UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055749 |
|---|---|
| Receipt number | R000063710 |
| Scientific Title | Correlation between foot posture index with coronal balance of spine in individuals with mild adolescent idiopathic scoliosis |
| Date of disclosure of the study information | 2026/03/12 |
| Last modified on | 2024/10/05 00:35:42 |
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Basic information
Public title
Study on the correlation between foot posture index with pelvic obliquity and coronal balance of spine in individuals with mild adolescent idiopathic scoliosis
Acronym
AIS(Adolescent idiopathic scoliosis) CB( coronal balance) FPI( foot posture index)
Scientific Title
Correlation between foot posture index with coronal balance of spine in individuals with mild adolescent idiopathic scoliosis
Scientific Title:Acronym
Correlation between FPI with CB of spine in individuals with mild AIS: a pliot study
Region
| Japan | Asia(except Japan) |
Condition
Condition
Adolescent idiopathic scoliosis
Classification by specialty
| Orthopedics | Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
80 untreated patients with mild adolescent idiopathic scoliosis including 40 subjects with thoracic carvature and 40 partupants with lumbar curvature.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Foot Postural Index
The deviation value of the apical vertebra
The deviation value of the 7th cervical vertebra
Pelvic Obliquity angle on the coronal plane
Cobb angle
Key secondary outcomes
Apical vertebral rotation angle
Plantar pressure of seven zones of each foot
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Forty patients with single thoracic curvature and 40 patients with single lumbar curvature of mild AIS patients will be recruited, and 20 participants with single thoracic curvature (as group A) and 20 participants with lumbar curvature (as group B) were randomly selected as the experimental group, while the remaining 20 participants with single thoracic curvature (as group A') and 20 participants with lumbar curvature (as group B') served as the corresponding control group.
Interventions/Control_2
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
| 16 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
AIS patients with a single thoracic curve or a single lumbar curve between the ages of 10 and 16 years old without treatment and with a Cobb angle greater than 10 degree and less than 20 degree.The subjects understand the experimental content, voluntarily participate in the experiment, and can cooperate to complete the entire experimental process.
Key exclusion criteria
Leg length discrepancy greater than 1cm,Any movement impairment,low back pain, neurologic abnormalities observed on clinical examination,or any previous treatment for scoliosis .Double principal curves or triple principal curves,Cobb angle small than 10 degree or Cobb angle greater than 20 degree, Age does not meet.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Jiangang |
| Middle name | |
| Last name | Cao |
Organization
International University of Health and Welfare
Division name
Assistive Technological Science
Zip code
107-8402
Address
4-1-26 Akasaka, Minato
TEL
080-8761-0933
18952172846@163.com
Public contact
Name of contact person
| 1st name | Jiangang |
| Middle name | |
| Last name | Cao |
Organization
International University of Health and Welfare
Division name
Assistive Technological Science
Zip code
107-8402
Address
4-1-26 Akasaka, Minato
TEL
080-8761-0933
Homepage URL
18952172846@163.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Graduate instruction fee of International University of Health and Welfare
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
4-1-26 Akasaka, Minato
Tel
080-8761-0933
18952172846@163.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
International University of Health and Welfare
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 12 | 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
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 05 | Day |
Last modified on
| 2024 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063710
