UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045470 |
|---|---|
| Receipt number | R000051874 |
| Scientific Title | Physical, mental and Quality of life changes before and after using a sports prosthesis |
| Date of disclosure of the study information | 2021/09/13 |
| Last modified on | 2023/09/20 14:15:21 |
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Basic information
Public title
Physical, mental and Quality of life changes before and after using a sports prosthesis
Acronym
Physical, mental and Quality of life changes before and after using a sports prosthesis
Scientific Title
Physical, mental and Quality of life changes before and after using a sports prosthesis
Scientific Title:Acronym
Physical, mental and Quality of life changes before and after using a sports prosthesis
Region
| Japan |
Condition
Condition
lower amputation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We research the changes of athletic ability, mentality and
quality of life by using a sprinting prosthesis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measure 4 parts of athletic abilities.
Items are 1.instantaneous power 2.endurance 3.respiratory function and4.gait. Measurement is carried out fourtimes in total, starting,one month, six months, and one year.
Key secondary outcomes
Mentality and Quality of life are measured by using PEQJ(Prosthestics Evaluating Questionnaire Japan)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We order prosthesis for sprinting to every examinees and we teach them the methods of running once a month.And also we check the notes which examinees can write the details about their sports everytimes.
The terms of research is one year.
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
| 7 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We select lower amputees who have never run with using a prosthesis for sprinting and who understand the aims of our research.
Key exclusion criteria
We exclude the lower amputees if they have special reasons. We explain special reasons as follow.
1. the lower amputees who has to limit exercises by specified diseases.
2.the lower amputees who cannot understand the meanings, objectives and methods about our research.
3.the lower amputees we judge some difficulties about attending our reseach.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Hamada |
Organization
Jikei University Katsushika Medical Center
Division name
Department of Rehabiltation Medicine
Zip code
1258506
Address
6-41-2 Aoto,Katsushika-ku,Tokyo 125-8506,JAPAN
TEL
0336032111
mayuhama@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Hamada |
Organization
Jikei University Katsushika Medical Center
Division name
Department of Rehabiltation Medicine
Zip code
1258506
Address
6-41-2 Aoto,Katsushika-ku,Tokyo 125-8506,JAPAN
TEL
0336032111
Homepage URL
mimari1002@outlook.jp
Sponsor or person
Institute
Jikei University Katsushika Medical Center
Department of Rehabiltation Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan General Insurance Association
Damage Service Planning Department Medical Research
Center
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei University Ethics Committee
Address
3-19-8 Nishishinnbashi,Minato-ku,Tokyo 105-8471,JAPAN
Tel
0334331111
rinri@jikei.ac.jp
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
| 2021 | Year | 09 | Month | 13 | 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
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051874
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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