UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046401 |
|---|---|
| Receipt number | R000052945 |
| Scientific Title | The efficacy of neuromuscular electrical stimulation of calf muscles on nocturnal symptoms and quality of life of asthmatic children |
| Date of disclosure of the study information | 2021/12/17 |
| Last modified on | 2023/11/24 07:25:13 |
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Basic information
Public title
The efficacy of neuromuscular electrical stimulation of calf muscles on nocturnal symptoms and quality of life of asthmatic children
Acronym
The efficacy of neuromuscular electrical stimulation of calf muscles on nocturnal symptoms and quality of life of asthmatic children
Scientific Title
The efficacy of neuromuscular electrical stimulation of calf muscles on nocturnal symptoms and quality of life of asthmatic children
Scientific Title:Acronym
The efficacy of neuromuscular electrical stimulation of calf muscles on nocturnal symptoms and quality of life of asthmatic children
Region
| Africa |
Condition
Condition
asthma
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of the efficacy of neuromuscular electrical stimulation of calf muscles on nocturnal symptoms and quality of life of asthmatic children
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
nocturnal symptoms
Key secondary outcomes
quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The study group received neuromuscular electrical stimulation of calf muscles for 30min, three days a week for three months.
In addition to a specialized physical training exercise program for one hour, five days a week for three months.
Interventions/Control_2
a specialized physical training exercise program for one hour, five days a week for three months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 8 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- body mass index (BMI) < 25 kg/m2.
- clinically stable conditions (i.e., no canges in the medications were advised by the attending physician for > one month and taking maintained doses of drugs in the past 3 months).
Key exclusion criteria
- Aggravation of asthma symptoms that necessitate the use of systemic corticosteroids in the past month or during the study time
- Chronic sinusitis, history of thoracic surgery, respiratory co-morbidities that pose further ailments than asthma.
- Impairment of the cognitive function.
- Any recent calf strains, and compartmental leg syndrome
- Any medications such as muscle relaxants, histamines were excluded from the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Rasha |
| Middle name | abdelmoneim |
| Last name | Mohamed |
Organization
CAIRO UNIVERSITY
Division name
Department of Physical Therapy for Growth and Developmental Disorders in Children and its Surgery
Zip code
0000
Address
ahmed al zyaat, Giza, Egypt
TEL
00966508771352
dr.rashapt@gmail.com
Public contact
Name of contact person
| 1st name | Rasha |
| Middle name | |
| Last name | Mohamed |
Organization
Associate professor in the department of Physical Therapy for Growth and Developmental Disorders in
Division name
Department of Physical Therapy for Growth and Developmental Disorders in Children and its Surgery
Zip code
0000
Address
Burrydah, Al Qassim, Kingdom of Saudi Arabia
TEL
00966508771352
Homepage URL
dr.rashapt@gmail.com
Sponsor or person
Institute
CAIRO UIVERSITY
Institute
Department
Personal name
Funding Source
Organization
NO FUND
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Associate professor in the department of Physical Therapy for Growth and Developmental Disorders in
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
cairo university
Address
ahmed al zyaat, Giza, Egypt
Tel
00201284680606
dr.rashapt@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35647826/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35647826/
Number of participants that the trial has enrolled
60
Results
https://pubmed.ncbi.nlm.nih.gov/35647826/
Results date posted
| 2023 | Year | 11 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/35647826/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/35647826/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/35647826/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/35647826/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 28 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 17 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052945
