UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033772 |
|---|---|
| Receipt number | R000038485 |
| Scientific Title | Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients |
| Date of disclosure of the study information | 2018/08/16 |
| Last modified on | 2019/09/17 16:32:41 |
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Basic information
Public title
Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients
Acronym
Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients
Scientific Title
Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients
Scientific Title:Acronym
Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients
Region
| Japan |
Condition
Condition
hemiplegic patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to Examine the effect of using IVES for hemiplegic patients with cerebrovascular disorder admitted to the rehabilitation ward of the Chiba Tokushukai Hospital
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Active-range of motion of ankle dorsiflex
Key secondary outcomes
Passive-range of motion of ankle dorsiflex
Muscular strength of ankle dorsiflexor muscle by the Hand-Held Daynamomater
6-Minute Walk Test (6MWT)
Fugl-Meyer Assessment
Brunnstrom recovery stage
IVES settings
Modified Ashworth Scale
Amount of assistance for walking
Maximum Gait speed
stride
Gait rate
Angle transition of ankle dorsiflexion during standing
Angle transition of ankle dorsiflexion during Gait
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
IVES
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
hemiplegic patients
Level IV or higher on lower limb BRS
Patient who able to keep sitting or standing position by watching or self-reliance
Patients who can practice gait training assisted by occupational therapists or physical therapists
Key exclusion criteria
Severe aphasia , Severe dementia
Patients who cannot working IVES (Abandonment , Disapproval , Complete sensory paralysis)
Patients who are judged as difficult to gait by the doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kikuko Ikeda |
Organization
CHIBA TOKUSHUKAI HOSPITAL
Division name
Rehabilitation
Zip code
Address
2-11-1 Takanedai,Funabasi-shi,Chiba,Japan
TEL
047-466-7111
xgmny681@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahisa Kotaki |
Organization
CHIBA TOKUSHUKAI HOSPITAL
Division name
Rehabilitation
Zip code
Address
2-11-1 Takanedai,Funabasi-shi,Chiba,Japan
TEL
047-466-7111
Homepage URL
t.kotaki1012@gmail.com
Sponsor or person
Institute
CHIBA TOKUSHUKAI HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
CHIBA TOKUSHUKAI HOSPITAL
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
Address
Tel
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 | 08 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 15 | Day |
Last modified on
| 2019 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038485
