UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027706 |
|---|---|
| Receipt number | R000031737 |
| Scientific Title | Development of a clinical reaching assessment scale for patients with hemiparetic stroke-prospective study- |
| Date of disclosure of the study information | 2017/06/12 |
| Last modified on | 2019/03/26 21:54:44 |
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Basic information
Public title
Development of a clinical reaching assessment scale for patients with hemiparetic stroke-prospective study-
Acronym
Development of a clinical reaching assessment scale for patients with hemiparetic stroke-prospective study-
Scientific Title
Development of a clinical reaching assessment scale for patients with hemiparetic stroke-prospective study-
Scientific Title:Acronym
Development of a clinical reaching assessment scale for patients with hemiparetic stroke-prospective study-
Region
| Japan |
Condition
Condition
patients with hemiparetic stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify reliability, validity, and responsiveness of the reaching assessment scale which we developed.
Basic objectives2
Others
Basic objectives -Others
Psychometric properties
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Inter-rater reliability
Intra-rater reliability
Concurrent validity with the severity of upper-extremity motor paralysis, spasticity and so on.
responsiveness
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1) Over 20 years old
2) Hemiparesis due to unilateral hemispheric lesion
3) With motor dysfunction of upper extremity
4) 150 days and over from stroke onset
5) Can keep sitting by oneself
6) Without higher cortical dysfunctions that hinder clinical assessment
7) Range of motion of the affected upper extremity : shoulder flexion over 90 degrees,elbow extension over -40 degrees,finger extension over 0 degree
8) Without severe pain of the affected upper extremity
9) Without severe deep sensory disturbance
Key exclusion criteria
Contraindications to upper extremity exercise (details as described below)
1)Severe heart diseases such as unstable angina, recent onset myocardial infarction, decompensated congestive heart failure, acute core pulmonare, poorly controlled arrythmia, severe aortic valvular disease, active myocarditis, pericarditis and so on.
2)Poorly controlled 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
03-5363-3833
meigenliukeio@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Nishimura |
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
Institute
Department
Personal name
Funding Source
Organization
AMED
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
慶應義塾大学医学部リハビリテーション医学教室
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 12 | 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 | 06 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
classification of sex, age, disease type of stroke, lesions caused by stroke, medical treatment, disease duration, motor dysfunction, sensory dysfunction, spasticity, range of motion, higher brain dysfunction and so on
Management information
Registered date
| 2017 | Year | 06 | Month | 09 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031737
