UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059819 |
|---|---|
| Receipt number | R000068404 |
| Scientific Title | The effect of corrective exercises with theraband on the level of postural alignment, attention deficit, balance, and lower limb control in children with genu valgum on the autism spectrum |
| Date of disclosure of the study information | 2025/11/20 |
| Last modified on | 2025/11/19 02:13:18 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of corrective exercises with theraband on the level of postural alignment, attention deficit, balance, and lower limb control in children with genu valgum on the autism spectrum
Acronym
The effect of corrective exercises with theraband on the level of postural alignment, attention deficit, balance, and lower limb control in children with genu valgum on the autism spectrum
Scientific Title
The effect of corrective exercises with theraband on the level of postural alignment, attention deficit, balance, and lower limb control in children with genu valgum on the autism spectrum
Scientific Title:Acronym
The effect of corrective exercises with theraband on the level of postural alignment, attention deficit, balance, and lower limb control in children with genu valgum on the autism spectrum
Region
| Asia(except Japan) |
Condition
Condition
Pretest-Posttest
Classification by specialty
| Neurology | Pediatrics | Rehabilitation medicine |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect of corrective exercises with Theraband on valgus angle, attention deficit, balance, and lower limb function in children with autism spectrum disorder and knock knee.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Valgus angle
Key secondary outcomes
Attention deficit
Balance
Function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Treatment
Interventions/Control_2
Control
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
| 7 | years-old | <= |
Age-upper limit
| 13 | years-old | >= |
Gender
Male
Key inclusion criteria
These included autistic male child, clubbing, no history of lower limb surgery, no pathological history, spinal column, orthopedic and neurological injuries, no structural or functional shortening of more than 2 cm in one of the lower limbs, and the use of braces or other corrective orthoses such as shoe insoles during the study period.
Key exclusion criteria
The subject's unwillingness to continue participating in the exercises, absence from the exercises (2 consecutive sessions or 3 non-consecutive sessions), and failure to attend the post-test phase will be among the criteria for withdrawal from the study.
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Amir Ehsan |
| Middle name | |
| Last name | Bakhshandeh |
Organization
University of Shahid Beheshti
Division name
USB
Zip code
14911-15719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989123547613
amirehsanbakhshandeh@gmail.com
Public contact
Name of contact person
| 1st name | Amir Ehsan |
| Middle name | |
| Last name | Bakhshandeh |
Organization
shahid behshti
Division name
SBU
Zip code
14911-15719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
Homepage URL
amirehsanbakhshandeh@gmail.com
Sponsor or person
Institute
Self funding
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shahid Behshti
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
Tel
989336487376
amirehsanbakhshandeh@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
| 2025 | Year | 11 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 19 | Day |
Last modified on
| 2025 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068404
