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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019343
Receipt No. R000022367
Scientific Title Establishing evaluation for relative flexibility of hamstrings and investigating impacts of stretching ways on hamstrings flexibility
Date of disclosure of the study information 2015/10/14
Last modified on 2017/02/01

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Basic information
Public title Establishing evaluation for relative flexibility of hamstrings and investigating impacts of stretching ways on hamstrings flexibility
Acronym Comparing effectiveness of interventions using jack-knife hamstring stretching and stretching with maintenance of lumbar lordosis for those with reduction of relative flexibility of hamstring to the back: a randomized control trial
Scientific Title Establishing evaluation for relative flexibility of hamstrings and investigating impacts of stretching ways on hamstrings flexibility
Scientific Title:Acronym Comparing effectiveness of interventions using jack-knife hamstring stretching and stretching with maintenance of lumbar lordosis for those with reduction of relative flexibility of hamstring to the back: a randomized control trial
Region
Japan

Condition
Condition Healthy individuals or those with low back pain
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study will be to investigate if hamstring stretching with maintenance of lumbar lordosis increases relative flexibility of hamstring to the back better than jack-knife hamstring stretching for those with reduction of relative flexibility of hamstring to the back.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relative flexibility of hamstring to the back will be assessed with the degree of lumbar lordosis when a knee is fully extended in sitting. The prevalence of low back pain will be assessed with a self-reporting questionnaire. Evaluation will be performed at the time of participant's inclusion and 5 weeks after the intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Participants in the jack-knife hamstring stretching group will do jack-knife hamstring stretching for 5 weeks (15 seconds x 4 repetitions/set x 3 sets/day) at home.
Interventions/Control_2 Participants in the hamstring stretching with maintenance of lumbar lordosis group will do hamstring stretching by active right knee extension while maintenance of lumbar lordosis for 5 weeks (15 seconds x 4 repetitions/set x 3 sets/day) at home.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria Those who will lose lumbar lordosis when extending the knee (10 degrees of knee flexion)
Key exclusion criteria Those with symptoms over the lower limb
Those with reduction of knee extension range from 10 degrees of knee flexion in sitting when ankle dorsal flexion is added
Target sample size 54

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Takasaki
Organization Saitama Prefectural University
Division name Physical Therapy
Zip code
Address Sannomiya 820, Koshigaya, Saitama
TEL 0489734706
Email takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Takasaki
Organization Saitama Prefectural University
Division name Physical Therapy
Zip code
Address Sannomiya 820, Koshigaya, Saitama
TEL 0489734706
Homepage URL
Email takasaki-hiroshi@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

Funding Source
Organization None
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
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
2015 Year 10 Month 14 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
2015 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 10 Month 14 Day
Last modified on
2017 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022367

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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