UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057964 |
|---|---|
| Receipt number | R000066260 |
| Scientific Title | Effects of combined manual pressure applied to the gastrocnemius and active ankle movement on ankle dorsiflexion range of motion |
| Date of disclosure of the study information | 2025/05/26 |
| Last modified on | 2026/02/24 10:15:29 |
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Basic information
Public title
Effects of combined manual pressure applied to the gastrocnemius and active ankle movement on ankle dorsiflexion range of motion
Acronym
Effects of combined manual pressure applied to the gastrocnemius and active ankle movement on ankle dorsiflexion range of motion
Scientific Title
Effects of combined manual pressure applied to the gastrocnemius and active ankle movement on ankle dorsiflexion range of motion
Scientific Title:Acronym
Effects of combined manual pressure applied to the gastrocnemius and active ankle movement on ankle dorsiflexion range of motion
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of combined manual pressure applied to the gastrocnemius and active ankle movement on ankle dorsiflexion range of motion, and to examine the underlying factors associated with these effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle dorsiflexion range of motion
Key secondary outcomes
Ankle passive torque
Shear wave elastography of the gastrocnemius muscle
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
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: pressure pain threshold
Duration: 3 sets of 30 seconds
Interventions/Control_2
Manual pressure combined with active ankle movement
Site: distal intermuscular region between the medial and lateral heads of the gastrocnemius muscle
Intensity: pressure pain threshold
Duration: 3 sets of 30 seconds
Active ankle movement: active plantarflexion and dorsiflexion of the ankle were performed simultaneously with manual pressure. One cycle consisted of movement from 30 degrees of plantarflexion to 10 degrees of dorsiflexion and back, completed within 2 seconds.
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
| 27 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Undergraduate and graduate students enrolled at Niigata University of Health and Welfare were eligible for inclusion if they expressed interest in this study, voluntarily agreed to participate, and were identified as right-foot dominant according to the Waterloo Footedness Questionnaire.
Key exclusion criteria
Participants were excluded if they had a history of lower limb injury or surgery within the past year, exhibited skin abnormalities at the intervention site, or had neurological or musculoskeletal disorders.
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
| 2025 | Year | 05 | Month | 26 | 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
20
Results
Ankle dorsiflexion range of motion increased after the intervention combining manual pressure with active ankle movement.
Results date posted
| 2026 | Year | 02 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 20 participants were analyzed, all of whom were healthy undergraduate or graduate students with right foot dominance.
Participant flow
22 participants were recruited, two were excluded, and the remaining 20 participants completed the study with no dropouts.
Adverse events
No adverse events were observed during the study.
Outcome measures
The primary outcome measure was ankle dorsiflexion range of motion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2025 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Some of the intervention conditions and outcome measures originally planned could not be implemented due to practical constraints during the conduct of the study. Therefore, the study was carried out using only the feasible conditions and measurements.
Management information
Registered date
| 2025 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066260
