UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043957 |
|---|---|
| Receipt number | R000050206 |
| Scientific Title | Effect of early walking intervention on psychological and cognitive functions in patients with stroke |
| Date of disclosure of the study information | 2021/04/17 |
| Last modified on | 2021/04/17 20:09:57 |
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Basic information
Public title
Effect of early walking intervention on psychological and cognitive functions in patients with stroke
Acronym
Effect of early walking intervention on psychological and cognitive functions in patients with stroke
Scientific Title
Effect of early walking intervention on psychological and cognitive functions in patients with stroke
Scientific Title:Acronym
Effect of early walking intervention on psychological and cognitive functions in patients with stroke
Region
| Japan |
Condition
Condition
patient with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate psychological and cognitive effects of early gait training on hospitalized patients with stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mood
Key secondary outcomes
depression, cognitive function, physical function
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
Treatment
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Provide physical therapy including gait training for 20 minutes or more to patients with low motivation and those with maintained motivation.
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
1)Patients who perform gait training for 20 minutes or more in a single intervention by a physical therapist
2)Patients who had a first stroke
3)Patients who have been admitted to a recovery ward for less than 30 days
4)Patients with lower limb dysfunction due to hemiparesis
5)Patients who require assistance for standing or walking
6)Patients who don't have severe communication difficulties
Key exclusion criteria
1)Patients who have difficulty in communication
2)Patients who have been walking independently since admitting to the hospital
3)Patients who are able to walk independently but require monitoring due to attention disorders, etc.
4)Patients whose conditions are not stable or who do not have first strokes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Maeda |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
TEL
078-792-2555
208k218k@stu.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Hayashi |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
TEL
078-792-2555
Homepage URL
a-hayashi@pearl.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
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
Kobe University
Address
7-10-2 Tomogaoka, Suma-ku, Kobe, Japan
Tel
078-792-2555
a-hayashi@pearl.kobe-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
社会医療法人 清風会
五日市記念病院（広島県）、廿日市記念病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 17 | 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
| 2021 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 04 | Month | 17 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050206
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
