UMIN-CTR Clinical Trial

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
Email	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
Email	nozaki_fukumoto3315@yahoo.co.jp

Sponsor
Institute	Nozaki Tokushukai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047933