UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015721 |
|---|---|
| Receipt number | R000018267 |
| Scientific Title | The effect of neuro-rehabilitation on walking ability after stroke |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2022/05/31 14:31:41 |
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Basic information
Public title
The effect of neuro-rehabilitation on walking ability after stroke
Acronym
The effect of neuro-rehabilitation on walking ability after stroke
Scientific Title
The effect of neuro-rehabilitation on walking ability after stroke
Scientific Title:Acronym
The effect of neuro-rehabilitation on walking ability after stroke
Region
| Japan |
Condition
Condition
Cerebrovascular diseases
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this study are to examine the effect of action observation treatment on motor function and walking ability
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Brunnstrom stage
Wisconsin gait scale
Key secondary outcomes
Functional magnetic resonance imaging
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Action observation treatment
Interventions/Control_2
Normal rehabilitation
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
| 18 | years-old | <= |
Age-upper limit
| 76 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Ischemic or hemorrhagic stroke patients
2) 7 to 14 days from onset
3) Motor weakness of the lower extremities(Brunnstrom stage is more than II)
4) Sitting position possible
5) age of the patient is more than 18 and less than 76 at the date of registration
6) informed consent was obtained from the patient
Key exclusion criteria
1) patients with a history of cerebrovascular diseases
2) patients with orthopedic disease of the lower extremities
3) patients with severe neglect
4) patients with visual dysfunction
5) patients with severe cognitive dysfunction
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Nagahiro |
Organization
University of Tokushima
Division name
Neurosurgery
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-7149
neuros@clin.med.tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiteru |
| Middle name | |
| Last name | Tada |
Organization
University of Tokushima
Division name
Neurosurgery
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima
TEL
088-633-7149
Homepage URL
neuros@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
University of Tokushima, Department of Neurosurgery
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Taoka hospital
Nakasuyagi hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tokushima, Department of Neurosurgery
Address
3-18-15, Kuramoto-cho, Tokushima
Tel
088-633-7149
neuros@clin.med.tokushima-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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32234334/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32234334/
Number of participants that the trial has enrolled
16
Results
A split plot design analysis of covariance revealed no significant interactions between the assessment time and group in FAC and 10-meter walk test. However, the action observation treatment group (but not the control group) exhibited significant improvements in the 10-meter walk test the participants who could walk independently.
Results date posted
| 2022 | Year | 05 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were patients who had been admitted to the stroke care unit of Tokushima University Hospital from December 2014 to April 2018. Exclusion criteria were stroke patients with a prior history of stroke, unilateral spatial neglect, visual impairment that interfered with the study protocol, major cognitive problems, and orthopedic disease of the lower limbs.
Participant flow
Participants were patients who had been admitted to the stroke care unit of Tokushima University Hospital from December 2014 to April 2018. We explained the purpose and procedure of the study to participants and received written informed consent from all participants.
Adverse events
None.
Outcome measures
Functional Ambulation Classification
10-meter walk test
Brunnstrom stage
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2014 | Year | 11 | Month | 19 | Day |
Last modified on
| 2022 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018267
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| Registered date | File name |
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