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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044102
Receipt No. R000050363
Scientific Title Effect of partial body weight supported treadmill training on pulmonary and neuromuscular functions in children with myasthenia gravis
Date of disclosure of the study information 2021/05/04
Last modified on 2021/06/03

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Basic information
Public title Effect of partial body weight supported treadmill training on pulmonary and neuromuscular functions in children with myasthenia gravis
Acronym Effect of partial body weight supported treadmill training on pulmonary and neuromuscular functions in children with myasthenia gravis
Scientific Title Effect of partial body weight supported treadmill training on pulmonary and neuromuscular functions in children with myasthenia gravis
Scientific Title:Acronym Effect of partial body weight supported treadmill training on pulmonary and neuromuscular functions in children with myasthenia gravis
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
Email 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
Email dr.rashapt@gmail.com

Sponsor
Institute individualized
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 30
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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 13 Day
Anticipated trial start date
2021 Year 03 Month 05 Day
Last follow-up date
2021 Year 06 Month 05 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
2021 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050363

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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