UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052005 |
|---|---|
| Receipt number | R000059362 |
| Scientific Title | Effects of ankle joint stretching and toe flexion exercise with stretch socks on ankle joint range of motion, toe strength, and balance |
| Date of disclosure of the study information | 2023/08/26 |
| Last modified on | 2024/08/27 09:01:08 |
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Basic information
Public title
Effects of ankle joint stretching and toe flexion exercise with stretch socks on ankle joint range of motion, toe strength, and balance
Acronym
Effects of ankle joint stretching and toe flexion exercise with stretch socks on ankle joint range of motion, toe strength, and balance
Scientific Title
Effects of ankle joint stretching and toe flexion exercise with stretch socks on ankle joint range of motion, toe strength, and balance
Scientific Title:Acronym
Effects of ankle joint stretching and toe flexion exercise with stretch socks on ankle joint range of motion, toe strength, and balance
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of ankle joint stretching and toe flexion exercises using Stretch Socks on ankle joint range of motion, toe muscle strength, and balance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle range of motion, passive torque, muscle displacement, EMG, center of pressure,
toe flexor strength
Key secondary outcomes
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Stretching for 30 sec
Interventions/Control_2
Stretching for 60 sec
Interventions/Control_3
Stretching for 120 sec
Interventions/Control_4
rest
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women between the ages of 18 and 30
Key exclusion criteria
Those with orthopedic conditions of the lower extremities
Those who habitually perform strength training or stretching
Those who have a conflict of interest with the principal investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Mizuno |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
0527893959
mizuno@htc.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Mizuno |
Organization
Nagoya University
Division name
Research Center of Health, Physical Fitness and Sports
Zip code
464-8601
Address
Furo-cho, Chikusa-ku, Nagoya
TEL
0527893959
Homepage URL
mizuno@htc.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
YOKOYAMA SEIMITSU Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Center of Health, Physical Fitness and Sports
Address
Furo-cho, Chikusa-ku, Nagoya
Tel
0527893959
mizuno@htc.nagoya-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
| 2023 | Year | 08 | 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
22
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 03 | 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
| 2023 | Year | 08 | Month | 25 | Day |
Last modified on
| 2024 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059362
