UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047250 |
|---|---|
| Receipt number | R000053893 |
| Scientific Title | The effect of fatigue on the lower extremity joint angle(knee and ankle) and pain in the soles of the feet climbers before and after mountaineering |
| Date of disclosure of the study information | 2022/09/30 |
| Last modified on | 2022/03/22 16:49:44 |
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Basic information
Public title
Morteza Barzegar Befrouei
Acronym
Morteza Barzegar
Scientific Title
The effect of fatigue on the lower extremity joint angle(knee and ankle) and pain in the soles of the feet climbers before and after mountaineering
Scientific Title:Acronym
The effect of fatigue on the lower extremity joint angle(knee and ankle) and pain in the soles of the feet climbers before and after mountaineering
Region
| Asia(except Japan) |
Condition
Condition
in progress
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is hypothesized that changes in the skeletal structure of the foot may lead to changes in walking patterns and excessive loading on the bone and soft tissue structures, causing pain and injury to these areas.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
no outcome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
climbing programe
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
at least one-year mountain climbing
Key exclusion criteria
injury
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Amir Hossein |
| Middle name | |
| Last name | Barati |
Organization
Department of Sports Health and Rehabilitation, Faculty of Sports Sciences and Health, Shahid Beheshti University,
Division name
Department of Physical Education and Sport Sciences, School of Physical Education and Sport Sciences
Zip code
1983969411
Address
Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
TEL
00982129902265
ah_barati@sbu.ac.ir
Public contact
Name of contact person
| 1st name | Morteza |
| Middle name | |
| Last name | Barzegar |
Organization
Department of Sports Health and Rehabilitation, Faculty of Sports Sciences and Health, Shahid Behesh
Division name
Physical Education and Sport Sciences Faculty, Biological Sciences Department,
Zip code
1983969411
Address
Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
TEL
00982129902265
Homepage URL
M.barzegar9489@gmail.com
Sponsor or person
Institute
Department of Sports Health and Rehabilitation, Faculty of Sports Sciences and Health, Shahid Beheshti University, Tehran, Iran
Institute
Department
Personal name
Funding Source
Organization
Department of Sports Health and Rehabilitation, Faculty of Sports Sciences and Health, Shahid Beheshti University, Tehran, Iran
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 Beheshti University
Address
Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
Tel
00982129902265
M.barzegar9489@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
| 2022 | Year | 09 | 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
45
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 22 | Day |
Last modified on
| 2022 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053893
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
