UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043620 |
|---|---|
| Receipt number | 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 08:43:20 |
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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
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
kiyoshi.yoshioka.y@gmail.com
Sponsor or person
Institute
Rehabilitation Center for all Customers with Stroke and Cerebrovascular Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049808
