UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061222 |
|---|---|
| Receipt number | R000069489 |
| Scientific Title | Effects of combined manual pressure to the posterior lower leg and active ankle movement on relative displacement between soft tissues |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/10 09:03:00 |
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Basic information
Public title
Effects of combined manual pressure to the posterior lower leg and active ankle movement on relative displacement between soft tissues
Acronym
Effects of combined manual pressure to the posterior lower leg and active ankle movement on relative displacement between soft tissues
Scientific Title
Effects of combined manual pressure to the posterior lower leg and active ankle movement on relative displacement between soft tissues
Scientific Title:Acronym
Effects of combined manual pressure to the posterior lower leg and active ankle movement on relative displacement between soft tissues
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of combined manual pressure to the posterior lower leg and active ankle movement on the relative displacement between subcutaneous tissue and the gastrocnemius muscle, and to examine its relationship with changes in ankle dorsiflexion range of motion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relative displacement between subcutaneous tissue and the gastrocnemius muscle
Key secondary outcomes
Non-weight-bearing ankle dorsiflexion range of motion
Passive ankle dorsiflexion torque
Weight-bearing ankle dorsiflexion range of motion
Subjective discomfort at maximum dorsiflexion (Visual Analog Scale)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Manual pressure
Site: Distal intermuscular region between the medial and lateral heads of the gastrocnemius muscle
Intensity: 1.2 times the pressure pain threshold
Duration: 3sets of 30 seconds
Interventions/Control_2
Active ankle movement
Range and speed: Full range of plantarflexion and dorsiflexion, performed at a pace of one cycle every 2 seconds
Duration: 3 sets of 30 seconds
Interventions/Control_3
Combined manual pressure and active ankle movement
Site: Distal intermuscular region between the medial and lateral heads of the gastrocnemius muscle
Intensity: Pressure pain threshold
Range and speed: Full range of plantarflexion and dorsiflexion, performed at a pace of one cycle every 2 seconds
Duration: 3sets of 30 seconds
Manual pressure was applied simultaneously with active ankle movement.
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
| 27 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults aged 18 years or older
Individuals who provide informed consent and are able to participate in the study
Individuals identified as right-foot dominant based on the Waterloo Footedness Questionnaire
Individuals with ankle dorsiflexion range of motion between 10 degrees and less than 30 degrees in a weight-bearing position with the knee extended
Key exclusion criteria
Individuals with a history of lower limb injury or surgery within the past year
Individuals with pain in the right lower limb
Individuals with skin abnormalities at the intervention site
Individuals with neurological or musculoskeletal disorders
Individuals who engage in regular exercise three or more times per week
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Kubo |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
hom25006@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Kubo |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Graduate School of Health and Welfare
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
Homepage URL
hpm25006@nuhw.ac.jp
Sponsor or person
Institute
Graduate School, Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Graduate School, Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
Tel
025-257-4455
rinri@nuhw.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
| 2026 | Year | 04 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2026 | Year | 08 | 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
| 2026 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069489
