UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034580 |
|---|---|
| Receipt number | R000039417 |
| Scientific Title | Immediate effect of gait training with functional electrical stimulation to the tibialis anterior and the gluteus medius on the gait pattern in patients with stroke |
| Date of disclosure of the study information | 2018/10/20 |
| Last modified on | 2022/04/03 13:20:58 |
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Basic information
Public title
Immediate effect of gait training with functional electrical stimulation to the tibialis anterior and the gluteus medius on the gait pattern in patients with stroke
Acronym
Immediate effect of gait training with functional electrical stimulation on the gait pattern in stroke patients
Scientific Title
Immediate effect of gait training with functional electrical stimulation to the tibialis anterior and the gluteus medius on the gait pattern in patients with stroke
Scientific Title:Acronym
Immediate effect of gait training with functional electrical stimulation on the gait pattern in stroke patients
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the immediate effect of gait training with functional electrical stimulation to the tibialis anterior and the gluteus medius on the gait pattern in patients with stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10m walk test
Key secondary outcomes
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
Gait training with functional electrical stimulation
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Post-stroke hemiparesis
(2)The ability to walk at least 14m
(3)Stable medical condition
Key exclusion criteria
(1) Severe cardiopulmonary disease
(2) Severe sensory disturbance or severe ataxia or severe higher brain dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Sota |
| Middle name | |
| Last name | Araki s |
Organization
Acras Central Hospital
Division name
Department of rehabilitation
Zip code
890-0031
Address
1 -121-5 Takeoka,Kagoshima,Japan
TEL
099-203-0100
arakisota@gmail.com
Public contact
Name of contact person
| 1st name | sota |
| Middle name | |
| Last name | Araki |
Organization
Acras Central Hospital
Division name
Department of rehabilitation
Zip code
890-0031
Address
1 -121-5 Takeoka,Kagoshima,Japan
TEL
099-203-0100
Homepage URL
arakisota@gmail.com
Sponsor or person
Institute
Acras Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Acras Central Hospital
Address
1 -121-5 Takeoka,Kagoshima,Japan
Tel
099-203-0100
acrasreha@yahoo.co.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
| 2018 | Year | 10 | Month | 20 | 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
20
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 19 | Day |
Last modified on
| 2022 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039417
