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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029010
Receipt No. 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

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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
Email 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
Email h-fujishita@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033090

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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