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The study is planned to include a minimum of 26 patients with paralytic poliomyelitis who meet the PPS diagnostic criteria (1). Patients will be randomized into two groups, and one group will receive only the exercise therapy used in standard treatment, while the other group will receive Transcranial Magnetic Stimulation (TMS) therapy in addition to exercise. TMS will be applied to the study group 5 times a week for 2 weeks, for a total of 10 sessions. The protocol to be applied during the study will be set to 1 Hz, and each session will last 15 minutes. All participants will be evaluated with muscle strength (manual muscle testing), 6-minute walking test, polio-related problems inventory, VAS pain, VAS fatigue, fatigue severity scale, Beck Depression Inventory, Nottingham health profile scales before, at the end of treatment, and at the end of the 3rd month. As a result of the evaluation, the potential positive effects of TMS on patients with PPS will be measured and evidence-based data for the use of this treatment modality in patients with PPS will be obtained. This study will be the first to evaluate the effectiveness of TMS in a controlled manner in a patient group with PPS. As a result of the evaluation, the potential positive effects of TMS on patients with PPS will be measured and evidence-based data will be obtained for the use of this treatment modality in patients with PPS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHAM | Sham Comparator | 5 sessions per week; 2 weeks, 90% RMT (resting motor threshold), 1 Hz, 15 min TMS will be applied, but treatment During the procedure, the application head of the device is turned in the opposite direction so that the patient receives TMS treatment. effect, but you hear the operating sound of the device and will spend it in the laboratory Also, home exercise program: quadriceps strengthening and knee isometric exercises |
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| INTERVENTION | Experimental | 5 sessions/week, 2 weeks, 90% RMT (resting motor threshold), 1 Hz, 15 min TMS application to patients As the application point, the Cz point on the EEG map, contralateral to the affected extremity, will be taken Also, home exercise program: quadriceps strengthening and knee isometric exercises |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | Magstim ,Rapid 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walk test | It is a test used to assess the level of functional exercise or functional capacity. The patient is asked to walk, but not run, in a 25 m long corridor at the highest possible speed without stopping. At the end of 6 minutes, the number of metres walked by the patient is recorded. The 6 min walk test is an evaluation criterion used in routine and clinical research to assess functional capacity in many diseases such as heart failure, general arthrosis, multiple sclerosis. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported ımpairments in persons with late effects of polio (SIPP) rating scale | It consists of 13 items about PRI that the participants might have been bothered during the past 2 weeks: muscle weakness, muscle fatigue, muscle, and/or joint pain during physical activity and at rest, sensory disturbance, breathing difficulties at rest and during physical activity, cold intolerance, general fatigue, sleep disturbances, concentration difficulties, memory difficulties, and mood swings. The respondents are asked to rate each item as; 1: not at all, 2: little, 3: quite a bit 4: extremely, giving a total sum score ranging from 13 to 52 points. A higher score indicates more self-reported impairments |
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Inclusion Criteria:-Having been diagnosed with PPS (postpolio syndrome) -Having not received TMS treatment before
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Exclusion Criteria:-History of epilepsy
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| Name | Affiliation | Role |
|---|---|---|
| Arzu On, Prof.Dr | Ege Universtiy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University Faculty of Medicine | Izmir | BORNOVA | 35100 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30955403 | Background | Altas EU, Askin A, Besiroglu L, Tosun A. Is high-frequency repetitive transcranial magnetic stimulation of the left primary motor cortex superior to the stimulation of the left dorsolateral prefrontal cortex in fibromyalgia syndrome? Somatosens Mot Res. 2019 Mar;36(1):56-62. doi: 10.1080/08990220.2019.1587400. Epub 2019 Apr 8. | |
| 26319963 |
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| ID | Term |
|---|---|
| D016262 | Postpoliomyelitis Syndrome |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
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| 2 weeks |
| Nottingham health profile (NHP) | It consists of 38 items assessing how severe an impact the respondent thinks their health is having on six dimensions: sleep, physical mobility, energy, pain, emotional reactions, and social isolation. Every item has a different weight, depending on the severity of the symptom. The sum of the weighted scores is 100 for each subdimension. Thus, summing all weighted values of every item, the score between 0 and 100 is obtained for each subdimension. The total score was obtained by summing the scores of six subdimensions, giving the values between 0 and 600. Higher scores indicate a greater level of distress | 2 weeks |
| Visual analogue scale (VAS) for pain and fatigue | Severity of pain that the participants have had in the past week was evaluated by using visual analogue scale (VAS) on a 10-cm horizontal line where 0-cm represented "no pain" and 10 cm the "worst imaginable pain" Severity of fatigue experienced by the participants in the past week was assessed by using VAS on a 10-cm horizontal line where 0-cm represented "not tired at all" and 10-cm "extremely tired" | 2 weeks |
| Manual muscle testing (MMT) | Muscle strength of the hip flexors, knee extensors, knee flexors, ankle dorsiflexors, and plantar flexors were measured bilaterally according to the Medical Research Council Scale . A sum score (manual muscle testing [MMT] sum) was obtained by adding the scores of all muscle groups tested (max score: 50) | 2 weeks |
| Fatigue Impact Scale (FIS) | Cognitive, functional and fatigue subscales are available and high scores are associated with poor fatigue level. The scale is scored from 0 to 120 points. | 2 weeks |
| Beck Depression Scale | The Beck depression test is used to measure how intensely depressed a person is during a 1-week period.21 questions; each question is scored between 0 and 3. The degree of depression is determined according to the total score (0-9: minimal depression, 10-16: mild depression, 17-29: moderate depression, 30-63: severe depression). | 2 weeks |
| Klomjai W, Katz R, Lackmy-Vallee A. Basic principles of transcranial magnetic stimulation (TMS) and repetitive TMS (rTMS). Ann Phys Rehabil Med. 2015 Sep;58(4):208-213. doi: 10.1016/j.rehab.2015.05.005. Epub 2015 Aug 28. |
| 11955992 | Background | Ertekin C, On AY, Kirazli Y, Kurt T, Gurgor N. Motor evoked responses from the thigh muscles to the stimulation of the upper limb nerves in patients with late poliomyelitis. Clin Neurophysiol. 2002 Apr;113(4):478-84. doi: 10.1016/s1388-2457(02)00043-3. |
| 32043852 | Background | Willen C, Hou L, Stibrant Sunnerhagen K. A very long-term longitudinal follow-up of persons with late effects of polio. Eur J Phys Rehabil Med. 2020 Apr;56(2):155-159. doi: 10.23736/S1973-9087.20.05918-3. Epub 2020 Feb 10. |
| 36169616 | Background | Latifoglou E, Cinar E, Tanigor G, On AY. Coexistence of fibromyalgia and post-polio syndrome in persons with prior poliomyelitis in Turkey: the relations with symptoms, polio-related impairments, and quality of life. Disabil Rehabil. 2023 Oct;45(21):3511-3518. doi: 10.1080/09638288.2022.2127931. Epub 2022 Sep 28. |
| D004769 |
| Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D019636 | Neurodegenerative Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |