UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043570 |
|---|---|
| Receipt number | R000049759 |
| Scientific Title | The combined effects of trans-spinal direct current stimulation and neuromuscular electrical stimulation on lower limb muscle strength in patients with stroke |
| Date of disclosure of the study information | 2021/03/09 |
| Last modified on | 2021/03/09 22:23:48 |
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Basic information
Public title
A study of transcutaneous electrical stimulation over spinal and lower limb on lower limb muscle strength in patients with stroke
Acronym
A study of transcutaneous electrical stimulation over spinal and lower limb
Scientific Title
The combined effects of trans-spinal direct current stimulation and neuromuscular electrical stimulation on lower limb muscle strength in patients with stroke
Scientific Title:Acronym
The combined effects of trans-spinal direct current stimulation and neuromuscular electrical stimulation
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study is to investigate the combined effects of trans-spinal direct current stimulation and neuromuscular electrical stimulation on muscle strength recovery in patients with stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle strength of ankle dorsiflexion on affected side
Key secondary outcomes
Motor function of lower extremity
Gait ability
Surface electromyography
Gait analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
tsDCS and NMES (20 minutes, 15 sessions)
Interventions/Control_2
tsDCS and sham NMES (20 minutes, 15 sessions)
Interventions/Control_3
Sham tsDCS and NMES (20minutes, 15 sessions)
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) First episode of unilateral hemiparetic stroke occurring within the six-month period prior to enrolment
2) Stroke Impairment Assessment Scale Foot-pat-test score more than 1
3) No severe cognitive impairment (Mini-Mental State Examination: MMSE>24)
Key exclusion criteria
1) Sensory loss on affected side
2) Difficult to daily communication
3) Implanted electronic pacing or defibrillation devices
4) Sever internal and/or musculoskeletal disorders
5) Sever higher brain dysfunction and/or mental illness
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Tadaki |
| Middle name | |
| Last name | Koseki |
Organization
Yamagata saisei hospital
Division name
Department of Rehabilitation
Zip code
990-8545
Address
79-1, Okimachi, Yamagata-shi, Yamagata
TEL
023-682-1111
d.tadaki.koseki@yachts.ac.jp
Public contact
Name of contact person
| 1st name | Tadaki |
| Middle name | |
| Last name | Koseki |
Organization
Yamagata saisei hospital
Division name
Department of Rehabilitation
Zip code
990-8545
Address
79-1, Okimachi, Yamagata-shi, Yamagata
TEL
023-682-1111
Homepage URL
d.tadaki.koseki@yachts.ac.jp
Sponsor or person
Institute
Yamagata saisei hospital, Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Yamagata saisei hospital
Address
79-1, Okimachi, Yamagata-shi, Yamagata
Tel
023-682-1111
d.tadaki.koseki@yachts.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
済生会山形済生病院（山形県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 03 | Month | 09 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049759
| 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 |
