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IRCT20200904048609N1 IRCT 2020-09-23 Shiraz University of Medical Sciences Effect of dry needling technique on spastic upper extremity muscles in patients with chronic ischemic stroke Effect of dry needling technique on clinical, sonographic and biomechanical parameters of spastic upper extremity muscles in patients with chronic ischemic stroke 2020-11-14 anticipated 24 Complete https://irct.ir/trial/50763 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly divided into two equal groups by using of stratified permutation blocks method, with a block size of 4 by using of random allocation software, Blinding description: The treatment will be performed by a physiotherapist and all variables will be measured by another physiotherapist who is unaware of the allocated groups, and the data will be analyzed by a statistician who is unaware of the group assignments. N/A Ischemic stroke. Intervention 1: Intervention group: The intervention consists of 12 sessions (4 weeks, 3 sessions per week) routine physiotherapy treatment for stroke patients, including FES and exercise therapy for at least 40 minutes; And 4 sessions of dry needling treatment on FCU and FCR and FDP muscles once a week. Intervention 2: Control group: The intervention consists of 12 sessions (4 weeks, 3 sessions per week) routine physiotherapy treatment for stroke patients, including FES and exercise therapy for at least 40 minutes; And 4 sessions of sham dry needling treatment on FCU and FCR and FDP muscles once a week. Yes - There is a plan to make this available What will be shared: After coordination with the Research Ethics Committee for approval of the ethics committee, participants data file will be provided In complete secrecy and for research purposes only. When: 6 month after acceptance of the article by the journal. To whom: In addition to the principal researcher and the supervisor of the project, upon request, access to information can be reviewed by the Ethics Committee. Conditions: Preferably it is only used for the subject of my research, but if research is to be done in order to use the statistical population, the main project executor and the student's main collaborator will make a decision with the permission of the ethics committee. Where to obtain: Executors of the project can first be referred to through Dr. Zahra Rojhani Shirazi (09171127108), and the main colleague and student collaborator Ms Fatemeh Panahi (09183571646). How to obtain: 6 months after the article was published, referring the request to the executor of the project, in addition, an official letter from the ethics committee will be commented on in order to obtain a license, and if the ethics committee approves, emphasizing the confidentiality of the information, the requested information will be provided to the applicant. Comments:
public Fatemeh Panahi
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 fatemeh.panahi85@gmail.com Shiraz University of Medical Sciences scientific Fatemeh Panahi
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 fatemeh.panahi@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 35-65 years old Stroke occurrence for first time History of stroke onset at least 6 months and maximum of 2 years prior to the study Spasticity existence in the wrist and fingers flexor muscles ( +1 to 3 based on the modified Ashworth scale) Not taking any antispasmodics during the study for at least one month before the study beginning Having minimal grip ability Ability to understand and follow commands Absence of cognitive impairment (Mini-Mental State Examination score >24) 35 years 65 years Both Recurrent stroke Having other neurological diseases Cervical radiculopathy Fixed contracture in wrist and finger muscles Treatment with other therapies during this study History of physiotherapy treatments in less than a month prior to study History of treatment with dry needling technique after a stroke Previous treatment with nerve blocks or neurolytic agents injection in motor point or Infiltration of botulinum toxin At any time after stroke Uncontrolled hypertension Uncontrolled diabetes Upper limb fracture Any absolute contraindication for using of deep dry needling (such as pregnancy, infection, coagulation defect, seizures or mental disorders, and fear of needles) Reluctance to continue participating in the study I63 Cerebral infarction Rehabilitation Rehabilitation Intervention group: The intervention consists of 12 sessions (4 weeks, 3 sessions per week) routine physiotherapy treatment for stroke patients, including FES and exercise therapy for at least 40 minutes; And 4 sessions of dry needling treatment on FCU and FCR and FDP muscles once a week. Control group: The intervention consists of 12 sessions (4 weeks, 3 sessions per week) routine physiotherapy treatment for stroke patients, including FES and exercise therapy for at least 40 minutes; And 4 sessions of sham dry needling treatment on FCU and FCR and FDP muscles once a week. Spasticity. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Modified Ashworth scale. Muscle thickness of FCU, FCR and FDP; Separately for each muscle, and generally for flexor group. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Sonography. Flexor muscles compressibility. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Sonography. Wrist reflex torque. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Isokinetic machine. Wrist peak torque. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Isokinetic machine. Upper limb motor function. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Fugl-Meyer scale. Upper limb skill. Timepoint: Before treatment, after the last treatment session, 1 month after the last treatment sessions. Method of measurement: Box and block test. Shiraz University of Medical Sciences Approved 2020-08-19 Research Ethics Committee of Shiraz University of Medical Sciences School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran Shiraz Fars Iran (Islamic Republic of)