UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013100 |
|---|---|
| Receipt number | R000015268 |
| Scientific Title | Evaluation of reaching in patients with hemiparetic stroke: construction of a clinical motion analysis system |
| Date of disclosure of the study information | 2014/02/07 |
| Last modified on | 2017/04/27 21:17:40 |
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Basic information
Public title
Evaluation of reaching in patients with hemiparetic stroke: construction of a clinical motion analysis system
Acronym
Motion analysis of reaching in patients with hemiparetic stroke
Scientific Title
Evaluation of reaching in patients with hemiparetic stroke: construction of a clinical motion analysis system
Scientific Title:Acronym
Motion analysis of reaching in patients with hemiparetic stroke
Region
| Japan |
Condition
Condition
Patients with upper limb impairments and healthy persons
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To develop a practical and clinically relevant kinematic motion analysis system, and to verify its reliability, validity, responsiveness and practicability
2) To investigate reaching impairment in patients with stroke with the system we will develop, and to evaluate its relation with clinical factors
Basic objectives2
Others
Basic objectives -Others
Motion analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reaching movement parameters in healthy persons and patients with stroke using motion analysis system
(time needed, acceleration, velocity, displacement, joint angle, muscle activity and so on)
Key secondary outcomes
Subjective evaluation of the burden imposed by wearing the system with visual analog scale(VAS) or free comments
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
| Device,equipment |
Interventions/Control_1
Evaluation of reaching with a motion analysis system
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients
1.Over 20 years old
2.Hemiparesis due to unilateral hemispheric lesion
3.With motor dysfunction of upper extremity
4.30 days and over from stroke onset
5.Can keep sitting by oneself
6.Without higher cortical dysfunctions
7.Range of motion of the affected upper extremity; shoulder flexion more than 90 degrees ,elbow extension more than -40 degrees ,finger extension more than 0 degree
8.Without severe pain of the affected upper extremity
9.Without severe deep sensory disturbance
10.Agreed to participate in the study
healthy persons:
1.Without past histories of musculoskeletal system (the arms) and neurologic diseases
2.Agreed to participate in the study
Key exclusion criteria
1)A pacemaker implanted
2)Contraindications to upper extremity exercise
1.Severe heart failure
2.Poorly controled hypertension
3.Acute systemic disease or fever
4.Acute pulmonary embolism, cor pulmonale, severe pulmonary hypertension
5.Severe hepatic dysfunction and renal dysfunction
6.Orthopedic diseases which may disturb upper extremity functions
7.With severe cognitive and mental disorders
8.With metabolic disorders such as acute thyroiditis
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Meigen Liu |
Organization
Keio University School of Medicine, Japan
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
0353633833
meigenliukeio@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Horie |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-5363-3833
Homepage URL
atsukohorie7@gmail.com
Sponsor or person
Institute
Keio University School of Medicine, Japan
Institute
Department
Personal name
Funding Source
Organization
National model research and development promotion business for problem
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
慶應義塾大学病院 KEIO UNIVSRSITY HOSPITAL
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 07 | 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
| 2014 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 07 | 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
| 2014 | Year | 02 | Month | 07 | Day |
Last modified on
| 2017 | 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=R000015268
