UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041068 |
|---|---|
| Receipt number | R000046904 |
| Scientific Title | Effect of stroke patients with hemiplegia with the gait rehabilitation training using the biofeedback device to share paralyzed-side foot contact of the patient on the waist and back |
| Date of disclosure of the study information | 2020/07/10 |
| Last modified on | 2020/07/10 19:32:24 |
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Basic information
Public title
Effect of stroke patients with hemiplegia with the gait rehabilitation training using the biofeedback device to share paralyzed-side foot contact of the patient on the waist and back
Acronym
Effect of stroke patients with hemiplegia with the gait rehabilitation training using the biofeedback device
Scientific Title
Effect of stroke patients with hemiplegia with the gait rehabilitation training using the biofeedback device to share paralyzed-side foot contact of the patient on the waist and back
Scientific Title:Acronym
Effect of stroke patients with hemiplegia with the gait rehabilitation training using the biofeedback device
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We test the effect of the biofeedback device on stroke patients with hemiplegia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait speed(Immediately after intervention)
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Usual gait rehabilitation training(Use Period:None)
Interventions/Control_2
Gait rehabilitation training patient's using the biofeedback device (Use Period: 1 day(15 min))
Interventions/Control_3
Gait rehabilitation training patient's and therapist's using the biofeedback device(Use Period: 1 day(15 min))
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient who agree to the clinical test and meet the following conditions.
1. Patient's recovery stage is Brunnstrom stage 3/4/5
2. The patient has no higher brain dysfunction.
3. Primary doctor and therapist allowed patients to the gait training.
Key exclusion criteria
The patient has the following serious condition
1.Uncontrollable heart failure
2.Acute myocardial infarction
3.Myocarditis,pericarditis
4.Angina pectoris
5.Acute embolism, pulmonary embolism
6.Acute infection
7.Thrombophlebitis
8.Ventricular tachycardia, ventricular arrhythmia
9.Uncontrollable arterial hypertension, pulmonary hypertension
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iwata |
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 Prof. Iwata Lab.
TEL
03-3203-4427
jubi@waseda.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iwata |
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
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University Ethics Review Committee
Address
2nd floor, No. 9 Bldg.1-104 Totsuka -cho, Shinjuku-ku, Tokyo 162-0044, Japan
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
総合東京病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 10 | 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 | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 07 | Month | 10 | Day |
Last modified on
| 2020 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046904
