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IRCT20210702051758N1 IRCT 2021-08-21 University of Lahore Effects of neuromuscular electrical stimulation on motor function of hand in hemiplegic ischemic chronic stroke patients: A randomized controlled trial Effects of neuromuscular electrical stimulation on motor function of hand in hemiplegic ischemic chronic stroke patients: A randomized controlled trial 2020-07-01 anticipated 144 Complete https://irct.ir/trial/57291 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: Randomization of the sample with single blinded study and allocation by sealed envelops, Randomization description: Randomization was done using simple random sampling technique. Individual sampling was done with sealed envelops as tools for randomization. Random sequence was built by chit pull method. Allocation concealment was done, Blinding description: This is a single blinded study. In this study only the participants are kept unaware of the group in which they will be placed. N/A Stroke. Intervention 1: Control group: the control group will receive routine physical therapy for half hour a day,5 days a week, for 4 weeks. Activities of daily living will be performed to enhance motor function. Intervention 2: Intervention group: intervention group will receive neuromuscular electrical stimulation in addition to routine physical therapy for half hour. A total of 1 hour therapy session will be given daily, 5 days a week for 4 weeks. A NMES device will be used with a pair of surface electrodes. Indifferent electrode will be secured on the upper arm of the patient while active electrode will be placed on dorsum and volar aspect of hand for 15 minutes each. the frequency of stimulation will be set on 30 Hz. After stimulation, the group will receive routine therapy for another 30 minutes. 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 there is no further information
public Faiza Shareef
1-KM Defence road, Lahore
Lahore Pakistan 54000 +92 924 2111856 anamraza2august@gmail.com University of Lahore scientific Faiza Sharif
1-KM Defence road, Lahore
Lahore Pakistan 54000 +92 924 2111856 anamraza2august@gmail.com University of Lahore Pakistan 1.Hemiplegic patients having single episode of ischemic chronic stroke diagnosed by the neurologist. Male and female patients between 40 to 60 years of age. Duration of stroke, more than 6 months with spastic paralysis. Participants with no prior physical therapy session for the issue under study. .Participants should be able to understand and follow simple verbal instructions (Mini-Mental Status Examination [MMSE]≥24). 20 years 40 years Both 1.Participants with unstable condition I.e, recurrent stroke. History of congenital deformities and comorbidities. Presence of contractures in the limb under study. Implanted electrical devices(pacemaker, defibrillator etc). Participant of another research trial. I63.9 Cerebral infarction, unspecified Rehabilitation Rehabilitation Control group: the control group will receive routine physical therapy for half hour a day,5 days a week, for 4 weeks. Activities of daily living will be performed to enhance motor function. Intervention group: intervention group will receive neuromuscular electrical stimulation in addition to routine physical therapy for half hour. A total of 1 hour therapy session will be given daily, 5 days a week for 4 weeks. A NMES device will be used with a pair of surface electrodes. Indifferent electrode will be secured on the upper arm of the patient while active electrode will be placed on dorsum and volar aspect of hand for 15 minutes each. the frequency of stimulation will be set on 30 Hz. After stimulation, the group will receive routine therapy for another 30 minutes. Fugal meyer motor assessment scale. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: functional tasks will be performed. Hand held dynamometer. Timepoint: before the intervention and 4 weeks after intervention. Method of measurement: Hand held dynamometer. University of Lahore Approved 2021-02-25 Ethics committee of University of Lahore 1-km Defence road, Lahore Lahore Punjab Pakistan