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Recruitment status Completed
Unique ID issued by UMIN UMIN000014043
Receipt No. R000016336
Official scientific title of the study 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

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Basic information
Official scientific title of the study Development of a clinical
evaluation scale of upper extremity-related ADL in patients with hemiparetic stroke.
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 Meigen Liu
Organization Keio University School of Medicine,Japan
Division name Department of Rehabilitation Medicine
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo,Japan
TEL 03-5363-3833
Email meigenliukeio@mac.com

Public contact
Name of contact person Atsuko Nishimoto
Organization Graduate School of Medicine, Keio University,Japan
Division name Department of Rehabilitation Medicine
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo,Japan
TEL 03-5363-3833
Homepage URL
Email sakurasaku710eena@gmail.com

Sponsor
Institute Keio University School of Medicine,Japan
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 28 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016336


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