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IRCT20250920067297N1 IRCT 2025-09-26 Iran University of Medical Sciences Comparing the effects of two treatment methods on phantom pain and prosthesis embodiment in unilateral lower limb amputees: using fMRI Comparing the Effects of Graded Motor Imagery Technique and Mirror Therapy on Phantom Pain and Prosthesis Embodiment in Unilateral Lower Limb Amputees: An fMRI Clinical Trial Study 2025-10-07 anticipated 20 Complete https://irct.ir/trial/86289 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this randomized controlled study, unilateral below-knee amputees who have phantom limb pain and have recently received their prosthesis will be invited to the study if they meet the inclusion criteria. These individuals will be randomly assigned to two intervention groups: GMI (intervention group) and mirror therapy (control group). Using a random number table, participants will be randomly assigned to each of the study groups by an independent researcher. Prior to randomization, the independent researcher will conduct the necessary assessments and complete the questionnaires, Blinding description: Participants in this study do not know whether they are in the GMI intervention group or the mirror therapy control group. This blinding helps to reduce psychological effects and patient expectations and prevents bias in reporting results. The researcher who assesses the results will also be unaware of the groups to which participants are assigned. The person performing the data analysis will also be unaware of the information regarding group assignment. N/A Traumatic Unilateral Below the knee Amputees. Intervention 1: Intervention group: The GMI group will undergo GMI intervention at least once a day for 6 weeks. The GMI technique has three stages, each stage lasting 2 weeks. Stage 1 (Determination of Laterality of the Involved Limb): Determining the imaged limb as right or left activates the premotor areas of the brain. For this purpose, several digital photos of the healthy limb of the person are taken in different positions and are mirrored using software to create similar images of the unamputated limb, and a bank of photos of the two limbs is created. Then, two-thirds of the photos in the bank are randomly selected and shown to the amputee on a monitor. The person is asked to say immediately after seeing the picture whether the image they see is of the right or left limb. At this stage, the speed and accuracy of the person's performance are emphasized. People are asked to do this 3 times a day (about 10 minutes each time) and after waking up at night. The duration of each test and the speed and accuracy of the performance will be recorded by software installed on the patient's Android mobile phone. Second stage (imaging limb movements): In this stage, several images of the amputated limb are randomly selected from the image bank and presented to the patient again randomly via computer. Subjects are asked to imagine moving their amputated limb to the position in the picture when they see the limb in the picture. In this phase, subjects are asked to do this 3 times (15 minutes) each time they wake up (the patient must be in a relaxed state during the test). In this stage, the emphasis is on imagining the amputated limb in the proper posture and the position of each toe. The duration of each test will be recorded in the software. Stage Three (Mirror Therapy): In this stage, a cardboard box divided into two parts by a vertical mirror will be used. A hard copy of several images of the healthy leg will be selected from the image bank and the patient will be asked to slowly and carefully align both legs with the images shown after each awakening (10 minutes). The affected leg in this test should be hidden behind a mirror and the emphasis at this stage is on looking at the reflection of the healthy leg in the mirror. Intervention 2: Control group: Patients will receive verbal and written instructions for the 6-week mirror therapy exercises in a face-to-face session before the training phase begins. Patients will be instructed to consciously associate the movement observed in the mirror with their imaginary limb at any time during the training period and to maintain their attention focused on this task. Each instruction will be explained verbally and then performed by the patients. In total, five different motor tasks will be designed to increase the patients' cooperation. These tasks include: (1) plantar and dorsiflexion of the ankle; (2) flexion and extension of fingers 2 through 5; (3) bringing the medial edge of the foot closer to the mirror; (4) flexion and extension of the big toe; (5) ankle rotation; (6) ankle inversion and eversion; and (7) smooth ankle and knee movements in the manner of a cyclist. All of these tasks will be designed to maximize the visibility of the movement. Yes - There is a plan to make this available What will be shared: Information on the primary and secondary outcomes will extract from the documentation and will share in the article. When: Access will be possible starting from the end of 2026, and after the article is published. To whom: Researchers in the relevant field and working in academic and scientific institutions can submit applications. Conditions: Only for conducting systematic studies or meta-analyses Where to obtain: Dr. Behnoosh Vasaghi School of Rehabilitation Sciences, Iran University of Medical Sciences mail: bvasaghi@gmail.com How to obtain: Send email, review request, and then send data. Comments:
public Amir Ali Gordahani
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Madadkaran st, Shahnazari st, Mirdamad Blv, Tehran.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 0947 amiraligordahani@gmail.com Iran University of Medical Sciences scientific Amir Ali Gordahani
Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Madadkaran st, Shahnazari st, Mirdamad Blv, Tehran.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 0947 amiraligordahani@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) -Unilateral below knee amputations -At least one-month after receiving prosthesis -At least 3 months after amputation -Obtaining a score of 4 or 5 on each of the questions in items 4 and 5 of the Kinesthetic and Visual Imagery Questionnaire (KVIQ) Questionnaire - Eigtheen to fifteen years old -Ability to read in Persian -Absence of cortical disorders -Absence of visual impairments -Absence of comorbidities 18 years 50 years Both -Failure to continue the GMI or mirror therapy intervention process until the end of the study -Failure to complete questionnaires -Presence of neuroma in the amputated limb -Participants with simultaneous upper limb amputations S88.11 Complete traumatic amputation at level between knee and ankle Rehabilitation Rehabilitation Intervention group: The GMI group will undergo GMI intervention at least once a day for 6 weeks. The GMI technique has three stages, each stage lasting 2 weeks. Stage 1 (Determination of Laterality of the Involved Limb): Determining the imaged limb as right or left activates the premotor areas of the brain. For this purpose, several digital photos of the healthy limb of the person are taken in different positions and are mirrored using software to create similar images of the unamputated limb, and a bank of photos of the two limbs is created. Then, two-thirds of the photos in the bank are randomly selected and shown to the amputee on a monitor. The person is asked to say immediately after seeing the picture whether the image they see is of the right or left limb. At this stage, the speed and accuracy of the person's performance are emphasized. People are asked to do this 3 times a day (about 10 minutes each time) and after waking up at night. The duration of each test and the speed and accuracy of the performance will be recorded by software installed on the patient's Android mobile phone. Second stage (imaging limb movements): In this stage, several images of the amputated limb are randomly selected from the image bank and presented to the patient again randomly via computer. Subjects are asked to imagine moving their amputated limb to the position in the picture when they see the limb in the picture. In this phase, subjects are asked to do this 3 times (15 minutes) each time they wake up (the patient must be in a relaxed state during the test). In this stage, the emphasis is on imagining the amputated limb in the proper posture and the position of each toe. The duration of each test will be recorded in the software. Stage Three (Mirror Therapy): In this stage, a cardboard box divided into two parts by a vertical mirror will be used. A hard copy of several images of the healthy leg will be selected from the image bank and the patient will be asked to slowly and carefully align both legs with the images shown after each awakening (10 minutes). The affected leg in this test should be hidden behind a mirror and the emphasis at this stage is on looking at the reflection of the healthy leg in the mirror. Control group: Patients will receive verbal and written instructions for the 6-week mirror therapy exercises in a face-to-face session before the training phase begins. Patients will be instructed to consciously associate the movement observed in the mirror with their imaginary limb at any time during the training period and to maintain their attention focused on this task. Each instruction will be explained verbally and then performed by the patients. In total, five different motor tasks will be designed to increase the patients' cooperation. These tasks include: (1) plantar and dorsiflexion of the ankle; (2) flexion and extension of fingers 2 through 5; (3) bringing the medial edge of the foot closer to the mirror; (4) flexion and extension of the big toe; (5) ankle rotation; (6) ankle inversion and eversion; and (7) smooth ankle and knee movements in the manner of a cyclist. All of these tasks will be designed to maximize the visibility of the movement. Phantom pain. Timepoint: Before and After the intervention. Method of measurement: TAPES questionnaire and VAS. Prosthesis Embodiment. Timepoint: Before and After the intervention. Method of measurement: PES questionnaire. Activity of cortical areas of the brain. Timepoint: Before and After the intervention. Method of measurement: fMRI. Duration of using the present prosthesis. Timepoint: Before the intervention. Method of measurement: Questionnaire. Time to amputaion. Timepoint: Before the intervention. Method of measurement: Questionnaire. Iran University of Medical sciences Approved 2025-09-17 Ethics committee of Iran University of Medical Sciences Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Madadkaran st, Shahnazari st, Mirdamad Blv, Tehran. Tehran Tehran Iran (Islamic Republic of)