UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017185 |
|---|---|
| Receipt number | R000019891 |
| Scientific Title | The functional gait recovery with transcutaneous spinal afferent stimulation among patients with stroke |
| Date of disclosure of the study information | 2015/04/27 |
| Last modified on | 2023/10/26 11:05:40 |
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Basic information
Public title
The functional gait recovery with transcutaneous spinal afferent stimulation among patients with stroke
Acronym
Spinal stimulation for stroke
Scientific Title
The functional gait recovery with transcutaneous spinal afferent stimulation among patients with stroke
Scientific Title:Acronym
Spinal stimulation for stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the efficacy of spinal stimulation for functional gait recovery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
10m Walk speed
Key secondary outcomes
Gait analysis
Electrophysiological study
Imaging
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Transcutaneous spinal afferent stimulation
(TSAS) + hipstimulation + treadmill gait training
Interventions/Control_2
TSAS + treadmill gait training
Interventions/Control_3
treadmill gait training
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
Time from stroke onset is over 5 months
No cog nitive impairment
Position sense of lower extremity is scored 1 or more with SIAS
Half sitting is scored 5 or more with FIM like scale
SIAS hip flexion test is 1 or more
SIAS knee extension test is 1 or more
Key exclusion criteria
Severe cardiac disease
Uncontrolled hypertension
Acute illness and fever
Recent medical history of pulmonary embolism,acute corpulmonale, and severe pulmonary hypertension
Severe liver failure and renal failure
Orthopedic complication, preventing exercise
Severe cog nitive impairment and mental illness
Other metabolic disease
Patients with contraindication of electrical therapy
Pace maker user
Patients with shunt or clipping .
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Fujiwara |
Organization
Juntendo University
Division name
Rehabilitation Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
t-fujiwara@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Fujiwara |
Organization
Juntendo University
Division name
Rehabilitation Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo, Tokyo
TEL
03-3813-3111
Homepage URL
t-fujiwara@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
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
Juntendo Hospital Certified Review Board
Address
3-1-3,Hongo,Bunkyo-ku,Tokyo 113-8431 Tokyo
Tel
0 3 -5 8 0 2 -1 5 8 4
crbjun@ juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs032180289
Org. issuing International ID_1
jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 07 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 30 | Day |
Other
Other related information
The protocol of this study was changed and approved at 11 March 2019
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019891
| 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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