UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053743 |
|---|---|
| Receipt number | R000061334 |
| Scientific Title | Relationship between autonomic nerve function and paralyzed upper limb function in convalescent stroke rehabilitation patients -A preliminary study |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2025/09/01 09:46:40 |
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Basic information
Public title
Evaluation of autonomic nervous system function in stroke patients
Acronym
Evaluation of autonomic nervous system function in stroke patients
Scientific Title
Relationship between autonomic nerve function and paralyzed upper limb function in convalescent stroke rehabilitation patients -A preliminary study
Scientific Title:Acronym
Relationship between autonomic nerve function and paralyzed upper limb function in convalescent stroke rehabilitation patients -A preliminary study
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the relationship between changes in heart rate variability and upper extremity motor function during upper extremity functional assessment and at rest.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to examine the relationship between changes in heart rate variability and upper extremity motor function during upper extremity functional assessment and at rest
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment(Upper extremity)
Key secondary outcomes
Grip power, Modified Ashworth Scale, Box and Block test
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
| Device,equipment |
Interventions/Control_1
ECG to evaluate autonomic function
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with cerebral infarction and cerebral hemorrhage (excluding subarachnoid hemorrhage)
2) Patients who are hospitalized for first-ever stroke and have no recurrence, (excluding those who have no symptoms and were found incidentally on imaging tests).
3) Patients with unilateral cerebral hemispheric lesion
4) Patients over 20 years old
5) Patients who were admitted to this hospital within 2 months after the onset of the stroke
6) Patients undergoing convalescent rehabilitation
7) Patients with SIAS (Stroke Impairment Assessment Set) knee-mouth test of 1 or more and finger-function test of 1a or more.
8) Patients with MMSE of 24 points or more at the time of admission
9) Patients who can be evaluated for upper limb function in a sitting position
Key exclusion criteria
1) Patients with a history of arrhythmia
2) Patients with a history of heart, aortic or carotid artery surgery
3) Patients with severe complications
4) Patients with a history of trauma, surgery, or disease that may affect the movement of the paralyzed upper limb
5) Patients with a history of neurological disease
6) Patients with suspected diabetic neuropathy
7) Patients who are taking beta blockers
8) Patients with higher brain dysfunction such as aphasia or somatoform apraxia who cannot follow movement instructions
9) Other patients deemed ineligible as subjects by the attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsujikawa |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba, Japan
TEL
047-453-9000
tsujikawa-ma@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsujikawa |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation Medicine
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba, Japan
TEL
047-453-9000
Homepage URL
tsujikawa-ma@hotmail.co.jp
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Bay Rehabilitation 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
Tokyo Bay Rehabilitation Hospital
Address
4-1-1 Yatsu, Narashino-shi, Chiba
Tel
047-453-9000
shinsakai@wanreha.net
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
| 2024 | Year | 03 | Month | 01 | 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
4
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
Terminated
Date of protocol fixation
| 2023 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 01 | Day |
Last modified on
| 2025 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061334
