UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042363 |
|---|---|
| Receipt number | R000048360 |
| Scientific Title | Impact of Schroth Three-Dimensional versus Proprioceptive Neuromuscular Facilitation Techniques in Adolescent Idiopathic Scoliosis: A Rondomized Controlled Study |
| Date of disclosure of the study information | 2020/11/06 |
| Last modified on | 2023/11/24 07:10:21 |
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Basic information
Public title
Impact of Schroth Three-Dimensional versus Proprioceptive Neuromuscular Facilitation Techniques in Adolescent Idiopathic Scoliosis: A Rondomized Controlled Study
Acronym
Impact of Schroth Three-Dimensional versus Proprioceptive Neuromuscular Facilitation Techniques in Adolescent Idiopathic Scoliosis: A Rondomized Controlled Study
Scientific Title
Impact of Schroth Three-Dimensional versus Proprioceptive Neuromuscular Facilitation Techniques in Adolescent Idiopathic Scoliosis: A Rondomized Controlled Study
Scientific Title:Acronym
Impact of Schroth Three-Dimensional versus Proprioceptive Neuromuscular Facilitation Techniques in Adolescent Idiopathic Scoliosis: A Rondomized Controlled Study
Region
| Asia(except Japan) |
Condition
Condition
rehabilitation medicine
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of PNF on scoliosis angle, static plantar pressure distribution and functional capacity in AIS. Further aimed to compare the effectiveness of Schroth 3D technique to that of the PNF on scoliosis angle, static plantar pressure distribution and functional capacity.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase IV
Assessment
Primary outcomes
Cobb angle
before and after six successive months of treatment.
Key secondary outcomes
angle trunk rotation
static plantar pressure distribution
functional capacity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The Schroth group underwent Schroth 3D technique. The patients received treatment for one hour/ three times per week for six successive months.
Interventions/Control_2
The PNF group received the PNF technique. The patients received treatment for one hour/ three times per week for six successive months. The program included 6 patterns and each pattern was trained for 10 min.
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
| 14 | years-old | <= |
Age-upper limit
| 16 | years-old | >= |
Gender
Female
Key inclusion criteria
The angle of scoliosis was less than 25 degrees, a Risser sign of 2 or 4, and, not participated in other treatment.
Key exclusion criteria
previous spinal surgery, cardiac anomalies, obesity, asthma or other pulmonary disease, mental problems, neuromuscular or rheumatic diseases, kyphoscoliosis.
Target sample size
34
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
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
TEL
00966508771352
Homepage URL
dr.rashapt@gmail.com
Sponsor or person
Institute
Al-Qassim University Saudi Arabia
department of physical therapy
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
El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki - Giza, Giza District, 11432, Egypt
Tel
+20 237617691
dr.elsayedhassanpt@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
Outpatient Clinic of Al-Qassim University, Saudi Arabia.
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34982433/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34982433/
Number of participants that the trial has enrolled
34
Results
https://pubmed.ncbi.nlm.nih.gov/34982433/
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/34982433/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/34982433/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/34982433/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/34982433/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 11 | 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
| 2020 | Year | 11 | Month | 06 | 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=R000048360
