UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042105 |
|---|---|
| Receipt number | R000047933 |
| Scientific Title | Investigation of stiffness change and effect of stretching for Achilles tendon using ultrasound imaging in patients after trauma and surgery: a pilot study |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2021/06/03 13:41:05 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of stiffness change and effect of stretching for Achilles tendon using ultrasound imaging in patients after trauma and surgery: a pilot study
Acronym
Investigation of stiffness change and effect of stretching for Achilles tendon using ultrasound imaging in patients after trauma and surgery: a pilot study
Scientific Title
Investigation of stiffness change and effect of stretching for Achilles tendon using ultrasound imaging in patients after trauma and surgery: a pilot study
Scientific Title:Acronym
Investigation of stiffness change and effect of stretching for Achilles tendon using ultrasound imaging in patients after trauma and surgery: a pilot study
Region
| Japan |
Condition
Condition
fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate stiffness change and effect of stretching for Achilles tendon in patients after trauma and surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Achilles tendon stiffness
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Stretching using muscle contraction for 6 weeks
Interventions/Control_2
Static stretching for 6 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with at least one or more fractures of the tibia, fibula, and calcaneus
Key exclusion criteria
1.Patients with contralateral tendon stiffness changes and ankle dorsiflexion range of motion limitation due to past medical history
2.Patients who cannot conform exercise instruction due to dementia
3.Patients judged by the principal investigator to be inappropriate
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Fukumoto |
Organization
Nozaki Tokushukai Hospital
Division name
rehabilitation
Zip code
574-0011
Address
2-10-50, Tanigawa, Daitou-shi, Osaka, Japan
TEL
072-874-1640
nozaki_fukumoto@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Fukumoto |
Organization
Nozaki Tokushukai Hospital
Division name
rehabilitation
Zip code
574-0011
Address
2-10-50, Tanigawa, Daitou-shi, Osaka, Japan
TEL
072-874-1640
Homepage URL
nozaki_fukumoto3315@yahoo.co.jp
Sponsor or person
Institute
Nozaki Tokushukai Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
The Tokushukai Group Ethics Committee
Address
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.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
| 2020 | Year | 10 | Month | 15 | 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
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
| 2019 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 14 | Day |
Last modified on
| 2021 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047933
