UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053372 |
|---|---|
| Receipt number | R000060913 |
| Scientific Title | The effectiveness of vestibular-based exercise compared to virtual reality-based exercise on the balance and physical performance of children with Down Syndrome; a parallel-group randomized controlled trial |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2024/01/16 19:32:00 |
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Basic information
Public title
The effectiveness of vestibular-based exercise compared to virtual reality-based exercise on the balance and physical performance of children with Down Syndrome
Acronym
The effect of vestibular-based exercise compared to virtual reality-based exercise on children with Down Syndrome
Scientific Title
The effectiveness of vestibular-based exercise compared to virtual reality-based exercise on the balance and physical performance of children with Down Syndrome; a parallel-group randomized controlled trial
Scientific Title:Acronym
The effect of vestibular-based exercise compared to virtual reality-based exercise on children with Down Syndrome
Region
| Asia(except Japan) |
Condition
Condition
Experimental study
Classification by specialty
| Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
, the primary purpose of the current study was to investigate and compared of effectiveness of vestibular-based exercise compared to virtual reality-based exercise on the balance and physical performance of children with Down Syndrome.
Basic objectives2
Others
Basic objectives -Others
the primary purpose of the current study was to investigate and compared of effectiveness of vestibular-based exercise compared to virtual reality-based exercise on the balance and physical performance of children with DS and the second objective was to assess the effectiveness of these two interventions, if they were found to be effective.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Static and dynamic balance assessment of Down syndrome children
Key secondary outcomes
physical performance assessment of Down syndrome children
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
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Vestibular based exercise
Interventions/Control_2
Virtual reality based exercise
Interventions/Control_3
Control group
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
Key inclusion criteria
Male down syndrome children, ages of 10 and 13 years
Key exclusion criteria
Participants were excluded if they had an intelligence quotient lower than 50 or upper than 70, unable to stand and walk independently, any visible musculoskeletal deformities in the musculoskeletal system in normal standing posture [21, 22] or if they missed more than three sessions, or two consecutive sessions of the intervention program [23] taking medications that could affect muscle strength or balance, abnormal vision and hearing with or without aids, suffering from cardiovascular diseases., and suffering from neurological disorders.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Mohammadreza |
| Middle name | - |
| Last name | Seyedi |
Organization
Sport Sciences Research Institute, Tehran, Iran
Division name
Department of health and sports medicine
Zip code
0098
Address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
TEL
00982188747884
seyedi@ssrc.ac.ir
Public contact
Name of contact person
| 1st name | Mohammadreza |
| Middle name | - |
| Last name | Seyedi |
Organization
Sport Sciences Research Institute, Tehran, Iran
Division name
Department of health and sports medicine
Zip code
0098
Address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
TEL
00982188747884
Homepage URL
seyedi@ssrc.ac.ir
Sponsor or person
Institute
not applicable
Institute
Department
Personal name
Funding Source
Organization
not applicable
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
Sport Sciences Research Institute, Tehran, Iran
Address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
Tel
00982188747884
seyedi@ssrc.ac.ir
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
| 2024 | Year | 03 | Month | 30 | 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
51
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
Terminated
Date of protocol fixation
| 2022 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 11 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060913
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