UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044525 |
|---|---|
| Receipt number | R000050873 |
| Scientific Title | Differences in flexibility improvement between Foot tape and standard stretching : A randomized controlled trial with a non-inferiority/equivalence trial design |
| Date of disclosure of the study information | 2021/06/20 |
| Last modified on | 2021/11/12 16:43:10 |
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Basic information
Public title
Differences in flexibility improvement between Foot tape and standard stretching : A randomized controlled trial with a non-inferiority/equivalence trial design
Acronym
Differences in flexibility improvement between Foot tape and standard stretching : A randomized controlled trial with a non-inferiority/equivalence trial design
Scientific Title
Differences in flexibility improvement between Foot tape and standard stretching : A randomized controlled trial with a non-inferiority/equivalence trial design
Scientific Title:Acronym
Differences in flexibility improvement between Foot tape and standard stretching : A randomized controlled trial with a non-inferiority/equivalence trial design
Region
| Japan |
Condition
Condition
Healthy university students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the non-inferiority and equivalence of foot tape's flrxibility-enhancing effect on static stretching by setting the primary outcomes with straight-leg-raising (SLR) and floor-finger-distance (FFD) as indicators of hamstrings flexibility.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SLR angle and FFD after intervention
Key secondary outcomes
Post-intervention hip flexor strength (HFS), knee extension strength (KES), two step distance (TSD), and pain intensity during the intervention using the numeric rating scale (NRS).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and 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 assigned to the Stretching group will be subjected to static stretching of the hamstrings. One researcher whose participant allocation is concealed will individually teach how to stretch. The frequency of treatment is to hold for 30 seconds only once.
Interventions/Control_2
kinesiology tape (NK-50, NITTO DENKO, Japan) is attached to the sole of feet of the participants assigned to the foot tape group. The tape will be applied by the same investigator who will be blinded to the participant's assignment.
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Physically active university students
Key exclusion criteria
Exclusion criteria shall be as follows
(1) Lower extremity injury in the past 6 weeks
(2) Lumbar spine lesions in the past 6 weeks (e.g., known lumbar lesions that limit ROM, previous lumbar spine surgery, lumbar spine lesions including known lumbosacral spine physical impairment that limits ROM and function)
(3) Lower extremity surgery within the past 6 months or major ligamentous surgery within the past year
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Igawa |
Organization
International University of health and welfare
Division name
Faculty of Health Sciences, Department of Physical Therapy
Zip code
324-8501
Address
2600-1 Kitakanemaru,Otawara Tochigi
TEL
0287-24-3082
igatatsu.7@gmail.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Igawa |
Organization
International University of health and welfare
Division name
Faculty of Health Sciences, Department of Physical Therapy
Zip code
324-8501
Address
2600-1 Kitakanemaru,Otawara Tochigi
TEL
0287-24-3082
Homepage URL
igatatsu.7@gmail.com
Sponsor or person
Institute
International University of health and welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of health and welfare
Address
2600-1 Kitakanemaru,Otawara Tochigi
Tel
0287-24-3082
igatatsu.7@gmail.com
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
国際医療福祉大学（栃木都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 20 | 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
64
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
| 2021 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 10 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 14 | Day |
Last modified on
| 2021 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050873
| 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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