UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054631 |
|---|---|
| Receipt number | R000062430 |
| Scientific Title | The effect of combining foot tape and neuromuscular electrical stimulation on flexibility compared to standard stretching: a randomized crossover study using a non-inferiority/equivalence design |
| Date of disclosure of the study information | 2024/06/11 |
| Last modified on | 2025/06/11 12:54:31 |
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Basic information
Public title
The effect of combining foot tape and neuromuscular electrical stimulation on flexibility compared to standard stretching: a randomized crossover study using a non-inferiority/equivalence design
Acronym
The effect of combining foot tape and neuromuscular electrical stimulation on flexibility compared to standard stretching: a randomized crossover study using a non-inferiority/equivalence design
Scientific Title
The effect of combining foot tape and neuromuscular electrical stimulation on flexibility compared to standard stretching: a randomized crossover study using a non-inferiority/equivalence design
Scientific Title:Acronym
The effect of combining foot tape and neuromuscular electrical stimulation on flexibility compared to standard stretching: a randomized crossover study using a non-inferiority/equivalence design
Region
| Japan |
Condition
Condition
Healthy university students
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary endpoints will be ankle dorsiflexion angle (DFA) as an index of flexibility in terms of ankle dorsiflexion range of motion, and straight leg raising (SLR) and finger-floor distance (FFD) as indexes of flexibility in terms of hamstrings. To evaluate the non-inferiority and equivalence of the combined effects of foot tape and neuromuscular electrical stimulation on stretching.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DFA, SLR, and FFD after intervention
Key secondary outcomes
Post-intervention ankle plantar flexion strength (PFS) and knee flexion strength (KFS)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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 combined neuromuscular electrical stimulation and foot tape group received kinesiology tape (NK-50, Nitto Denko, Japan) cut to 50% of the foot length and attached to the sole of their dominant foot, followed by 5 minutes of electrical stimulation of the posterior muscles of the lower leg. The electrical stimulation settings were pulse width 250 microsecond, frequency 80 Hz, and stimulation and rest periods of 3 seconds each for 1 minute.
Interventions/Control_2
Participants assigned to the stretch group spent 5 minutes on a tilt table that was set up to stretch the posterior leg muscles.
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
| 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
83
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
others
Institute
Department
Personal name
Funding Source
Organization
others
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
324-8501
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
83
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
| 2024 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 10 | 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
| 2024 | Year | 06 | Month | 11 | Day |
Last modified on
| 2025 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062430
