UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059641 |
|---|---|
| Receipt number | R000067420 |
| Scientific Title | Effects of Dynamic HTS Stretching on Hamstring Flexibility: A Clinical Study |
| Date of disclosure of the study information | 2025/11/05 |
| Last modified on | 2025/11/05 12:22:38 |
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Basic information
Public title
Effectiveness of Dynamic Hamstring Stretching Using a Hybrid Training System (HTS)
Acronym
HTS-DHS Trial
Scientific Title
Effects of Dynamic HTS Stretching on Hamstring Flexibility: A Clinical Study
Scientific Title:Acronym
HTS-HF Trial
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Flexibility through Dynamic Stretching with an Electrical Stimulation Device
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Electrical stimulation will be applied to one leg, while the other leg will serve as the control and undergo dynamic stretching. Flexibility will be evaluated before and after the intervention as an immediate effect, using the sit-and-reach test, the Passive Straight Leg Raising (PSLR) test, and the Active Knee Extension (AKE) test.
After a one-week interval, electrical stimulation will be applied to the opposite leg, and the same intervention will be conducted.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Electrical stimulation devices will be attached to both thighs, but stimulation will be applied only to one leg, while the other leg will serve as the control without stimulation. Dynamic stretching will then be performed under these conditions.
After a one-week washout period, electrical stimulation will be applied to the opposite leg, and dynamic stretching will again be performed.
Flexibility will be assessed before and after stretching in each condition.
Interventions/Control_2
Electrical stimulation devices will be attached to both thighs, but stimulation will be applied only to one leg, while the other leg will serve as the control without stimulation. Dynamic stretching will then be performed under these conditions.
After a one-week washout period, electrical stimulation will be applied to the opposite leg, and dynamic stretching will again be performed.
Flexibility will be assessed before and after stretching in each condition.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants eligible for this study will be those who meet all of the following criteria: individuals who are healthy, have no current acute illness requiring treatment and are able to perform exercise, are between 18 and 65 years of age at the time of obtaining consent, and have provided written informed consent to participate in the study.
Key exclusion criteria
Participants who meet any of the following conditions will be excluded from this study: those diagnosed with coronary artery disease or neuromuscular disorders; those currently receiving anticoagulant, antiplatelet, or other medications affecting bleeding tendency; those under treatment for malignant diseases, including metastatic bone tumors; those with dementia that interferes with activities of daily living (other than grade 1-2 on the Dementia Scale for Independence in Daily Living of the Elderly with Dementia) and those who will exceed 65 years of age by the completion of study participation.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Matsuse |
Organization
Rehabilitation Center, Kurume University
Division name
Rehabilitation Center
Zip code
830-0011
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-35-3311
kurumerehahpdoctor@gmail.com
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Maki |
Organization
Kurume Univercity
Division name
Department of Orthopaedic Surgery, Rehabilitation Unit
Zip code
830-0011
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
TEL
0942-31-7645
Homepage URL
maki_yuuji@kurume-u.ac.jp
Sponsor or person
Institute
Kurume Univercity
Institute
Department
Personal name
Hiroo Matsuse
Funding Source
Organization
self-sourcing
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
Kurume University Medical Ethics Committee
Address
67 Asahi-machi, Kurume-shi, Fukuoka, Japan
Tel
0942-65-3749
i_rinri@kurume-u.ac.jp
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
| 2025 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067420
