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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043620
Receipt No. R000049808
Scientific Title A study on the effect of individually supervised rehabilitation intervention on gait in chronic stroke patients
Date of disclosure of the study information 2021/03/16
Last modified on 2021/03/16

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Basic information
Public title A study about the effectiveness of rehabilitation intervention for patients with cerebrovascular disease in the maintenance/living phase
Acronym Effectiveness of chronic stroke rehabilitation
Scientific Title A study on the effect of individually supervised rehabilitation intervention on gait in chronic stroke patients
Scientific Title:Acronym Effectiveness of chronic stroke rehabilitation on gait parameters
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether individually supervised exercise therapy would improve gait parameters in chronic stroke patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gait cycle, stride length, walking pitch, and walking speed
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 Treatment
Type of intervention
Other
Interventions/Control_1 Exercise therapy
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 with stroke for at least 6 months who are using a self-pay rehabilitation facility for the first time.
Those who can walk 5 m by themselves.
Key exclusion criteria Those with cerebellar ataxia
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Yoshioka
Organization Rehabilitation Center for all Customers with Stroke and Cerebrovascular Diseases
Division name Kumamoto center
Zip code 862-0971
Address Ooe 4-2-1, Chuoh-ku, kumamoto
TEL 096-327-9810
Email kiyoshi.yoshioka.y@gmail.com

Public contact
Name of contact person
1st name Kiyoshi
Middle name
Last name Yoshioka
Organization Rehabilitation Center for all Customers with Stroke and Cerebrovascular Diseases
Division name Kumamoto center
Zip code 862-0971
Address Ooe 4-2-1, Chuoh-ku, kumamoto
TEL 096-327-9810
Homepage URL
Email kiyoshi.yoshioka.y@gmail.com

Sponsor
Institute Rehabilitation Center for all Customers with Stroke and Cerebrovascular Diseases
Institute
Department

Funding Source
Organization the Higo Foundation for Promotion of Medical Education and Research
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Rehabilitation Center for all Customers with Stroke and Cerebrovascular Diseases
Address Ooe 4-2-1, Chuoh-ku, kumamoto
Tel 096-327-9810
Email kiyoshi.yoshioka.y@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
2021 Year 03 Month 16 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 25
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
2019 Year 04 Month 01 Day
Date of IRB
2019 Year 08 Month 16 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2020 Year 12 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
2021 Year 03 Month 16 Day
Last modified on
2021 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049808

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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