UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019343 |
|---|---|
| Receipt number | 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 16:42:40 |
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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
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
takasaki-hiroshi@spu.ac.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022367
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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