UMIN-CTR Clinical Trial

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

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	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

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