UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014043 |
|---|---|
| Receipt number | R000016336 |
| Scientific Title | Development of a clinical evaluation scale of upper extremity-related ADL in patients with hemiparetic stroke. |
| Date of disclosure of the study information | 2014/05/30 |
| Last modified on | 2017/04/25 08:53:20 |
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Basic information
Public title
Development of a clinical
evaluation scale of upper extremity-related ADL in patients with hemiparetic stroke.
Acronym
Development of a clinical
evaluation scale of upper extremity-related ADL in patients with hemiparetic stroke.
Scientific Title
Development of a clinical
evaluation scale of upper extremity-related ADL in patients with hemiparetic stroke.
Scientific Title:Acronym
Development of a clinical
evaluation scale of upper extremity-related ADL in patients with hemiparetic stroke.
Region
| Japan |
Condition
Condition
STROKE
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To develop a clinical scale to evaluate upper extremity-related ADL(folding a towel,carrying a cup to mouth and opening a plastic bottle) easily and quantitatively.
2) To verify its reliability, validity and responsiveness.
Basic objectives2
Others
Basic objectives -Others
Motion Analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Basic information of patients with stroke (age and sex)
2)Clinical parameters related with stroke (type,lesion site, duration after stroke, complications)
3)Parameters related with impairments and disabilities (severity of motor paralysis, sensory dysfunction and contractures, higher brain disfunction, level of ADL independence, utility of upper extremity)
4) Movie samples of ADL motions (duration, smoothness, accuracy, achievement of motions; componets of motions)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Over 20 years old
2)Hemiparesis due to unilateral hemispheric lesion
3)With motor dysfunctions of the upper extremity
4)150days and over from stroke onset
5)Can keep sitting by oneself
6)Without higher cortical dysfunctions
7)Range of motion of the affected upperfextremity: shoulder flexion ovre90,delbow extension over-40,finger extension0
8)Without severe pain of the affected upper extremity
9)Without severe deep sensory disturbance
10)Movies of the ADL motions are available
Key exclusion criteria
/The clinical evaluation is difficult
/Unstable medical conditions
/Contraindications to upper
extremity exercises
1)Severe heart failure
2)Poorly controlled hypertension
3)Acute systemic disease or fever
4)Acute pulmonary embolism
5)Severe hepatic dysfunction and renal dysfunction
6)Orthopedic diseases which may interfere upper extremity functions
7)With severe cognitive and mental disorders
8)With metabolic disorders (such as acute thyroiditis)
Target sample size
20
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 Nishimoto |
Organization
Graduate School of Medicine, Keio University,Japan
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo,Japan
TEL
03-5363-3833
Homepage URL
sakurasaku710eena@gmail.com
Sponsor or person
Institute
Keio University School of Medicine,Japan
Institute
Department
Personal name
Funding Source
Organization
Strategic Research Program for Brain Sciences
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(東京都） KEIO UNIVERSITY HOSPITAL,TOKYO,JAPAN
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 30 | 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 | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study.Inter-rater and Inter-rater reliability of the clinical evaluation scale of upper extremity-related ADLis evaluated with weighted k and ICC.Concurrent validity is evaluated with Spearman's rank correlation method.
Responsiveness to changes with rehabilitation interventions is evaluated with standard response mean and Wilcoxon signed rank test.
Management information
Registered date
| 2014 | Year | 05 | Month | 22 | Day |
Last modified on
| 2017 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016336
