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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
26
Magstim ,Rapid 2
Ege University Faculty of Medicine
Izmir, BORNOVA, Turkey (Türkiye)
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.
Time frame: 2 weeks
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
Time frame: 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
Time frame: 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"
Time frame: 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)
Time frame: 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.
Time frame: 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).
Time frame: 2 weeks
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