UMIN-CTR Clinical Trial

Basic information
Public title	Development of a new assessment tool for promoting upper limb functional ability in patients with stoke
Acronym	A new assessment tool for promoting upper limb functional ability in patients with stoke
Scientific Title	Development of a new assessment tool for promoting upper limb functional ability in patients with stoke
Scientific Title:Acronym	A new assessment tool for promoting upper limb functional ability in patients with stoke
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the reliability, validity, and utility of a new assessment tool
Basic objectives2	Others
Basic objectives -Others	To examine the reliability, validity, and utility of a new assessment tool
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Results of a new assessment tool (time required and score for each task in the assessment)
Key secondary outcomes	Assessments of impairments and activity for the upper limb paresis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Evaluation of upper limb functional ability with a new assessment tool
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	[Patients] 1. Patients with first-ever hemiparetic stroke 2. Able to understand the study purpose and method 3. Able to sit, stand, and walk with or without functional aids including orthosis 4. Consent to participate in the study [Healthy individuals] 1. No neurological and musculoskeletal impairments that limit the activities of daily tasks 2. Consent to participate in the study
Key exclusion criteria	[Patients] 1. Difficulties in using the upper limbs due to pain 2. Apparent motor impairments in the unaffected upper limb 3. Contraindications of exercises [Healthy individuals] 1. Pain in the upper limbs 2. Contraindications of exercises
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Middle name Last name Michiyuki Kawakami
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3833
Email	michiyukikawakami@hotmail.com

Public contact
Name of contact person	1st name Middle name Last name Yohei Otaka
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3833
Homepage URL
Email	otaka119@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	National Institute of Information and Communications Technology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2017 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	Terminated
Date of protocol fixation	2016 Year 12 Month 20 Day
Date of IRB	2017 Year 02 Month 06 Day
Anticipated trial start date	2017 Year 02 Month 13 Day
Last follow-up date	2021 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 02 Month 07 Day
Last modified on	2019 Year 03 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029922

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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