UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051062 |
|---|---|
| Receipt number | R000058224 |
| Scientific Title | An Assist Method for After-Surgery Orthopedic Patients using Perception Support to Prevent New Deformity on Knee Joint |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2023/05/15 15:12:44 |
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Basic information
Public title
Clinical evaluation of stimulus discrimination and gait improvement of perceptual co-sensory wear that shares foot pressure at the hip and back
Acronym
Clinical evaluation of stimulus discrimination and gait improvement of perceptual co-sensory wear that shares foot pressure at the hip and back
Scientific Title
An Assist Method for After-Surgery Orthopedic Patients using Perception Support to Prevent New Deformity on Knee Joint
Scientific Title:Acronym
An Assist Method for After-Surgery Orthopedic Patients using Perception Support to Prevent New Deformity on Knee Joint
Region
| Japan |
Condition
Condition
Knee asteoarthrithrtis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To propose a rehabilitation method for orthopedics patient aiming to prevent re-deformity in knee after surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plantar pressure (Pre-intervention, Post-intervention)
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
Gait rehabilitation while wearing the vibrating device
Objective: To train the subject to become accustomed to the position of his/her foot by telling him which part of the foot he/she should put pressure on through the vibration.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have requested to participate in training with a sensory-assistive orthosis and meet the following criteria
1. Lower limb Brunnstrom stage III to VI
2. Patients with no higher brain dysfunction
3. Patients whom the attending physician and physical therapist can judge that there is no problem in conducting the examination.
Able-bodied older adults who have requested to participate in training using a sensory assistive device.
Key exclusion criteria
1. uncontrolled heart failure
2. acute myocardial infarction
3. Active myocarditis or pericarditis
4. unstable angina pectoris
5. acute systemic embolism or pulmonary embolism
6. Acute infectious disease
Thrombophlebitis
Ventricular tachycardia or refractory ventricular arrhythmia
9. Severe ventricular outflow tract obstruction
Uncontrolled arterial or pulmonary hypertension
11. being a participant in another interventional study at the same time (to be confirmed verbally with the physiotherapist in charge).
Exclusion criteria are at the discretion of the physician in charge.
Target sample size
20
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
Room 603, Green Computing Systems Research Organization, Building 40, Waseda University, 27 Waseda-cho, Shinjuku-ku, Tokyo
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
Room 603, GCS, Building 40, Waseda University, 27 Waseda-cho, Shinjuku-ku, Tokyo
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
Saiwai Tsurumi Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Waseda University
Address
1-104 Totsuka-cho, Shinjyuku-ku, Tokyo 169-8050
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 | 05 | Month | 15 | 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 | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 06 | 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
| 2023 | Year | 05 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058224
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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