UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027130 |
|---|---|
| Receipt number | R000031086 |
| Scientific Title | Development of new upper limb function test method using three-dimensional motion analysis system |
| Date of disclosure of the study information | 2017/04/25 |
| Last modified on | 2021/12/01 19:29:39 |
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Basic information
Public title
Development of new upper limb function test method using three-dimensional motion analysis system
Acronym
Development of new upper limb function test method using three-dimensional motion analysis system
Scientific Title
Development of new upper limb function test method using three-dimensional motion analysis system
Scientific Title:Acronym
Development of new upper limb function test method using three-dimensional motion analysis system
Region
| Japan |
Condition
Condition
Healthy subjects,Upper limb dysfunction
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish indices to evaluate upper limb functions which are closely related the frequent movement patterns in daily life using the three-dimensional motion analysis system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Displacement, speed and acceleration of markers placed on upper limb joints and trunk.
Key secondary outcomes
Stroke Impairment Assessment Set (SIAS),Fugl-Meyer Assessment Scale (FMA),Functional Independence Measure (FIM)
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
| Maneuver |
Interventions/Control_1
To instruct the participants to perform the upper limb movement task and track the movements of markers placed on the upper limb and finger joints.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) healthy subjects
Persons aged 16 years or older with informed consent to participate the research, who had no history of upper limb dysfunction due to diseases such as stroke, neuromuscular diseases, musculoskeletal diseases.
2) upper limb dysfunction
Physically stable patients aged 16 years or older with informed consent to participate the research, who suffers from upper limb dysfunction.
Key exclusion criteria
Those who have difficulty in maintaining a sitting position for 30 minutes.
Those who have difficulty to follow instructions because of consciousness disorder/ cognitive disorder.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I,school of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Ota |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan
TEL
0562-93-9000
Homepage URL
hiro0527@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Medical Research IRB, Center for research promotion and support, Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2017 | Year | 04 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 25 | Day |
Last modified on
| 2021 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031086
