UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036573 |
|---|---|
| Receipt number | R000041669 |
| Scientific Title | Validation of the effect of foot drop suppression equipment for stroke hemiplegia. |
| Date of disclosure of the study information | 2019/04/22 |
| Last modified on | 2019/04/22 15:19:40 |
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Basic information
Public title
Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Acronym
Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Scientific Title
Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Scientific Title:Acronym
Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Region
| Japan |
Condition
Condition
Stroke hemiplegia
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the rehabilitation effect of the device to prevent the foot drop of hemiplegic person
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Walking speed,stride length
2.Center of gravity
3.Floor reaction force
4.Joint angle
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Device,equipment |
Interventions/Control_1
To train by using the device three times a week.
Interventions/Control_2
To perform regular physical therapy training for a week.
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Things that can stand alone at Brunstrom Stage III (Recovery degree of motor paralysis) or higher
2.Have sufficient joint mobility (5 degrees dorsiflexion to 30 degrees dorsiflexion)
3. Those without sense of loss
4. Mini Mental State Examination (dementia diagnostic test) More than 23 points
5. Frontal Assessment Battery (frontal lobe disorder screening test) More than 12 points
Key exclusion criteria
1. Uncontrolled heart failure
2. Acute myocardial infarction
3. Active myocarditis or pericarditis
4. Unstable angina
5. Acute systemic embolism or pulmonary embolism
6. Acute infection
7. Thrombotic phlebitis
8. Ventricular tachycardia or intractable ventricular arrhythmia
9. Severe ventricular outflow tract obstruction
Ten. Uncontrolled arterial hypertension or pulmonary hypertension
11. At the same time, if you are in the target of another intervention study (verified with your physical therapist)
12. Excessive contracture
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Iwata |
| Middle name | |
| Last name | Hiroyasu |
Organization
Waseda University
Division name
Faculty science and engineering
Zip code
162-0042
Address
27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P
TEL
03-3203-4427
jubi@waseda.jp
Public contact
Name of contact person
| 1st name | Iwata |
| Middle name | |
| Last name | Hiroyasu |
Organization
Waseda University
Division name
Faculty science and engineering
Zip code
162-0042
Address
27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P
TEL
03-3203-4427
Homepage URL
jubi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Akiba Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University
Address
1-104, Totsukamachi, Shinjuku-ku, Tokyo Building 9, 2F
Tel
03-5272-1639
rinri@list.waseda.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
秋葉病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 22 | 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
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2019 | Year | 04 | Month | 22 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041669
