UMIN-CTR Clinical Trial

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
Email	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
Email	igatatsu.7@gmail.com

Sponsor
Institute	International University of health and welfare
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050873