Effects of neuromuscular electrical stimulation on motor function of hand in hemiplegic ischemic chronic stroke patients: A randomized controlled trial
The aim of the study is to find out
The effectiveness of neuromuscular electrical stimulation on motor function of hand in hemiplegic ischemic chronic stroke patients.
The effectiveness of neuromuscular electrical stimulation on strength of hand in hemiplegic ischemic chronic stroke patients.
Design
Randomized, parallel group with single blinded study. Sealed envelops were used.
Settings and conduct
the trial is conducted in Sheikh Zayed hospital, RYK. Single blinded study design is used in which all the participants are kept blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Hemiplegic patients having single episode of ischemic chronic stroke diagnosed by the neurologist.
Male and female patients between 40 to 60 years of age.39
Duration of stroke, more than 6 months with spastic paralysis.
Exclusion criteria:
Participants with unstable condition I.e., recurrent stroke.
Implanted electrical devices(pacemaker, defibrillator etc).
Intervention groups
control group will receive routine physical therapy. Experimental group will receive neuromuscular electrical stimulation in addition to routine physical therapy.
Main outcome variables
there are 2 main outcome variables
1.Fugl meyer motor assessment scale
2.Hand held dynamometer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210702051758N1
Registration date:2021-08-21, 1400/05/30
Registration timing:retrospective
Last update:2021-08-21, 1400/05/30
Update count:0
Registration date
2021-08-21, 1400/05/30
Registrant information
Name
anam raza
Name of organization / entity
University of Lahore, Pakistan
Country
Pakistan
Phone
+92 68 5873794
Email address
anamraza2august@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-01, 1399/04/11
Expected recruitment end date
2021-06-30, 1400/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of neuromuscular electrical stimulation on motor function of hand in hemiplegic ischemic chronic stroke patients: A randomized controlled trial
Public title
Effects of neuromuscular electrical stimulation on motor function of hand in hemiplegic ischemic chronic stroke patients: A randomized controlled trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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).
Exclusion criteria:
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.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Randomization of the sample with single blinded study and allocation by sealed envelops.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Lahore
Street address
1-km Defence road, Lahore
City
Lahore
Postal code
54000
Approval date
2021-02-25, 1399/12/07
Ethics committee reference number
IRB-UOL-FAHS/824/2021
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63.9
ICD-10 code description
Cerebral infarction, unspecified
Primary outcomes
1
Description
Fugal meyer motor assessment scale
Timepoint
before intervention and 4 weeks after intervention
Method of measurement
functional tasks will be performed
2
Description
Hand held dynamometer
Timepoint
before the intervention and 4 weeks after intervention
Method of measurement
Hand held dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikh Zayed hospital, Rahim Yar Khan
Full name of responsible person
Fozia Nawaz
Street address
Hospital road, Rahim Yar Khan
City
Rahim Yar Khan
Postal code
64200
Phone
+92 68 5873794
Email
anamraza2august@gmail.com
Web page address
http://www.gmail.com/.
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Asad Gillani
Street address
1-KM Defence road, Lahore
City
Lahore
Postal code
54000
Phone
+92 924 2111856
Email
anamraza2august@gmail.com
Web page address
http://www.gmail.com/.
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Lahore
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Faiza Shareef
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-KM Defence road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 924 2111856
Email
anamraza2august@gmail.com
Web page address
http://www.gmail.com/.
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Faiza Sharif
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-KM Defence road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 924 2111856
Email
anamraza2august@gmail.com
Web page address
http://www.gmail.com/.
Person responsible for updating data
Contact
Name of organization / entity
university of Lahore
Full name of responsible person
Anam Raza
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
H no.24, Teachers street, Fazeelat town, RYK
City
Rahim Yar Khan
Province
Punjab
Postal code
64200
Phone
+92 68 5873794
Email
anamraza2august@gmail.com
Web page address
http://www.gmail.com/.
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available