UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026784 |
|---|---|
| Receipt number | R000030748 |
| Scientific Title | The association between anatomical change in quadriceps femoris muscle and activities of daily living in physically challenged persons. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/04/27 21:44:50 |
* 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
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
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
maeda.hisashi@nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030748
