UMIN-CTR Clinical Trial

Basic information
Public title	The association between anatomical change in quadriceps femoris muscle and activities of daily living in physically challenged persons.
Acronym	The association between anatomical change in quadriceps femoris muscle and activities of daily living in physically challenged persons.
Scientific Title	The association between anatomical change in quadriceps femoris muscle and activities of daily living in physically challenged persons.
Scientific Title:Acronym	The association between anatomical change in quadriceps femoris muscle and activities of daily living in physically challenged persons.
Region	Japan

Condition
Condition	lower limb amputation, cerebrovascular disease, traumatic brain injury, Lower extremity fractures
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The main purpose of this study is to assess anatomy in quadriceps femoris muscle in challenged persons
Basic objectives2	Others
Basic objectives -Others	The second purpose of this study is to assess the effects of anatomical and qualitative change in quadriceps femoris muscle on activities of daily living in physically challenged persons.
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Ultrasonography (muscle thickness, muscle cross sectional area, muscle volume, echo intensity)
Key secondary outcomes	height, weight, lower limb length, motor function test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Disabled lower limb: Ultrasonography (lower limb amputation, cerebrovascular disease, traumatic brain injury, lower extremity fracture), physical examination (height, body mass, lower limb length), motor function test
Interventions/Control_2	Contralateral limb: Ultrasonography (lower limb amputation, cerebrovascular disease, traumatic brain injury, lower extremity fracture), physical examination (height, body mass, lower limb length), motor function test
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	physically challenged persons (lower limb amputation, cerebrovascular disease, traumatic brain injury, lower extremity fracture)
Key exclusion criteria	Cognitive impairment, Disturbance of consciousness, higher brain dysfunction, malignant tumor, severe disease, total hip replacement , total knee replacement
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Ishida Koji
Organization	Nagoya University
Division name	Research center of health, physical fitness and sports
Zip code
Address	Furo-cho, Chikusa-ku, Nagoya, Aichi, Japan
TEL	052-788-6258
Email	ishida@htc.nagoya-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Maeda Hisashi
Organization	Graduate School of Medicine, Nagoya University
Division name	Program in Integrated Medicine
Zip code
Address	65 Tsurumai, Showa-ku, Nagoya, aichi, Japan
TEL	052-788-5927
Homepage URL
Email	maeda.hisashi@nagoya-u.ac.jp

Sponsor
Institute	Nagoya university
Institute
Department

Funding Source
Organization	none
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
Address
Tel
Email

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	2017 Year 04 Month 01 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
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	2017 Year 03 Month 30 Day
Date of IRB	2017 Year 07 Month 12 Day
Anticipated trial start date	2017 Year 08 Month 24 Day
Last follow-up date	2020 Year 03 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 03 Month 30 Day
Last modified on	2020 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030748