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IRCT20260128068683N1 IRCT 2026-05-18 Tehran University of Medical Sciences Comparison of the effect of transcutaneous electrical nerve stimulation with and without dry needling on wrist flexors stiffness, motor function and motor neuron excitability in patients with chronic stroke Comparison of the effect of transcutaneous electrical nerve stimulation with and without dry needling on wrist flexors spasticity, motor function and motor neuron excitability in patients with chronic stroke 2026-02-19 anticipated 28 Recruiting https://irct.ir/trial/88830 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to groups using a permuted block randomization method using web-based randomization (www.sealedenvelope.com). Random allocation concealment method: Use of sequentially numbered, sealed, opaque envelopes, Blinding description: Patients will not know which treatment group they are assigned to (both groups will receive the same treatment except for dry needling, which the control group will receive as a sham). The outcome assessor and data analyst will also be unaware of the treatment and group each patient received. N/A Patients with chronic stroke. Intervention 1: Intervention group: Intervention group: Transcutaneous electrical nerve stimulation with a frequency of 100 Hz and a pulse duration of 200 microseconds for 30 minutes while the patient is in the supine position and two surface electrodes with dimensions of 4 and 6 cm are placed on the forearm muscle bundle with a distance of 2.5 cm. The current intensity will be based on the patient's sensation and will be twice the sensory threshold. After receiving electrical stimulation, dry needling of the wrist flexor muscles is received while the patient lies in a supine position and dry needling is used on the flexor carpi radialis and flexor carpi ulnaris muscle bundle. For both muscles, the desired area is first disinfected with alcohol and then Fast-in and Fast-out are performed for one minute for each muscle according to the method of Ansari et al. After that, patients perform routine exercise therapy (standard exercises based on neurodevelopmental treatment including functional mobility exercises, active range of motion, and stretching exercises). Intervention 2: Control group: Transcutaneous electrical nerve stimulation at a frequency of 100 Hz and a pulse duration of 200 μs for 30 minutes while the patient is in the supine position and two surface electrodes measuring 4 and 6 cm are placed on the forearm muscle bundle with a distance of 2.5 cm from each other. The current intensity will be based on the patient's sensation and will be twice the sensory threshold. After receiving electrical stimulation, the dry needle placebo will be applied to the wrist flexor muscles while the patient is lying in a supine position and the dry needle placebo will be applied to the same points as the intervention group via dry needle-like microfilaments on the flexor carpi radialis and flexor carpi ulnaris muscle bundle. For both muscles, the desired area is first disinfected with alcohol and then, according to the method of Ansari et al., Fast-in and Fast-out are performed for one minute for each muscle. After that, patients perform routine therapeutic exercises (standard exercises based on neurodevelopmental treatment including functional mobility exercises, active range of motion, and stretching exercises). Yes - There is a plan to make this available What will be shared: If published, the overall data (data related to all outcomes before and after the intervention) and its results will be published without disclosing the personal information of the participants. The results from the primary and secondary assessments will be presented as averages in the table. When: Access period starts 6 months after results are published. To whom: It will only be available to researchers working in academic and scientific institutions. Conditions: They can use the results obtained for review studies. Access is possible if academic and scientific responsibility is established. Where to obtain: Applicants can send their application to the researcher's email address: rakhshanim500@gmail.com How to obtain: The applicant can access the information by providing valid proof of academic affiliation to the university by sending this proof to the researcher's email. Comments:
public Mahla Rakhshani
Corner of Safi Alishah St., Shemiran Intersection., Enghelab St.
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 rakhshanim500@gmail.com Tehran University of Medical Sciences scientific Dr Noureddin Nakhostin Ansari
corner of Safi Alishah St., Enghelab St.
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7753 3939 nakhostin@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Hemiplegia due to ischemic stroke At least 6 months have passed since the stroke Spasticity severity of the wrist flexor muscles of the affected side according to the MMAS scale of at least 1 Age 40 to 70 years Ability to follow instructions 40 years 70 years Both Taking any medication that is effective in reducing spasticity. I67.9 Cerebrovascular disease, unspecified Rehabilitation Rehabilitation Intervention group: Intervention group: Transcutaneous electrical nerve stimulation with a frequency of 100 Hz and a pulse duration of 200 microseconds for 30 minutes while the patient is in the supine position and two surface electrodes with dimensions of 4 and 6 cm are placed on the forearm muscle bundle with a distance of 2.5 cm. The current intensity will be based on the patient's sensation and will be twice the sensory threshold. After receiving electrical stimulation, dry needling of the wrist flexor muscles is received while the patient lies in a supine position and dry needling is used on the flexor carpi radialis and flexor carpi ulnaris muscle bundle. For both muscles, the desired area is first disinfected with alcohol and then Fast-in and Fast-out are performed for one minute for each muscle according to the method of Ansari et al. After that, patients perform routine exercise therapy (standard exercises based on neurodevelopmental treatment including functional mobility exercises, active range of motion, and stretching exercises). Control group: Transcutaneous electrical nerve stimulation at a frequency of 100 Hz and a pulse duration of 200 μs for 30 minutes while the patient is in the supine position and two surface electrodes measuring 4 and 6 cm are placed on the forearm muscle bundle with a distance of 2.5 cm from each other. The current intensity will be based on the patient's sensation and will be twice the sensory threshold. After receiving electrical stimulation, the dry needle placebo will be applied to the wrist flexor muscles while the patient is lying in a supine position and the dry needle placebo will be applied to the same points as the intervention group via dry needle-like microfilaments on the flexor carpi radialis and flexor carpi ulnaris muscle bundle. For both muscles, the desired area is first disinfected with alcohol and then, according to the method of Ansari et al., Fast-in and Fast-out are performed for one minute for each muscle. After that, patients perform routine therapeutic exercises (standard exercises based on neurodevelopmental treatment including functional mobility exercises, active range of motion, and stretching exercises). Spasticity severity. Timepoint: Before the start of the intervention, 7 and 28 days after the start of the intervention. Method of measurement: Modified Modified Ashworth Scale. Active range of motion of the wrist. Timepoint: Before the start of the intervention, 7 and 28 days after the start of the intervention. Method of measurement: Goniometer. Active range of motion of the wrist. Timepoint: Before the start of the intervention, 7 and 28 days after the start of the intervention. Method of measurement: Goniometer. Motor function. Timepoint: Before the start of the intervention, 7 and 28 days after the start of the intervention. Method of measurement: Box and Block Test. Motor neuron excitability. Timepoint: Before the start of the intervention, 7 and 28 days after the start of the intervention. Method of measurement: Electromyography device. H reflex latency. Timepoint: Before the start of the intervention, 7 and 28 days after the start of the intervention. Method of measurement: Electromyography device. Tehran University of Medical Sciences Approved 2025-06-14 Ethics committee of Tehran University of Medical Sciences Faculty of Rehabilitation of Tehran University of Medical Sciences, Corner of Safi Alishah St., Enghelab St. Tehran Tehran Iran (Islamic Republic of)