UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057181 |
|---|---|
| Receipt number | R000065363 |
| Scientific Title | Real and Sham Transcranial direct-current stimulation (tDCS) plus core stability on the knee kinematic and performance of the lower limb of the soccer players with dynamic knee valgus; two armed randomized clinical trial |
| Date of disclosure of the study information | 2025/05/28 |
| Last modified on | 2025/03/01 02:07:52 |
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Basic information
Public title
Real and Sham Transcranial direct-current stimulation (tDCS) plus core stability on the knee kinematic and performance of the lower limb of the soccer players with dynamic knee valgus; two armed randomized clinical trial
Acronym
Real and Sham Transcranial direct-current stimulation (tDCS) plus core stability on the knee kinematic and performance of the lower limb of the soccer players with dynamic knee valgus; two armed randomized clinical trial
Scientific Title
Real and Sham Transcranial direct-current stimulation (tDCS) plus core stability on the knee kinematic and performance of the lower limb of the soccer players with dynamic knee valgus; two armed randomized clinical trial
Scientific Title:Acronym
Real and Sham Transcranial direct-current stimulation (tDCS) plus core stability on the knee kinematic and performance of the lower limb of the soccer players with dynamic knee valgus; two armed randomized clinical trial
Region
| Asia(except Japan) |
Condition
Condition
Pre- Post
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focuses on knee kinematics and the performance of male young soccer players with DKV
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematic
Key secondary outcomes
Performance
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
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Players in group 1 performed an tDCS along with core stability exercises for 8 weeks
Interventions/Control_2
Group 2 or sham only worked with the device turned off
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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
Male gender
Age range 18 to 25 years
Having at least three years of experience in soccer
having a normal body mass index (20 to 23)
Existence of dynamic valgus during single leg landing test
Absence of obvious abnormalities of the lower limbs (femoral anteversion, Genu valgum, Genu varum, tibial rotation and flat soles)
No history of surgery in the trunk and lower limbs
No history of permanent injury such as degenerative changes in the knee joint, chronic instability of the ankle, etc.
Absence of anterior cruciate ligament injury
Absence of lower limb injury in the past year
Failure to attend the anterior cruciate ligament injury prevention program
Key exclusion criteria
Absence in two consecutive sessions or three training sessions from the entire training program
Reluctance to continue participating in exercises, Causing injury and pain during the training period or in sports activity
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Hadi |
| Middle name | |
| Last name | Mohammadi Nia Samakosh |
Organization
Kharazmi university
Division name
Khu
Zip code
14911-15719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
shahramsamakosh92@yahoo
Public contact
Name of contact person
| 1st name | Hadi |
| Middle name | |
| Last name | Mohammadi Nia Samakosh |
Organization
Kharazmi university
Division name
Khu
Zip code
14911-15719
Address
Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL
989336487376
Homepage URL
https://www.linkedin.com/in/hadi-shahram-mohammadi-nia-samakosh-308091194
shahramsamakosh92@yahoo
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
Ethics Committee of the Polytechnic Institute of Santarem, Portugal (29-2022ESDRM).
Address
Portugal
Tel
23227250
rafaeloliveira@esdrm.ipsantarem.pt
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 | 05 | Month | 28 | 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 | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2025 | Year | 03 | Month | 01 | Day |
Last modified on
| 2025 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065363
