UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042549 |
|---|---|
| Receipt number | R000048549 |
| Scientific Title | Effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia |
| Date of disclosure of the study information | 2020/11/25 |
| Last modified on | 2020/11/24 15:40:47 |
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Basic information
Public title
Effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Acronym
Effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Scientific Title
Effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Scientific Title:Acronym
Effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Region
| Japan |
Condition
Condition
Post-Stroke Hemiplegic Patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gravity and accelerometer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In addition to standard physiotherapy (flexibility increase, muscle strengthening, balance exercise, walking exercise), center of gravity movement exercise and step exercise using IVES (tibialis anterior muscle, soleus muscle stimulation) are performed for 2 groups of subjects.
Interventions/Control_2
One session is 20 minutes, 3 times a week for a total of 2 weeks.
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
| 45 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Person is gait without assistance
Key exclusion criteria
Person has Serious higher brain dysfunction and tive dicline cognitive function
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Sakai |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Zip code
113-8510
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
0338136111
onuma.reh@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Onuma |
Organization
Tokyo Medical and Dental University
Division name
1-5-45 Yushima Bunkyo-ku Tokyo
Zip code
0338136111
Address
1-5-45 Yushima Bunkyo-ku Tokyo
TEL
0338136111
Homepage URL
onuma.reh@tmd.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
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
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Address
1-5-45 Yushima Bunkyo-ku Tokyo
Tel
0338136111
onuma.reh@tmd.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
| 2020 | Year | 11 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 25 | Day |
Last modified on
| 2020 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048549
