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Primary outcomes
#1
Before the intervention and 2 weeks after the last session
Before the intervention, 2 and 6 weeks after the last session
Before the intervention, 2 and 26 weeks after the last session
قبل از شروع مداخله و ۲ هفته پس از آخرین جلسه ی مداخله
قبل از شروع مداخله، ۲ و ۶ هفته پس از آخرین جلسه ی مداخله
قبل از شروع مداخله، ۲ و ۲۶ هفته پس از آخرین جلسه ی مداخله
Secondary outcomes
#1
Before the intervention and 2 weeks after the last session
Before the intervention, 2 and 6 weeks after the last session
Before the intervention, 2 and 26 weeks after the last session
قبل از شروع مداخله و٢ ھفته پس از آخرین جلسه ی مداخله
قبل از شروع مداخله، ٢ و ۶ ھفته پس از آخرین جلسه ی مداخله
قبل از شروع مداخله، ٢ و٢ ۶ ھفته پس از آخرین جلسه ی مداخله
Protocol summary
Study aim
Effect of neuromuscular electrical stimulation on serum glucose level condition, HbA1c and total daily dose of insulin in children and adolescents with type 1 diabetes mellitus
Design
Single group before-after clinical trial
Settings and conduct
Children and adolescents with type 1 diabetes referred to the endocrinology clinic of Amirkola Children's Hospital are included in the study according to the inclusion criteria.
Participants/Inclusion and exclusion criteria
Children and adolescents with type 1 diabetes, 7-18 years and a history of at least one year from onset
Intervention groups
Neuromuscular electrical stimulation protocol with the aim of creating muscle contraction consist of 40-minute sessions, 3 day per week for 8 weeks
Main outcome variables
serum glucose level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100523003998N1
Registration date:2020-10-25, 1399/08/04
Registration timing:prospective
Last update:2021-01-27, 1399/11/08
Update count:1
Registration date
2020-10-25, 1399/08/04
Registrant information
Name
ghadamali talebi
Name of organization / entity
Babol univercity of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 4641
Email address
talebiali2@yahoo.co.in
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Neuromuscular Electrical Stimulation on serum glucose level condition in Children and Adolescents with Type 1 Diabetes Mellitus
Public title
"Effect of Neuromuscular Electrical Stimulation on Type 1 Diabetes Mellitus"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children and adolescents with type 1 diabetes with the age range of 7 to 18 years
History of at least one year from the onset of the disease
Exclusion criteria:
History of known neuromuscular diseases
History of convulsions and use of anticonvulsant drugs
Heart disease
Infectious diseases
Sensory disturbance
Intolerance to electrical stimulation
Other contraindications to the use of electrical stimulation
Professional athletes
Incidence of side effects
Age
From 7 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganjafroz street - Univercity square - Babol univercity of medical sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.MUBABOL.REC.1399.298
Health conditions studied
1
Description of health condition studied
Type 1 diabetes mellitus
ICD-10 code
E10.9
ICD-10 code description
Type 1 diabetes mellitus without complications
Primary outcomes
1
Description
serum glucose level
Timepoint
Before the intervention, 2 and 6 weeks after the last session
Method of measurement
blood sample
Secondary outcomes
1
Description
HbA1c
Timepoint
Before the intervention, 2 and 6 weeks after the last session
Method of measurement
Blood sample
2
Description
The average weekly dose of total daily dose of insulin
Timepoint
daily
Method of measurement
Daily information form
Intervention groups
1
Description
Intervention group:To apply neuromuscular electrical stimulation (NMES) the stimulator device of Novin, Made in Iran, model 710P PLUS will be used with the aim of creating muscle contraction in the form of a balanced two-phase pulsed current with parameters of frequency 35 Hz, duration 300 microsecond, with ratio on to off 1 to 3 with a time of 5 seconds on and 15 seconds off with an intensity that is tolerable in two stages of 20 minutes with an interval of 10 minutes between the two stages to prevent possible fatigue and discomfort of children. In the first stage, 4 electrodes (6cm.4cm) will be placed bilaterally on the Quadriceps muscle bulk on both the left and right sides. In order to activate the maximum muscle fibers, one electrode will be wrapped around the proximal and lateral and the other around the distal and medial part of the thigh. The second stage is similar to the first stage, and this time the electrodes will be placed on the bulk of the right and left Hamstring muscles. The NMES protocol consists of 40-minute sessions, 3 days per week, for 8 weeks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Hospital Of Amirkola
Full name of responsible person
Ghadamali Talebi
Street address
Ganjafrooz Street, Babol University Of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4645
Email
talebiali2@yahoo.co.in
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Ganjafrooz Street, Babol University Of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47367
Phone
+98 11 3219 0557
Email
hribabol@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Babol University of Medical Sciences
Full name of responsible person
Fatemeh Fallah
Position
master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Shahid Namjoo street, Shahid Namjoo 9
City
Fereydunkenar
Province
Mazandaran
Postal code
47518-86364
Phone
+98 11 3565 5730
Email
Saj.flh94@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ghadamali Talebi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ganjafrooz street, Babol University Of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4645
Email
talebiali2@yahoo.co.in
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ghadamali Talebi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ganjafrooz street, Babol University Of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 4645
Email
talebiali2@yahoo.co.in
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available