UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044102 |
|---|---|
| Receipt number | R000050363 |
| Scientific Title | Effect Two Different Rehabilitation Approaches on Pulmonary Measures, Neuromuscular Functions and Quality of Life in Juvenile Myasthenia Gravis: A controlled randomized study |
| Date of disclosure of the study information | 2021/05/04 |
| Last modified on | 2023/11/24 07:08:19 |
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Basic information
Public title
Effect Two Different Rehabilitation Approaches on Pulmonary Measures, Neuromuscular Functions and Quality of Life in Juvenile Myasthenia Gravis: A controlled randomized study
Acronym
Effect Two Different Rehabilitation Approaches on Pulmonary Measures, Neuromuscular Functions and Quality of Life in Juvenile Myasthenia Gravis: A controlled randomized study
Scientific Title
Effect Two Different Rehabilitation Approaches on Pulmonary Measures, Neuromuscular Functions and Quality of Life in Juvenile Myasthenia Gravis: A controlled randomized study
Scientific Title:Acronym
Effect Two Different Rehabilitation Approaches on Pulmonary Measures, Neuromuscular Functions and Quality of Life in Juvenile Myasthenia Gravis: A controlled randomized study
Region
| Africa |
Condition
Condition
myasthenia gravis
Classification by specialty
| Neurology | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the effectiveness partial body weight supported treadmill training on pulmonary and neuromuscular functions in children with myasthenia gravis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SPIROMETRY, Motor nerve conduction studies and repetitive nerve stimulation.
Key secondary outcomes
Six-Minute Walk Test
stability indices
MgQoL-15
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
Study group A (n=15) underwent the partial weight support for 30 min. and designed physical therapy program (balance strategy exercises and breathing exercise) for 30 min.
3 times/week for three successive months
Interventions/Control_2
control group B (n= 15) underwent the designed physical therapy program.
3 times/week for three successive 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
| 12 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- generalized mysthenia gravis
- symptoms started after 12 years of age
Key exclusion criteria
-severe cardiovascular disease
- thymectomy
- thymus hyperplasia
- respiratory diseases
- hospitalized patients
-diplopia
- inability to cope with the test and treatment procedures
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Rasha |
| Middle name | abdelmoneim |
| Last name | Mohamed |
Organization
Faculty of Physical Therapy, Cairo University, Egypt
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
dr.rashapt@gmail.com
Public contact
Name of contact person
| 1st name | Rasha |
| Middle name | abdelmoneim |
| Last name | Mohamed |
Organization
Faculty of Physical Therapy, Cairo University, Egypt
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
individualized
Institute
Department
Personal name
Funding Source
Organization
by the authors
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Physical Therapy, kafr El sheikh University, Egypt
Address
kafr El sheikh, Egypt
Tel
+20473109520
kfs_info@kfs.edu.eg.
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 | 05 | Month | 04 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35334548/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35334548/
Number of participants that the trial has enrolled
30
Results
https://pubmed.ncbi.nlm.nih.gov/35334548/
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/35334548/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/35334548/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/35334548/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/35334548/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 05 | Month | 04 | 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=R000050363
