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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044103
Receipt No. R000050365
Scientific Title Effect of pressure biofeedback training on lumbar hyperlordosis, respiratory muscle strength and balance in spastic diaplegic children
Date of disclosure of the study information 2021/05/04
Last modified on 2021/05/10

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Basic information
Public title Effect of pressure biofeedback training on lumbar hyperlordosis, respiratory muscle strength and balance in spastic diaplegic children
Acronym Effect of pressure biofeedback training on lumbar hyperlordosis, respiratory muscle strength and balance in spastic diaplegic children
Scientific Title Effect of pressure biofeedback training on lumbar hyperlordosis, respiratory muscle strength and balance in spastic diaplegic children
Scientific Title:Acronym Effect of pressure biofeedback training on lumbar hyperlordosis, respiratory muscle strength and balance in spastic diaplegic children
Region
Asia(except Japan)

Condition
Condition diplegic cerebral palsy
Classification by specialty
Rehabilitation medicine Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness of pressure biofeedback training of abdominal, hip extensor muscles on lumbar lordotic angle, lumbar range of motion, hip range of motion and balance in spastic diaplegic children.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes lumbar lordotic angle
Key secondary outcomes lumbar ROM, hip ROM and balance

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
Maneuver
Interventions/Control_1 abdominal & hip extensor muscles pressure biofeedback training for 30 min/ 3 times/ week for three successive months
a specialized physical therapy program for 1 h / 3 times per week for three successive months.
Interventions/Control_2 a specialized physical therapy program for 1 h / 3 times per 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
10 years-old <=
Age-upper limit
13 years-old >=
Gender Male and Female
Key inclusion criteria They had sufficient cognition and were able to understand commands given to them, level II on Gross Motor Function Classification Scale (GMFCS). The degree of spasticity was grade 1+ and 2 based on Modified Ashowrth Scale. They were able to walk without assistance.
Key exclusion criteria genetic or metabolic problems, previous surgery of the LLS, Botox injection of the LLS within the preceding 6 months, contractures of the LLS, vision problems, epilepsy, blood diseases and congenital heart disease,.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Rasha
Middle name abdelmoneim
Last name Mohamed
Organization 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 College of medical rehabilitation, Qassim University, Saudi Arabia.
Institute
Department

Funding Source
Organization non
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, Cairo University, Egypt
Address Burrydah, Al Qassim, Kingdom of Saudi Arabia
Tel 00201284680606
Email maya.sameh.menese@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 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 60
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 02 Month 01 Day
Date of IRB
2021 Year 02 Month 04 Day
Anticipated trial start date
2021 Year 02 Month 06 Day
Last follow-up date
2021 Year 05 Month 06 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 05 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050365

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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