UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050859 |
|---|---|
| Receipt number | R000057954 |
| Scientific Title | Prefrontal Cortex Activity During Real-time Walking in Acute Stroke: Effects of Walking and Cognitive Function |
| Date of disclosure of the study information | 2023/04/16 |
| Last modified on | 2023/04/16 23:08:18 |
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Basic information
Public title
Prefrontal Cortex Activity During Real-time Walking in Acute Stroke: Effects of Walking and Cognitive Function
Acronym
Prefrontal Cortex Activity During Real-time Walking in Acute Stroke
Scientific Title
Prefrontal Cortex Activity During Real-time Walking in Acute Stroke: Effects of Walking and Cognitive Function
Scientific Title:Acronym
Prefrontal Cortex Activity During Real-time Walking in Acute Stroke
Region
| Japan |
Condition
Condition
Acute stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to characterize prefrontal cortex activity during dual task walking after stroke onset by comparing acute stroke patients with healthy controls. In addition, we will examine whether the presence or absence of walk and cognitive decline affects this in acute stroke patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
oxyhemoglobin concentration in the prefrontal cortex during each task will be measured using functional near infrared spectroscopy in acute stroke patients within 14 days of onset and healthy elderly subjects.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Acute stroke patients
1. Patients undergoing rehabilitation intervention at Kobe City Medical Center General Hospital
2. Patients whose physicians decide to start weaning based on clinical criteria
3. Patients who are 20 years of age or older
4. Patients who do not require walking assistance (FIM-walk >= 6)
5. Patients who were ambulatory and independent in the community before the onset of illness.
6. First stroke
7. Patients who meet the criteria 1-6 and whose consent to participate in the study was obtained during hospitalization.
healthy elderly
1. who live in the community
2. who self-report as healthy
3. who are at least 20 years of age
4. who have obtained consent to participate in the research
Key exclusion criteria
Acute stroke patients
1. patients with cognitive impairment (MMSE < 21)
2. patients with neurological diseases other than post-stroke sequelae
3. patients with uncontrolled hypertension
4. patients with leg pain to the extent that it interferes with walking
5. patients with severe obesity (BMI > 40)
6. congestive heart failure, severe valvular disease, history of cardiac arrest, presence of an implantable cardioverter-defibrillator, uncontrolled angina or other macrovascular disease, and history of myocardial infarction or cardiac surgery within 1 year
7. patients on corticosteroids
8. patients with respiratory disease requiring oxygen therapy
9. Patients with renal disease requiring dialysis
10. patients with significant visual or vestibular disturbances that affect safe ambulation
11. patients with lower motor neuron impairment 12. patients with fractures or artifacts within 6 months
12. patients who have had a fracture or joint replacement within the past 6 months
13. patients with terminal cancer
14. patients who are deemed inappropriate for participation in the study by the principal investigator or study investigators.
healthy elderly
1. with cognitive impairment (MMSE < 21)
2. with neurological disease
3. with mental illness
4. who have a disease that affects mobility
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | Tomoya |
| Middle name | |
| Last name | Takahashi |
Organization
Graduate school, Niigata University of Health and Wellfare
Kobe City Medical Center General Hospital
Division name
Rehabilitation Technology Department
Zip code
651-0071
Address
301 Centervillage, 3-1-7 Minatojima Minamimachi, Chuo-ku, Kobe City
TEL
080-7826-7024
tomjpn99@gmail.com
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Takahashi |
Organization
Kobe City Medical Center General Hospital
Division name
Rehabilitation Technology Department
Zip code
650-0047
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe City
TEL
078-302-4321
Homepage URL
tomjpn99@gmail.com
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
Kobe City Medical Center General Hospital
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 City Medical Center General Hospital
Address
2-1-1 Minatojima Minamimachi, Chuo-ku, Kobe City
Tel
078-302-4321
tomjpn99@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
| 2023 | Year | 04 | 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
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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2023 | Year | 04 | Month | 16 | Day |
Last modified on
| 2023 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057954
