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

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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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047933


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name