UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052059 |
|---|---|
| Receipt number | R000059418 |
| Scientific Title | Examining the effect of the amount of support on rehabilitation of stroke hemiplegic patients for lower limb movements. |
| Date of disclosure of the study information | 2023/09/03 |
| Last modified on | 2023/08/30 16:34:22 |
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Basic information
Public title
Examining the effect of the amount of support on rehabilitation of stroke hemiplegic patients for lower limb movements.
Acronym
Examining the effect of the amount of support on rehabilitation of stroke hemiplegic patients for lower limb movements.
Scientific Title
Examining the effect of the amount of support on rehabilitation of stroke hemiplegic patients for lower limb movements.
Scientific Title:Acronym
Examining the effect of the amount of support on rehabilitation of stroke hemiplegic patients for lower limb movements.
Region
| Japan |
Condition
Condition
stroke hemiplegic
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of whether the developed system can search for a critical point where spasticity does not occur during rehabilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical quantities of the lower limb (coordinates, forces), myopotentials, video
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Rehabilitation performed with VR and lower extremity devices for 15 minutes per day for one week
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
(1) Hemiplegic stroke patients
(2) Patients with no limitation in joint range of motion
(3) Patients in the hyperacute stage or later, more than 2 weeks after the onset of stroke
(4) Patients with no cognitive or cognitive impairment or higher brain dysfunction
Key exclusion criteria
(1) Uncontrolled heart failure
(2) Acute myocardial infarction
(3) Active myocarditis or pericarditis
(4) Unstable angina pectoris
(5) Acute progressive embolism or pulmonary embolism
(6) Acute infectious disease
(7) Thrombophlebitis
(8) Ventricular tachycardia or refractory ventricular arrhythmia
(9) Severe ventricular outflow tract obstruction
(10) Uncontrolled arterial or pulmonary hypertension
(11) If the subject is in another interventional study at the same time (confirm verbally with the therapist in charge)
(12) Inability to perform the tasks indicated in the study procedures (including breaks between tasks)
Exclusions will be made at the discretion of the treating physician.
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-machi, Shinjuku-ku, Tokyo 162-0042, Japan Green Computing Systems Research Organization 603 Prof. Iwata lab.
TEL
03-3203-4427
jubi@waeda.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-machi, Shinjuku-ku, Tokyo 162-0042, Japan Green Computing Systems Research Organization 60
TEL
03-3203-4427
Homepage URL
jubi@waeda.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
2F Building No. 9, 1-104 Totsukacho, Shinjuku-ku, Tokyo
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 03 | 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
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 08 | Month | 30 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059418
