UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029948 |
|---|---|
| Receipt number | R000034208 |
| Scientific Title | The effects of electrical stimulation combined with voluntary contraction on motor function in affected leg in patients with stroke |
| Date of disclosure of the study information | 2017/11/13 |
| Last modified on | 2025/03/12 12:29:04 |
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Basic information
Public title
The effects of electrical stimulation combined with voluntary contraction on motor function in affected leg in patients with stroke
Acronym
The effects of electrical stimulation combined with voluntary contraction on lower limb paralysis after stroke
Scientific Title
The effects of electrical stimulation combined with voluntary contraction on motor function in affected leg in patients with stroke
Scientific Title:Acronym
The effects of electrical stimulation combined with voluntary contraction on lower limb paralysis after stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of patterned electrical stimulation (PES) combined with voluntary contraction on motor function in affected leg and spinal reciprocal inhibition in patients with stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor function (Fugl-Meyer assessment, Stroke Impairment Assessment Set)
Key secondary outcomes
Spasticity(E-SAM), spinal reciprocal inhibition, motion analysis
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
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PES combined with voluntary contraction (20 min/day, 10 days)
Interventions/Control_2
Voluntary contraction alone (20 min/day, 10 days)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.First cerebral infarction or hemorrhage with single lesion
2.from 30 to 90 days after the stroke
3.Able to understand daily communication
4.Stroke Impairment Assessment Set (SIAS) Foot-pat test score is in the range from 2 to 4
5.Able to walk without any cane, brace, or assistance for 15m
6.Modified Ashworth scale (MAS) score is 2 or less
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
50
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
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
y.takahashi.jk@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
183
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
| 2017 | Year | 11 | 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
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
Suspended
Date of protocol fixation
| 2017 | Year | 11 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 13 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034208
