UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034473 |
|---|---|
| Receipt number | R000039304 |
| Scientific Title | The relationship between the changes in spinal reflexes and motor function, gait pattern in patients with chronic stroke |
| Date of disclosure of the study information | 2018/10/13 |
| Last modified on | 2021/11/25 12:06:22 |
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Basic information
Public title
The relationship between the changes in spinal reflexes and motor function, gait pattern in patients with chronic stroke
Acronym
The relationship between spinal reflexes and gait pattern after chronic stroke
Scientific Title
The relationship between the changes in spinal reflexes and motor function, gait pattern in patients with chronic stroke
Scientific Title:Acronym
The relationship between spinal reflexes and gait pattern after chronic stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between the changes in spianl reflexes (heteronymous facilitation, reciprocal inhibition) and motor funcion in affected leg, abnormal gait pattern in patients with chronic stroke.
Basic objectives2
Others
Basic objectives -Others
cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
heteronymous facilitation, reciprocal inhibition
Key secondary outcomes
Motor function (Fugl-Meyer assessment, Stroke Impairment Assessment Set), Spasticity (Modified Ashworth scale, E-SAM), gait (video analysis)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.First cerebral infarction or hemorrhage with single lesion
2.over 180 days after the onset of stroke
3.Modified Ashworth scale (MAS) score is 2 or less
4.Functional Independence Measure (FIM) walking score is 3 or more
5.Able to come to hospital independently
6.Comminication possible
7.Agreement to participate in the study
Key exclusion criteria
1.Medical history of orthopedic disease of leg
2.Medical history of diabetic peripheral neuropathy
3.Implanted electronic pacing or defibrillation devices
4.Receiving antispastic medication during participation in the study
5.Sensory loss on affected leg
6.Stop by primary doctor
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
047-453-9000
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
047-453-9000
Homepage URL
matsuda_y@a6.keio.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
Self funding
Nationality of Funding Organization
Japan
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
YES
Study ID_1
194
Org. issuing International ID_1
Tokyo Bay Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京湾岸リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 13 | 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
16
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We test the relationship among each evaluation factor at the same time. We compare the state of evaluations with that in patients with sub-acute stroke.
Management information
Registered date
| 2018 | Year | 10 | Month | 12 | Day |
Last modified on
| 2021 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039304
| 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 |
