UMIN-CTR Clinical Trial

Basic information
Public title	The effect of cognitive neurological rehabilitation on upper limb function in home stroke patients
Acronym	The effect of cognitive neurological rehabilitation on upper limb function in home stroke patients
Scientific Title	The effect of cognitive neurological rehabilitation on upper limb function in home stroke patients
Scientific Title:Acronym	The effect of cognitive neurological rehabilitation on upper limb function in home stroke patients
Region	Japan

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

Objectives
Narrative objectives1	To determine the effect of cognitive neurological rehabilitation on upper limb function in home stroke patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fugl-Meyer Assessment upper limb Motor Activity Log
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	cognitive neuro-rehabilitation
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	Home stroke patients undergoing outpatient rehabilitation at our hospital
Key exclusion criteria	Students who have scored less than 24 points on the Mini-Mental State Examination. A person who presents with severe higher brain function Those with Central Post Stroke Pain Those who are unable to give consent to participate in this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Nakagawa Middle name Last name Kotaro
Organization	Kawaguchi Neurosurgery Rehabilitation Clinic
Division name	Department of Rehabilitation
Zip code	5730086
Address	9-25-202 Korizono-cho, Hirakata City, Osaka
TEL	0728351010
Email	kawaguchi.ns.reha@gmail.com

Public contact
Name of contact person	1st name Iki Middle name Last name Shinya
Organization	Kawaguchi Neurosurgery Rehabilitation Clinic
Division name	Department of Rehabilitation
Zip code	5730086
Address	9-25-202 Korizono-cho, Hirakata City, Osaka
TEL	0728351010
Homepage URL	https://kawaguchi-ns.com/
Email	kawaguchi.ns.reha@gmail.com

Sponsor
Institute	Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department

Funding Source
Organization	none
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	Kawaguchi Neurosurgery Rehabilitation Clinic
Address	9-25-202 Korizono-cho, Hirakata City, Osaka
Tel	0728351010
Email	kawaguchi.ns.reha@gmail.com

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	2020 Year 06 Month 10 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	8
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	2020 Year 02 Month 21 Day
Date of IRB	2020 Year 02 Month 21 Day
Anticipated trial start date	2020 Year 02 Month 21 Day
Last follow-up date	2020 Year 12 Month 18 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 06 Month 09 Day
Last modified on	2020 Year 12 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046468