- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03969277
Graded Motor Imagery in Elbow Limitation
June 30, 2021 updated by: Tansu Birinci, Istanbul University - Cerrahpasa (IUC)
The Effectiveness of Graded Motor Imagery Training in Elbow Limitation
This randomized-controlled trial aims to investigate the efficacy of Graded Motor Imagery (GMI) on function, pain, and range of motion (ROM) in patients with a posttraumatic stiff elbow.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
To investigate the efficacy of GMI on function, pain, and ROM in elbow limitation, voluntary patients with elbow limitation, aged between 20-55 years will be randomly divided into two groups: GMI group and standard rehabilitation (SR) group.
Interventions will be applied for 12 sessions.
The patients will be assessed before, after six-week treatment and six-week follow-up.
The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS).
Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry.
ROM will be assessed with a digital goniometer.
Isometric muscle strength will be measured with a handheld dynamometer of elbow flexors and extensors.
Grip strength will also be assessed.
Recognise™ will be used for assessing the right-left discrimination.
The functional status and kinesiophobia will be evaluated by Disabilities Arm, Shoulder and Hand (DASH) and Tampa Scale for Kinesiophobia, respectively.
The Global Rating of Change will be used to evaluate patient satisfaction.
The Vividness of Movement Imagery Questionnaire 2 (VMIQ-2) will be used for evaluating the individuals' ability to mental imaginary.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bakırkoy
-
Istanbul, Bakırkoy, Turkey, 34147
- Istanbul University-Cerrahpasa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Subjects will be included with
- Aged between 20 and 55 years
- Elbow fracture in the six months before the study
- Elbow limitation in flexion or extension
- Being a volunteer to participate
- Fractures should be managed with surgically
- The "Standardized Mini Mental Test" result must be at least 24 points
Exclusion Criteria:
- Malunion or Nonunion Fracture
- The occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
- Non-healing wound or infection
- Previously received physiotherapy for elbow limitation
- Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
- Could not adjust to the treatment
- Shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity
- Having severe visual loss
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Graded Motor Imagery
Each subject in the Graded Motor Imagery group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, and home exercises.
|
The first stage of GMI includes laterality reconstruction.
Patients will view and determine if the various images of body parts to image portrays the right or left side.
The second stage targets activation of the primary motor cortex by imagine moving the involved body part.
The final stage involves that the patient watches the unaffected body part moving in a mirror to "trick" the brain into thinking the affected body part is actually moving in a pain-free way.
This will be applied for 6 weeks.
Proprioception exercises for the elbow.
Scapulothoracic strengthening exercises.
This will be applied for 6 weeks.
Cold application around the elbow joint for 15 minutes in every session.
|
Active Comparator: Standard Rehabilitation
Each subject in the Standard Rehabilitation group will receive a treatment protocol consisting of stretching and strengthening exercises, cold therapy, and home exercises.
|
Proprioception exercises for the elbow.
Scapulothoracic strengthening exercises.
This will be applied for 6 weeks.
Cold application around the elbow joint for 15 minutes in every session.
Shoulder, elbow and wrist AROM exercises.
Elbow flexion and extension, and wrist flexion and extension stretching exercises.
Elbow and wrist strengthening exercises.
Grip strengthening exercises.
This will be applied for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Status
Time Frame: After the six-week intervention
|
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable).
The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.
|
After the six-week intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Intensity
Time Frame: Baseline
|
Pain intensity will be measured using the visual analogue scale (VAS).
The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain.
The score will be determined by measuring the distance on 10 cm line using a ruler.
The higher scores indicate an higher level of pain.
|
Baseline
|
Pain Intensity
Time Frame: After the six-week intervention
|
Pain intensity will be measured using the visual analogue scale (VAS).
The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain.
The score will be determined by measuring the distance on 10 cm line using a ruler.
The higher scores indicate an higher level of pain.
|
After the six-week intervention
|
Pain Intensity
Time Frame: 6-week follow-up
|
Pain intensity will be measured using the visual analogue scale (VAS).
The participants will be asked to indicate their perceived pain at rest, during activity and at night on the 10 cm line between no pain and terrible pain.
The score will be determined by measuring the distance on 10 cm line using a ruler.
The higher scores indicate an higher level of pain.
|
6-week follow-up
|
Active Range of Motion (AROM) Assessment
Time Frame: Baseline
|
The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer.
The process will be repeated three times in each direction, with the average value recorded.
|
Baseline
|
Active Range of Motion (AROM) Assessment
Time Frame: After the six-week intervention
|
The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer.
The process will be repeated three times in each direction, with the average value recorded.
|
After the six-week intervention
|
Active Range of Motion (AROM) Assessment
Time Frame: 6-week follow-up
|
The elbow's and forearm's AROM, including flexion, extension, supination, pronation will be measured described by the American Academy of Orthopaedic Surgeons (AAOS) using a universal goniometer.
The process will be repeated three times in each direction, with the average value recorded.
|
6-week follow-up
|
Functional Status
Time Frame: Baseline
|
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable).
The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.
|
Baseline
|
Functional Status
Time Frame: 6-week follow-up
|
The functional status of the patients will be evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH).
It comprises 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable).
The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.
|
6-week follow-up
|
Fear of movement (kinesiophobia)
Time Frame: Baseline
|
Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia.
It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree).
The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.
|
Baseline
|
Fear of movement (kinesiophobia)
Time Frame: After the six-week intervention
|
Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia.
It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree).
The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.
|
After the six-week intervention
|
Fear of movement (kinesiophobia)
Time Frame: 6-week follow-up
|
Kinesiophobia of the patients will be assessed by Tampa Scale for Kinesiophobia.
It is a 17-item questionnaire scored on a 4-point Likert-type scale (strongly disagree-strongly agree).
The total score of the scale ranged from 17 to 68, with higher scores indicating more kinesiophobia.
|
6-week follow-up
|
Patient Satisfaction
Time Frame: After the six-week intervention
|
Patient satisfaction regarding improvement in elbow function will be assessed by the Global Rating of Change scale.
The participants will be asked to rate their condition after a six-week intervention period compared to baseline by indicating whether they have improved significantly, improved slightly, unchanged, deteriorated slightly, or deteriorated significantly in this study.
|
After the six-week intervention
|
Right-Left Discrimination
Time Frame: Baseline
|
Right-Left Discrimination will be assessed with Recognise™ application.
It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination').
The test will be repeated three times and average values will be recorded.
|
Baseline
|
Right-Left Discrimination
Time Frame: After the six-week intervention
|
Right-Left Discrimination will be assessed with Recognise™ application.
It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination').
The test will be repeated three times and average values will be recorded.
|
After the six-week intervention
|
Right-Left Discrimination
Time Frame: 6-week follow-up
|
Right-Left Discrimination will be assessed with Recognise™ application.
It tests the patients' ability to quickly and accurately recognise an image of a body area as either left or right ('Left/Right Discrimination').
The test will be repeated three times and average values will be recorded.
|
6-week follow-up
|
Vividness of Movement imagery Questionnaire-2 (VMIQ-2)
Time Frame: Baseline
|
The Vividness of Movement Imagery Questionnaire-2 (VMIQ-2) will be used to measure the vividness of imagery.
It comprises three subscales and 12 core questions that are scored on a 5-point Likert-type scale (Perfectly clear and as vivid (as normal vision or feel of movement) - No image at all, you only "know" that you are thinking of the skill).
The subscales scores (External Visual Imagery, Internal Visual Imagery, and Kinaesthetic imagery) are ranged from 1 to 60, where the higher scores indicate a decreased ability of vividness of imagery.
|
Baseline
|
Pain pressure threshold
Time Frame: Baseline
|
Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry.
The process will be repeated three times in each direction, with the average value recorded.
|
Baseline
|
Pain pressure threshold
Time Frame: After the six-week intervention
|
Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry.
The process will be repeated three times in each direction, with the average value recorded.
|
After the six-week intervention
|
Pain pressure threshold
Time Frame: 6-week follow-up
|
Pain pressure threshold of the elbow and soft tissue around the elbow will be evaluated by digital pressure algometry.
The process will be repeated three times in each direction, with the average value recorded.
|
6-week follow-up
|
Muscle strength
Time Frame: After the six-week intervention
|
Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors.
The process will be repeated three times in each direction, with the average value recorded.
|
After the six-week intervention
|
Muscle strength
Time Frame: 6-week follow-up
|
Isometric muscle strength will be measured with a handheld dynamometer for elbow flexors and extensors.
The process will be repeated three times in each direction, with the average value recorded.
|
6-week follow-up
|
Grip strength
Time Frame: After the six-week intervention
|
Grip strength will be assessed with JAMAR hydraulic hand dynamometer.
The process will be repeated three times in each direction, with the average value recorded.
|
After the six-week intervention
|
Grip strength
Time Frame: 6-week follow-up
|
Grip strength will be assessed with JAMAR hydraulic hand dynamometer.
The process will be repeated three times in each direction, with the average value recorded.
|
6-week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mendez-Rebolledo G, Gatica-Rojas V, Torres-Cueco R, Albornoz-Verdugo M, Guzman-Munoz E. Update on the effects of graded motor imagery and mirror therapy on complex regional pain syndrome type 1: A systematic review. J Back Musculoskelet Rehabil. 2017;30(3):441-449. doi: 10.3233/BMR-150500.
- Sawyer EE, McDevitt AW, Louw A, Puentedura EJ, Mintken PE. Use of Pain Neuroscience Education, Tactile Discrimination, and Graded Motor Imagery in an Individual With Frozen Shoulder. J Orthop Sports Phys Ther. 2018 Mar;48(3):174-184. doi: 10.2519/jospt.2018.7716. Epub 2017 Dec 19.
- Dilek B, Ayhan C, Yagci G, Yakut Y. Effectiveness of the graded motor imagery to improve hand function in patients with distal radius fracture: A randomized controlled trial. J Hand Ther. 2018 Jan-Mar;31(1):2-9.e1. doi: 10.1016/j.jht.2017.09.004. Epub 2017 Nov 6.
- Priganc VW, Stralka SW. Graded motor imagery. J Hand Ther. 2011 Apr-Jun;24(2):164-8; quiz 169. doi: 10.1016/j.jht.2010.11.002. Epub 2011 Feb 9.
- Birinci T, Razak Ozdincler A, Altun S, Kural C. A structured exercise programme combined with proprioceptive neuromuscular facilitation stretching or static stretching in posttraumatic stiffness of the elbow: a randomized controlled trial. Clin Rehabil. 2019 Feb;33(2):241-252. doi: 10.1177/0269215518802886. Epub 2018 Oct 10.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2019
Primary Completion (Actual)
October 1, 2020
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
May 29, 2019
First Submitted That Met QC Criteria
May 29, 2019
First Posted (Actual)
May 31, 2019
Study Record Updates
Last Update Posted (Actual)
July 2, 2021
Last Update Submitted That Met QC Criteria
June 30, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 141001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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, Postoperative
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on Graded Motor Imagery
-
University of ValenciaCompleted
-
Istanbul UniversityCompleted
-
St. Ambrose UniversityCompleted
-
VA Office of Research and DevelopmentRecruitingHome-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb AmputationsPhantom Limb PainUnited States
-
Inonu UniversityRecruiting
-
Inonu UniversityNot yet recruitingStroke | Motor Imagery | Action Observation Training | Graded Motor ImageryTurkey
-
Nuray AlacaRecruitingShoulder Impingement Syndrome | Shoulder PainTurkey
-
Nuray AlacaRecruiting
-
IRCCS San Camillo, Venezia, ItalyUnknown
-
Mohammed samirNot yet recruiting