ Shoulder app (NOI), where participants identify whether presented images show a right or left shoulder.
Training will be conducted twice weekly for 2 weeks.
Motor imagery includes viewing shoulder movement images (flexion 180°, abduction 180°, external rotation 90°, internal rotation 90°, extension 45°) and mentally rehearsing the movements for 3 sets of 10 repetitions.
Mirror therapy requires participants to view the reflection of their unaffected shoulder and perform the imagined movements.
Mirror therapy will also be applied twice weekly for 2 weeks, with 3 sets of 10 repetitions
|
|
Active Comparator: Task-Oriented Exercise Training
Participants in this group will receive a 6-week task-oriented exercise training program in addition to standardized electrotherapy.
|
All participants will receive an electrotherapy program consisting of TENS (100 Hz, 20 minutes), ultrasound (1.5 W/cm², 6 minutes), and cold pack application (15 minutes), delivered 5 days per week for 6 weeks.
The conventional exercise program includes wand exercises (flexion, abduction, extension, external/internal rotation), Codman exercises in multiple directions, and finger ladder exercises with a 5-second hold at end range.
Strengthening exercises will be performed without resistance during the first week, followed by progressive TheraBand® resistance from week two.
Posterior, anterior, and inferior capsule stretching, pectoral stretching, and shoulder-scapular mobilization will be performed under physiotherapist supervision.
Exercises will be applied twice weekly for 6 weeks, with 3 sets of 10 repetitions.
The task-oriented exercise program is based on daily activities related to DASH and SPADI items, focusing on functional shoulder movements including flexion, abduction, extension, and rotation.
Exercises will be performed twice weekly for 6 weeks, 3 sets of 10 repetitions.
Weeks 0-2 include placing an object on a front shelf, placing an object on a side shelf, placing the hand on the back, touching the neck, washing a plate, and wiping a wall within pain limits.
Weeks 2-4 include changing an overhead light bulb, washing hair, combing hair, putting on and taking off a pullover shirt, and donning a jacket or cardigan.
Weeks 4-6 include placing a 0.5-kg weight on an overhead shelf (front and side), washing or scratching the upper and lower back, and placing a wallet in the back pocket.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Muscle Strength
Time Frame: At baseline and at the end of the 6-week intervention period
|
Muscle strength will be assessed using the Lafayette Manual Muscle Tester (MMT).
Shoulder flexion, extension, abduction, internal rotation, and external rotation muscle strengths will be evaluated.
Three consecutive measurements will be taken for each movement, and the mean value will be recorded.
|
At baseline and at the end of the 6-week intervention period
|
|
Assessment of Pain Intensity
Time Frame: At baseline and at the end of the 6-week intervention period
|
Pain intensity will be assessed using a 10 cm Visual Analog Scale (VAS), ranging from '0' (no pain) to '10' (unbearable pain).
Participants will rate their pain levels before and after the intervention in three conditions: at rest, during activity, and at night
|
At baseline and at the end of the 6-week intervention period
|
|
Assessment of Pain Threshold
Time Frame: At baseline and at the end of the 6-week intervention period
|
The pain threshold will be assessed using an algometer, a device that measures the pressure at which pain is first perceived.
During the measurement, the participant must remain in a relaxed position, and the tip of the algometer must be applied at a 90-degree angle to the tissue.
As pressure gradually increases, the participant will be instructed to indicate the moment when pain or discomfort is first felt.
This point will be recorded as the pain threshold .
In this study, the Commander Echo Algometer will be used to assess pain thresholds.
Measurements will be taken from the deltoid muscle, supraspinatus muscle, infraspinatus muscle, and the participant's self-reported most painful area.
Each measurement will be repeated three times, and the mean value will be recorded.
|
At baseline and at the end of the 6-week intervention period
|
|
Assessment of Shoulder Range of Motion
Time Frame: At baseline and at the end of the 6-week intervention period
|
Shoulder range of motion will be assessed using a Baseline goniometer (RMS UK Ltd., Nailsea).
The joint movements to be evaluated include flexion, extension, abduction, internal rotation, and external rotation, and the results will be recorded in degrees.
For each movement, three consecutive measurements will be taken, and the mean value will be used for analysis
|
At baseline and at the end of the 6-week intervention period
|
|
Assessment of Active Joint Position Sense
Time Frame: At baseline and at the end of the 6-week intervention period
|
Active shoulder joint position sense will be assessed using a smartphone goniometer application with proven validity and reliability.
Elevation angles of 40° and 100° in the scapular plane will be tested.
A smartphone will be placed in an armband positioned over the biceps brachii on the tested side.
With eyes open, participants will first learn the target angle through passive movement.
Then, with eyes closed, the shoulder will be passively positioned at the target angle three times for familiarization.
Participants will then actively reproduce the angle.
The test will be repeated six times with 5 seconds of rest between trials.
The same procedure will be performed for both 40° and 100° elevations on both shoulders.
|
At baseline and at the end of the 6-week intervention period
|
|
Assessment of Upper Extremity Function
Time Frame: At baseline and at the end of the 6-week intervention period
|
Functional assessment of the shoulder will be performed using the Shoulder Pain and Disability Index (SPADI).
SPADI consists of 13 items divided into two subscales: pain and disability.
The pain subscale includes five questions related to shoulder pain during activities, while the disability subscale includes eight questions evaluating difficulty in performing daily activities.
Both subscale scores and the total score range from 0 to 100, with higher scores indicating greater pain and disability
|
At baseline and at the end of the 6-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of Laterality Recognition
Time Frame: At baseline and at the end of the 6-week intervention period
|
Shoulder laterality performance will be assessed using the 'Recognise™' application developed by the Neuro Orthopaedic Institute.
The 'Recognise™ Shoulder' section of the app, specifically the 'Vanilla' mode, will be used.
A total of 20 shoulder images will be presented for 5 seconds each.
Participants will be asked to identify as quickly and accurately as possible whether the displayed image represents a right or left shoulder by pressing the corresponding button on the screen.
The percentage of correct responses and reaction time will be recorded as outcome measures.
|
At baseline and at the end of the 6-week intervention period
|
|
Assessment of Movement Imagery Ability
Time Frame: At baseline and at the end of the 6-week intervention period
|
Movement imagery ability will be assessed using the Movement Imagery Questionnaire-3 (MIQ-3).
The questionnaire consists of 12 items.
Participants are asked to imagine four different movements using internal visual imagery, external visual imagery, and kinesthetic imagery.
They rate the clarity or ease of imagining each movement on a 7-point ordinal scale (1 = very hard to feel/see, 7 = very easy to feel/see)
|
At baseline and at the end of the 6-week intervention period
|
|
Assessment of Kinesiophobia
Time Frame: At baseline and at the end of the 6-week intervention period
|
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK), developed by Miller, Kori, and Todd.
The scale consists of 17 items evaluating fear of injury, reinjury, fear-avoidance beliefs, and activity-related concerns.
Each item is scored on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree).
Higher scores indicate a higher level of kinesiophobia.
|
At baseline and at the end of the 6-week intervention period
|
|
Assessment of Patient Satisfaction
Time Frame: It will be assessed at the end of the 6-week treatment period.
|
Patient satisfaction with treatment will be assessed using the Global Rating of Change (GRC) Scale.
This scale is widely used in clinical research, particularly in musculoskeletal conditions.
It is designed to measure a patient's perceived improvement or deterioration over time, either to determine the effectiveness of an intervention or to track clinical progress.
The version used in this study consists of 5 levels and is scored between -2 and +2.
|
It will be assessed at the end of the 6-week treatment period.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FBU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Boston Scientific CorporationRecruitingLow Back Pain | Chronic Pain | Chronic Low-back Pain | Leg Pain | Intractable Pain | Chronic Leg PainUnited States
-
Qi's ClinicNot yet recruitingNon-Cancer Pain,Musculoskeletal Pain,Chronic Pain,Acute Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on Electrotherapy + Conventional Exercise Group
-
Istanbul Medipol University HospitalBahçeşehir UniversityCompletedPain, Chronic | Walking, Difficulty | Osteoarthritis Knees BothTurkey
-
Brno University HospitalRecruiting
-
Gaziosmanpasa Research and Education HospitalRecruiting
-
Istanbul Medipol University HospitalRecruitingSubacromial Impingement Syndrome | Soft Tissue Injuries | Massage | Instrument-Assisted Soft Tissue MobilizationTurkey (Türkiye)
-
Medipol UniversityRecruitingRotator Cuff SyndromeTurkey (Türkiye)
-
Istanbul Medipol University HospitalCompleted
-
Bahçeşehir UniversityUnknown
-
Muğla Sıtkı Koçman UniversityRecruitingChronic Neck PainTurkey
-
Istanbul University - Cerrahpasa (IUC)CompletedRotator Cuff Tear or Rupture, Not Specified as Traumatic | Pain, ShoulderTurkey
-
Ankara Yildirim Beyazıt UniversityCompleted