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IRCT20180611040061N1 IRCT 2020-05-17 Tehran University of Medical Sciences Effect of dry needling with exercise therapy on stroke spasticity Effects of Dry Needling and Exercise Therapy on Post-Stroke Spasticity and Motor Function– A Randomized Clinical Trial 2020-11-20 anticipated 24 Complete https://irct.ir/trial/43034 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomly assign the patients, the opaque envelopes will be prepared containing the assigned terms "dry needling" or "dry needling+ exercise therapy" interventions. The secretary of the clinic will be choosing an envelope randomly, Blinding description: This is a single-blind clinical trial in which a expert physiotherapist will perform intervention and other physiotherapists will perform the Assessment. As a result, the Assessor will not know which group the patient belongs to. N/A Chronic stroke. Intervention 1: Intervention group: In the treatment group, patients will receive exercise therapy in addition to dry needle. Immediately after dry needle, patients will do exercises in Structure, Function, and Activity levels to mobilize wrist and finger joints to relieve muscle strength imbalance and gain motor control of affected limb and improve performance for 30 to 45 minutes, once a week, for a total of 4 weeks. The same exercises will be performed once a day at home and if they are unable to fully perform each exercise, the therapist in the clinic and a person at home will help the patients. Intervention 2: Control group: The control group will only receive dry needle intervention. Dry needle treatment will be administered once a week for 4 weeks. Patients in this group will continue their previous activities throughout life without any changes. Yes - There is a plan to make this available What will be shared: If needed by researchers and their request, the raw data of research and it's analysis will be available to researchers When: After the publication of articles resulting from the research To whom: Researchers working in academic institutions Conditions: The data are available only to other researchers to study and evaluate treatment outcomes. Where to obtain: By sending an email to the corresponding author How to obtain: Email the corresponding author and request the data Comments:
public Nastaran Ghotbi
Department of Physiotherapy, Faculty of Rehabilitation Sciences, Enghelab Ave.
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5132 nghotbi@tums.ac.ir Tehran University of Medical Sciences scientific Seyedeh Saeideh Babazadeh
Department of Physiotherapy, Faculty of Rehabilitation Sciences, Enghelab Ave.
Tehran Iran (Islamic Republic of) 1148956111 +98 21 7753 5132 babazadehpt89@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Documented diagnosis of stroke by a neurologist At least 6 months have passed since the stroke Age>40 years Being the first time stroke leading to hemiplegia Spasticity greater than one for wrist flexor muscles based on MMAS scale Absence of sensory disorders, bleeding, upper limb malignancies, ulcers and infection Ability to understand therapist and evaluator instructions Full consent to participate in the research 40 years no limit Both Fear of applying dry needles Having contracture in hand Contraindication for dry needling Other neurological lesions Having Diabetes Any history of treatment with nerve blockers such as botulinum toxin A 6 months prior to inclusion I63.9 Cerebral infarction, unspecified Rehabilitation Rehabilitation Intervention group: In the treatment group, patients will receive exercise therapy in addition to dry needle. Immediately after dry needle, patients will do exercises in Structure, Function, and Activity levels to mobilize wrist and finger joints to relieve muscle strength imbalance and gain motor control of affected limb and improve performance for 30 to 45 minutes, once a week, for a total of 4 weeks. The same exercises will be performed once a day at home and if they are unable to fully perform each exercise, the therapist in the clinic and a person at home will help the patients. Control group: The control group will only receive dry needle intervention. Dry needle treatment will be administered once a week for 4 weeks. Patients in this group will continue their previous activities throughout life without any changes. Wrist flexors spasticity. Timepoint: Measurement of Spasticity before and after the intervention (4 weeks after intervention) and 3 weeks after the intervention. Method of measurement: Persian version of Modified Modified Ashworth Scale. Alpha motor neuron excitability. Timepoint: Before and after intervention (4 weeks after intervention) and 3 weeks after intervention. Method of measurement: Electromyography machine (EMG). Range of motion. Timepoint: Before and after intervention (4 weeks after intervention) and 3 weeks after intervention. Method of measurement: Goniometer. Motor function. Timepoint: Before and after intervention (4 weeks after intervention) and 3 weeks after intervention. Method of measurement: Study of patients motor function with Fugl-Meyer Scale and Action Research Arm Test. Tehran University of Medical Sciences Approved 2020-04-28 Ethics committee of Tehran University of Medical Sciences School of Rehabilitation Sciences, Enghelab Ave., Tehran Tehran Tehran Iran (Islamic Republic of)