UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044103 |
|---|---|
| Receipt number | 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 | 2023/11/24 07:27:12 |
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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
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
College of medical rehabilitation, Qassim University, Saudi Arabia.
Institute
Department
Personal name
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
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
https://revistas.um.es/sportk/article/view/528801
Publication of results
Unpublished
Result
URL related to results and publications
https://revistas.um.es/sportk/article/view/528801
Number of participants that the trial has enrolled
60
Results
https://revistas.um.es/sportk/article/view/528801
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://revistas.um.es/sportk/article/view/528801
Participant flow
https://revistas.um.es/sportk/article/view/528801
Adverse events
https://revistas.um.es/sportk/article/view/528801
Outcome measures
https://revistas.um.es/sportk/article/view/528801
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
| 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=R000050365
