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IRCT20230719058844N1 IRCT 2023-08-07 Tehran University of Medical Sciences Effects of dry needling plus static stretching on plantar flexors spasticity, alpha motor neuron excitability, and balance in patients with chronic stroke Effects of dry needling plus static stretching on plantar flexors spasticity, alpha motor neuron excitability, and balance in patients with chronic stroke 2023-08-23 anticipated 26 Complete https://irct.ir/trial/71395 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the participants were divided into two groups by a simple random method with the help of shuffling the closed envelopes (Cards or Envelopes Shuffling) which were prepared according to their number and one of the names of the intervention or control was written on it. All patients have the same chance of being placed in any of the two groups. This study is a double-blind study. In this study, due to the use of sham dry needling, patients in the control group will be blinded of their placement in the intervention and control groups. Also, the assessor is blinded of the control and intervention groups and only knows them as groups A and B. Only the interventionist is aware of the research events, Blinding description: The assessor is the researcher and during the evaluations, he is not aware of the grouping of the patients and only knows them into two groups A and B. The use of dry needling as a sham in the control group causes the patient to be blinded to being in the control or intervention group. 3 Chronic stroke patients. Intervention 1: Intervention group: Intervention:In the intervention group, in each treatment session, after dry needling for 60 seconds, 20 minutes of stretching (29) of the plantar flexor muscles are applied using the designed orthosis. The reason for the superiority of dry needling over stretching is the effects of dry needling on the reduction of acetylcholine available to the muscle, which can make stretching more effective and increase the range of stretching.A) Dry needlingFor dry needling, a sterile disposable needle (size 0.30mm x 0.50mm and brand SMC, Seoul, Korea) is used. The patient is asked to lie prone on the bed and hang the ankle over the edge of the bed, and the Fast in Fast Out technique is used on the medial and lateral head of the gastrocnemius muscle for 60 seconds (25). According to Figure 2, the exact location of the dry needle is determined by drawing a line to connect the center of the popliteal cavity to the heel, and two centimeters inside and outside the proximal third of this line, the needle enters the inner head and It becomes external to the gastrocnemius muscle (25). The depth of the needle is adjusted depending on the opinion of the therapist and the depth of the subcutaneous tissue of the patient. The number of treatment sessions for dry needling is done with a frequency of once a day, three times a week on alternate days, and for a week.b) Static tensionTo apply traction, an orthosis designed by a technical orthopedic expert is used. The upper plate of this orthosis is for placing the leg and the lower plate is for placing the sole of the foot. These two upper and lower plates are connected to each other by adjustable screws for range of motion. This orthosis can be adjusted in different ranges of the ankle joint (Figure No. 3). In order to perform stretching, the patient sleeps supine in a completely calm and relaxed position with straight knees. The patient is requested not to make any contraction in the ankle and the orthosis is adjusted in the maximum range of dorsiflexion in the ankle (31). The number of treatment sessions for stretching is performed with a frequency of once a day, five times a week, and for one week (53). Intervention 2: Control group: In the control group, in each treatment session, in addition to Sham dry needling in the form of 10 g monofilament for three sessions, static stretching for 20 minutes and for five sessions using an orthosis (36) is performed. The use of dry needling as a sham causes the patient to be blinded to being in the control or intervention group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mahdi Esmaeeli
3rd Floor, No 10, Rashidi َAlley, Meghdad St, Pirouzi Ave, Tehran
Tehran Iran (Islamic Republic of) 1766717194 +98 21 3317 0630 mesmaeeli@razi.tums.ac.ir Tehran University of Medical Sciences scientific Mahdi Esmaeeli
3rd Floor, No 10, Rashidi َAlley, Meghdad St, Pirouzi Ave, Tehran
Tehran Iran (Islamic Republic of) 1766717194 +98 21 3317 0630 mesmaeeli@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Men and women with chronic stroke At least 6 months after stroke onset MMAS≥1 for the ankle plantar flexor muscle group Ability to walk 10 meters independently with or without an assistive device Having no pain in lower limb No history of botox injection in the plantar flexor muscles in the last 3 months No contraindication for dry needling No history of other neuromuscular system disorders Ability to understand and follow the instructions Age between 40 to 65 years 40 years 65 years Both Passive ROM limitation of more than 10% in ankle dorsiflexion compared to the less involved leg. Non-cooperation in carrying out treatment protocols Absence of the person in two consecutive treatment sessions Inability to complete the pre and post assessments G81.1 Spastic hemiplegia Rehabilitation Rehabilitation Intervention group: Intervention:In the intervention group, in each treatment session, after dry needling for 60 seconds, 20 minutes of stretching (29) of the plantar flexor muscles are applied using the designed orthosis. The reason for the superiority of dry needling over stretching is the effects of dry needling on the reduction of acetylcholine available to the muscle, which can make stretching more effective and increase the range of stretching.A) Dry needlingFor dry needling, a sterile disposable needle (size 0.30mm x 0.50mm and brand SMC, Seoul, Korea) is used. The patient is asked to lie prone on the bed and hang the ankle over the edge of the bed, and the Fast in Fast Out technique is used on the medial and lateral head of the gastrocnemius muscle for 60 seconds (25). According to Figure 2, the exact location of the dry needle is determined by drawing a line to connect the center of the popliteal cavity to the heel, and two centimeters inside and outside the proximal third of this line, the needle enters the inner head and It becomes external to the gastrocnemius muscle (25). The depth of the needle is adjusted depending on the opinion of the therapist and the depth of the subcutaneous tissue of the patient. The number of treatment sessions for dry needling is done with a frequency of once a day, three times a week on alternate days, and for a week.b) Static tensionTo apply traction, an orthosis designed by a technical orthopedic expert is used. The upper plate of this orthosis is for placing the leg and the lower plate is for placing the sole of the foot. These two upper and lower plates are connected to each other by adjustable screws for range of motion. This orthosis can be adjusted in different ranges of the ankle joint (Figure No. 3). In order to perform stretching, the patient sleeps supine in a completely calm and relaxed position with straight knees. The patient is requested not to make any contraction in the ankle and the orthosis is adjusted in the maximum range of dorsiflexion in the ankle (31). The number of treatment sessions for stretching is performed with a frequency of once a day, five times a week, and for one week (53). Control group: In the control group, in each treatment session, in addition to Sham dry needling in the form of 10 g monofilament for three sessions, static stretching for 20 minutes and for five sessions using an orthosis (36) is performed. The use of dry needling as a sham causes the patient to be blinded to being in the control or intervention group. Hmax/Mmax. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: Using an electromyography device. H reflex latency. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: Using an electromyography device. Modified modified Ashworth scale (MMAS). Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: Score between 0-4 by assessor ( MMAS ). Ankle active range of motion. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: Goniometer. Ankle passive range of motion. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: Goniometer. Timed up and go test. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: Time measured by a chronometer. Quality of life. Timepoint: Before the intervention, after the intervention, one week after the intervention. Method of measurement: European quality of life questionnaire. Tehran University of Medical Sciences Approved 2023-07-18 Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o 3rd Floor, Rashidi Alley, Meghdad St, Pirouzi Ave Tehran Tehran Iran (Islamic Republic of)