UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037792 |
|---|---|
| Receipt number | R000042801 |
| Scientific Title | Establishing a new quantification method of lower limbs movement coordination and validating the relationship with symptoms of the diseases |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2024/08/28 14:42:28 |
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Basic information
Public title
Establishing a new quantification method of lower limbs movement coordination and validating the relationship with symptoms of the diseases
Acronym
Relationship lower limbs movement coordination and symptoms of the diseases
Scientific Title
Establishing a new quantification method of lower limbs movement coordination and validating the relationship with symptoms of the diseases
Scientific Title:Acronym
Relationship lower limbs movement coordination and symptoms of the diseases
Region
| Japan |
Condition
Condition
Lower extremity orthopedic diseases
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship lower limb movement coordination of the patients who have lower extremity orthopedic disease and symptoms of diseases
Basic objectives2
Others
Basic objectives -Others
To clarify the influence of the lower limb movement coordination on the changes of symptoms before and after the surgery in the lower extremity orthopedic diseases patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematic variables of lower extremity
kinetic variables of lower extremity
Electromyographic signals of lower limb muscles
Symptoms of diseases from questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Normal gait(10 trials)
Running(10 trials)
Squat(10 trials)
Landing(10 trials)
Ascend and descend stairs(10 trials)
Stepping(10 trials)
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Persons who can walk without being helped
2.Persons who write informed consent
Key exclusion criteria
1.Persons who had a history of orthopedic operation in spine or lower limbs, or given either a diagnosis of as having a central nervous system disease, a mental disease and dementia.
2.Persons can not walk more than 10m.
3.Persons who deemed inappropriate for this study by doctor.
4.Persons relating to researchers as the student and a teacher, and attending the lecture of the study person in charge.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nobuo |
| Middle name | |
| Last name | Adachi |
Organization
Hiroshima University Hospital
Division name
Department of Orthopedic Surgery
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
082-527-5232
nadachi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Toriyama |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Sciences
Zip code
734-8551
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
TEL
082-527-5232
Homepage URL
d181008@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Saiseikai Kure Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Clinical study ethic screening committee
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima
Tel
082-257-1551
kasumi-kenkyu@office.hiroshima-u.ac.jp
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
| 2019 | Year | 09 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 24 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042801
