UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of the Upper Limb Rehabilitation Support System Robot for Upper Limb Paralysis after Stroke
Acronym	Effectiveness of the Upper Limb Rehabilitation Support System Robot for Upper Limb Paralysis after Stroke
Scientific Title	Effectiveness of the Upper Limb Rehabilitation Support System Robot for Upper Limb Paralysis after Stroke
Scientific Title:Acronym	Effectiveness of the Upper Limb Rehabilitation Support System Robot for Upper Limb Paralysis after Stroke
Region	Japan

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

Objectives
Narrative objectives1	We aim to improve upper limb function and increase the frequency of use of the paralyzed hand in daily life by providing stroke patients with upper limb paralysis with voluntary practice using the Upper Limb Rehabilitation Support System Robot.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fugl-Meyer Assessment
Key secondary outcomes	Motor Activity Log Simple Test for Evaluating Hand Function Active ROM

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Voluntary practice using the Upper Limb Rehabilitation Support System Robot. 40 minutes a day, Seven days a week, Two weeks
Interventions/Control_2	Control
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	Slight movement of the shoulders, elbows and fingers. Br stage: 3or 4or 5
Key exclusion criteria	Serious comorbidities. Significant pain in the shoulder or elbow. Does not understand instructions. Cannot sit in a chair for 40 minutes.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yuta Middle name Last name Noguchi
Organization	Suzuka University of Medical Science
Division name	Department of Rehabilitation, Faculty of Health Science
Zip code	510-0293
Address	Kishioka 1001-1, Suzuka City, Mie
TEL	059-383-8991
Email	reha.noguchi.ot@gmail.com

Public contact
Name of contact person	1st name Yuta Middle name Last name Noguchi
Organization	Suzuka University of Medical Science
Division name	Department of Rehabilitation, Faculty of Health Science
Zip code	510-0293
Address	Kishioka 1001-1, Suzuka City, Mie
TEL	059-383-8991
Homepage URL
Email	reha.noguchi.ot@gmail.com

Sponsor
Institute	Suzuka University of Medical Science
Institute
Department

Funding Source
Organization	Suzuka University of Medical Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Suzuka University of Medical Science
Address	Kishioka 1001-1, Suzuka City, Mie
Tel	059-340-0550
Email	isobe@suzuka-u.ac.jp

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	主体会病院

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 01 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	Enrolling by invitation
Date of protocol fixation	2020 Year 12 Month 01 Day
Date of IRB	2020 Year 07 Month 30 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2022 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 25 Day
Last modified on	2021 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047567

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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