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IRCT201202218629N1 IRCT 2013-03-27 Tehran University of Medical Sciences Treatment of Swallowing disorders in stroke patients TDT TMS Comparative Study of effectiveness of Combined treatment of dysphagia(Traditional Dysphagia Therapy &Transcranial Magnetic Stimulation) and other two treatments in Stroke Patients". 2012-06-21 anticipated 15 Complete https://irct.ir/trial/9123 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A Dysphagia. Intervention 1: Control Group : The first group are provided traditional dysphagia therapy. this protocol is included competional treatments , postural changes, oromotor exercies and swallowind manuers. this treatments is provided in 30 min for 3 days of week and for 6 weeks. Intervention 2: Intervention Group : The second group are provided inhibitory Repatative Transcranial Magnetic Stimulations (rTMS) in healty hemisphere. Stimulations were performed at 1 Hz for 20 min at 20% above the threshold value. It was repeate each day for 5 days. All stimulations were carried out using a Magstim superrapi stimulator (Magstim, Whitland, Dyfed, UK) equipped with a air-refreshed, double, 70-mm, figure-of-eight coil (peak magnetic field = 2 T), at the maximal output of the stimula. The vertex of the cranium was first identified. The coil was then positioned 2–4 cm anteriorlyand 4–6 cm laterally and moved around in this area to obtain the highest electromyographic mylohyoid response. Intervention 3: Intervention Group: The third group is given combined treatment(TDT and rTMS). Firstly patients are given rTMS for 5 day and Simultaneously are given TDT for 3days in week for 6 weeks. In every day that is provided two treatment Simultaneously patients are given rTMS for 20 min and after short rest (5-10 min) another treatment (TDT) is provided for 30 min by speech& language Pathologist.
public Leila Ghelichi
Speech therapy Department, Rehabilitation School, Shahnazari Street, Madar Squre, Mirdamad
Tehran Iran (Islamic Republic of) +98 21 2222 8051 l-ghelichi@razi.tums.ac.ir ,lghelichi@gmail.com Tehran University of Medical Sciences scientific Leila Ghelichi
Speech therapy Department, Rehabilitation School, Shahnazari Street, Madar Squre, Mirdamad
Tehran Iran (Islamic Republic of) +98 21 2222 8051 l-ghelichi@razi.tums.ac.ir ,lghelichi@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion Criteria: 1-Subacute(at least one week after the accuring of stroke) Stroke patient with dysphagia 2-Patients' rang of age is between 20-80 3-Patients from Both gender 4-Suffering from dysphagia and aspiration diagnosed by MASA(Mann Assessment of Swallowing Ability) 5- they have not received any Dysphagia therapy. Exclusion Criteria: 1- Dementia and Alzheimer and dysphagia due to other neurogenic Disease 2_ Significant reflux 3- Severe Aphasia 4_ Dysphagia due to drug toxicity 5- severe Reflux 6_ Agitation, with decreased level of consciousness, or otherwise noncompliant 7_ Pregnancy 20 years 80 years Both R13 Difficulty in swallowing Rehabilitation Treatment - Devices Rehabilitation Control Group : The first group are provided traditional dysphagia therapy. this protocol is included competional treatments , postural changes, oromotor exercies and swallowind manuers. this treatments is provided in 30 min for 3 days of week and for 6 weeks. Intervention Group : The second group are provided inhibitory Repatative Transcranial Magnetic Stimulations (rTMS) in healty hemisphere. Stimulations were performed at 1 Hz for 20 min at 20% above the threshold value. It was repeate each day for 5 days. All stimulations were carried out using a Magstim superrapi stimulator (Magstim, Whitland, Dyfed, UK) equipped with a air-refreshed, double, 70-mm, figure-of-eight coil (peak magnetic field = 2 T), at the maximal output of the stimula. The vertex of the cranium was first identified. The coil was then positioned 2–4 cm anteriorlyand 4–6 cm laterally and moved around in this area to obtain the highest electromyographic mylohyoid response. Intervention Group: The third group is given combined treatment(TDT and rTMS). Firstly patients are given rTMS for 5 day and Simultaneously are given TDT for 3days in week for 6 weeks. In every day that is provided two treatment Simultaneously patients are given rTMS for 20 min and after short rest (5-10 min) another treatment (TDT) is provided for 30 min by speech& language Pathologist Score of MASA test. Timepoint: Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment. Method of measurement: MASA test. Dysphagia. Timepoint: Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment. Method of measurement: MASA test. Severity of Dysphagia. Timepoint: Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment. Method of measurement: MASA test. Aspiration. Timepoint: Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment. Method of measurement: MASA test. Severity of Aspiration. Timepoint: Before treatment,5th session,10th session,the end of forth week of treatment and the end of sixth week of treatment. Method of measurement: MASA test. Tehran University of Medical Sciences Approved 2012-12-26 Tehran University of Medical Sciences Sixth floor, Center building of University, Qods street, Keshavarz Blvd Tehran Iran (Islamic Republic of)