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IRCT20211030052912N7 IRCT 2026-08-03 Tehran University of Medical Sciences Evaluation of histological changes in the biceps brachii muscle after dry needling in stroke patients Evaluation of histological changes in the biceps brachii muscle after dry needling in stroke patients using theechovariation index: a double-blind Randomized clinical trial 2026-08-20 anticipated 39 Recruiting https://irct.ir/trial/92123 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Health service research, Randomization description: Randomization will be carried out via the website www.sealedenvelope.com.In this method, 5 blocks of 6 will be determined according to three groups. Then, each sequence will be recorded on a card and placed inside an envelope. In the order of patients' arrival, the envelopes will be opened and the assigned group of that participant will be determined. In this double-blind study, patients and the evaluator will be unaware of the type of group assigned. Randomization and evaluation will be carried out by a person who is not involved in the treatment process of the patients and is unaware of the type of intervention, Blinding description: In this double-blind study, patients and the evaluator are unaware of the type of group assigned. Randomization and evaluation will be performed by a person who is not involved in the treatment process of the patients and is unaware of the type of intervention. For the sham needle, a monofilament head, which is plastic and resembles a shoe, will be used that is only moved slowly over the skin and does not penetrate into the tissue. N/A Stroke. Intervention 1: Intervention group 1: will receive ten sessions of therapeutic exercise with the Bobath approach and five sessions of dry needling of the biceps muscle (every other session). Method of dry needling of the biceps muscle: the patient is placed in a supine position with the upper limb beside the body and the elbow in extension. Five centimeters above the middle of the elbow crease line (distal one-third of the muscle), the needle is inserted perpendicularly into the motor point of the muscle and moved for 1 minute in a fast in/fast out manner in different directions in a conical pattern. Intervention 2: Intervention group2:Will receive only five sessions of dry needling of the biceps muscle with intervals similar to the previous groups. Intervention 3: Control group:Ten sessions of therapeutic exercise with the Bobath approach, along with five sessions of sham needling of the biceps muscle (every other session), will be administered at the same previous points. For the sham needling, a plastic monofilament tip similar to a needle will be used, which is only slowly moved over the skin and does not penetrate the tissue. Yes - There is a plan to make this available What will be shared: After de-identifying people, the consent form and evaluation data can be shared. When: One year after the article was published To whom: Researchers working in educational, research and academic institutions Conditions: For the purpose of conducting research, with obtaining permission, attributing the source, and maintaining data confidentiality. Where to obtain: Email, phone number How to obtain: One week after sending an email or making a phone call Comments:
public Somaye azarnia
Dr. Heshmat Hospital, 15 Khordad Blvd., Rasht
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 9066 azarnia.pt.82@gmail.com Rasht University of Medical Sciences scientific Somaye Azarnia
Dr. Heshmat Hospital,15 Khordad Blvd.,Rasht
Rasht Iran (Islamic Republic of) 4193955588 +98 13 3366 9066 azarnia.pt.82@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) 1 Hemiplegia due to first ischemic stroke Age between 40 and 65 years At least 6 months after stroke Spasticity severity 1 or higher in elbow flexor muscles No use of anti-spasticity drugs during the study period No other nervous system disorders 40 years 65 years Both Having a second stroke Unwanted to continue cooperation 163 Cerebral infarctionIncl.:occlusion and stenosis of cerebral and precerebral arteries (including truncus brachiocephalicus), resulting in cerebral infarction Rehabilitation Rehabilitation Rehabilitation Intervention group 1: will receive ten sessions of therapeutic exercise with the Bobath approach and five sessions of dry needling of the biceps muscle (every other session). Method of dry needling of the biceps muscle: the patient is placed in a supine position with the upper limb beside the body and the elbow in extension. Five centimeters above the middle of the elbow crease line (distal one-third of the muscle), the needle is inserted perpendicularly into the motor point of the muscle and moved for 1 minute in a fast in/fast out manner in different directions in a conical pattern. Intervention group2:Will receive only five sessions of dry needling of the biceps muscle with intervals similar to the previous groups. Control group:Ten sessions of therapeutic exercise with the Bobath approach, along with five sessions of sham needling of the biceps muscle (every other session), will be administered at the same previous points. For the sham needling, a plastic monofilament tip similar to a needle will be used, which is only slowly moved over the skin and does not penetrate the tissue. . Timepoint: . Method of measurement: . Echovariance index. Timepoint: Before starting the intervention, after the treatment ends, and one week after the completion of the sessions. Method of measurement: Ultrasound and multifrequency linear transducers with a maximum frequency of 11 MHz will be used. Rang of motion. Timepoint: Before starting the intervention, after the treatment ends, and one week after the completion of the sessions. Method of measurement: By standard goniometer model COMED. Functional assessment. Timepoint: Before starting the intervention, after the treatment ends, and one week after the completion of the sessions. Method of measurement: Upper limb function is evaluated according to the Brunnstrom stages of recovery. Tehran University of Medical Sciences Approved 2026-07-27 Ethics committee of Tehran University of Medical Sciences Keshavarz Blvd., Corner of Qods, Headquarters of Tehran University of Medical Sciences, 6th Floor Tehran Tehran Iran (Islamic Republic of)