Protocol summary
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Study aim
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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
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Design
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Single group before-after clinical trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Children and adolescents with type 1 diabetes, 7-18 years and a history of at least one year from onset
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Intervention groups
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Neuromuscular electrical stimulation protocol with the aim of creating muscle contraction consist of 40-minute sessions, 3 day per week for 8 weeks
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Main outcome variables
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serum glucose level
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2020-10-25, 1399/08/04
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-10, 1399/08/20
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Expected recruitment end date
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2021-05-10, 1400/02/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of Neuromuscular Electrical Stimulation on serum glucose level condition in Children and Adolescents with Type 1 Diabetes Mellitus
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Public title
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"Effect of Neuromuscular Electrical Stimulation on Type 1 Diabetes Mellitus"
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 7 years old to 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
35
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-09-26, 1399/07/05
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Ethics committee reference number
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IR.MUBABOL.REC.1399.298
Health conditions studied
1
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Description of health condition studied
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Type 1 diabetes mellitus
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ICD-10 code
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E10.9
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ICD-10 code description
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Type 1 diabetes mellitus without complications
Primary outcomes
1
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Description
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serum glucose level
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Timepoint
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Before the intervention, 2 and 6 weeks after the last session
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Method of measurement
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blood sample
Secondary outcomes
1
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Description
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HbA1c
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Timepoint
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Before the intervention, 2 and 6 weeks after the last session
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Method of measurement
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Blood sample
2
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Description
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The average weekly dose of total daily dose of insulin
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Timepoint
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daily
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Method of measurement
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Daily information form
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Babol University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available