UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029010 |
|---|---|
| Receipt number | R000033090 |
| Scientific Title | evaluation of muscle contraction property in lower limb amputee athlete and development of effective recovery method from muscle fatigues |
| Date of disclosure of the study information | 2017/09/09 |
| Last modified on | 2019/10/15 22:47:12 |
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Basic information
Public title
evaluation of muscle contraction property in lower limb amputee athlete and development of effective recovery method from muscle fatigues
Acronym
evaluation of muscle contraction property in lower limb amputee athlete and development of effective recovery method from muscle fatigues
Scientific Title
evaluation of muscle contraction property in lower limb amputee athlete and development of effective recovery method from muscle fatigues
Scientific Title:Acronym
evaluation of muscle contraction property in lower limb amputee athlete and development of effective recovery method from muscle fatigues
Region
| Japan |
Condition
Condition
lower limb amputation
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an effective recovery method to clarify the lower limb muscle contraction properties of the lower limb amputated athlete and the change in the recovery process after muscle fatigue and promote muscle fatigue recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle contraction properties
muscle hardness
muscle oxygen saturatuin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Healthy group (control)
Sprint and Jump Performance Test
20m Sprint: 1 time
Single leg Continuous counter movement jump : 1 time
Recovery intervention 1
Static stretching: 10 minutes
Recovery intervention 2
Icing for 20 minutes
Recovery intervention 3
Standing on whole-body vibration stimulating device: 10 minutes
Recovery intervention 4
Jogging at study subject's comfortable speed: 10 minutes
Interventions/Control_2
Lower limb amputation group (Amputee soccer player)
Sprint and Jump Performance Test
20m Sprint: 1 time
Single leg Continuous counter movement jump : 1 time
Recovery intervention 1
Static stretching: 10 minutes
Recovery intervention 2
Icing for 20 minutes
Recovery intervention 3
Standing on whole-body vibration stimulating device: 10 minutes
Recovery intervention 4
Jogging at study subject's comfortable speed: 10 minutes
Interventions/Control_3
Lower limb amputation group (Athletics)
Sprint and Jump Performance Test
20m Sprint: 1 time
Single leg Continuous counter movement jump : 1 time
Recovery intervention 1
Static stretching: 10 minutes
Recovery intervention 2
Icing for 20 minutes
Recovery intervention 3
Standing on whole-body vibration stimulating device: 10 minutes
Recovery intervention 4
Jogging at study subject's comfortable speed: 10 minutes
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
| 50 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy subject group
Be aged 20 to 50 years old when acquiring
Person who obtains consent in writing on participation of this research
Lower limb amputee group
Be aged 20 to 50 years old when acquiring
Person who obtains consent in writing on participation of this research
Players who have experienced amateur soccer for over 2 years
Short-distance sprint players who are wearing prosthetic legs and have at least 2 years of track and field sports and domestic or international classfication
Key exclusion criteria
Healthy person
Persons who have orthopedic diseases in the lower limbs
Others who are deemed inappropriate for the researcher to conduct this research
Lower leg amputee
There is an operation history or orthopedic disease on the non-cutting side
When there is abnormality such as reddening on the cut edge of the cutting side lower limb
I quit the competition during the measurement period
Others who are deemed inappropriate for the research staff to conduct this research
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Urabe Yukio |
Organization
Hiroshima University
Division name
Depertment of Sports Rehabilitation
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
082-257-5405
yurabe@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujishita Hironori |
Organization
Hiroshima University
Division name
Depertment of Sports Rehabilitation
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima, Japan
TEL
082-257-6334
Homepage URL
h-fujishita@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 09 | Month | 09 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2019 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033090
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| Registered date | File name |
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