UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054407 |
|---|---|
| Receipt number | R000062123 |
| Scientific Title | Development of an abnormal walking detection system for people with stroke hemiplegia |
| Date of disclosure of the study information | 2024/06/15 |
| Last modified on | 2024/05/16 07:12:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of an abnormal walking detection system for people with stroke hemiplegia
Acronym
Development of an abnormal walking detection system for people with stroke hemiplegia
Scientific Title
Development of an abnormal walking detection system for people with stroke hemiplegia
Scientific Title:Acronym
Development of an abnormal walking detection system for people with stroke hemiplegia
Region
| Japan |
Condition
Condition
Healthy people and stroke hemiplegia
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the following within the research period, using the healthy walking database provided for research, targeting healthy people and stroke hemiplegia.
1) Develop an index (GDI: Gait_Degree_Index) that can relatively evaluate the angle of "hip joint", "knee joint", "foot joint" and "lower leg" at the characteristic point of each walking cycle.
2) Verify the reliability and validity of GDI among healthy people.
3) Verify the reliability and validity of GDI in stroke.
4) Build a system that can easily measure and calculate GDI in clinical practice.
Using GDI, quantitatively evaluate the walking pattern of hemiplegic people and establish a way to objectively detect walking abnormalities. This makes it easier to grasp the problems of the subject, makes it possible to plan an accurate and individualized treatment plan, and it is possible to contribute to the improvement of the subject's walking.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Walking data (walking speed, time distance factor, joint angle, proportion of walking cycle, mechanical data, kinetic dynamic data)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
VICON's three-dimensional motion analysis system was used for measurement. The measurement time is expected to take about 2 hours. In addition, in order to easily calculate GDI clinically, we plan to use "Open cap" developed by Stanford University (https://www.opencap.ai). By using this, you can easily measure the joint angle and walking speed in the clinical field without using a large-scale device, and it will be possible to calculate GDI. However, since the accuracy of the Open cap has not been verified, three-dimensional motion analysis and Open cap are measured at the same time, and the walking speed and joint angle are extracted respectively to verify the accuracy of the Open cap.
Interventions/Control_2
VICON's three-dimensional motion analysis system was used for measurement. The measurement time is expected to take about 2 hours. In addition, in order to easily calculate GDI clinically, we plan to use "Open cap" developed by Stanford University (https://www.opencap.ai). By using this, you can easily measure the joint angle and walking speed in the clinical field without using a large-scale device, and it will be possible to calculate GDI. However, since the accuracy of the Open cap has not been verified, three-dimensional motion analysis and Open cap are measured at the same time, and the walking speed and joint angle are extracted respectively to verify the accuracy of the Open cap.
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) GDI calculation
Utilize all the data for 298 people held by the Walking Database Research Subcommittee of the Biomechanistry Society. The calculation basis is that the amount of information for 298 people is sufficient as the number of samples in which the extracted data can be normally distributed.
(2) Three-dimensional motion analysis and Open cap measurement at Hokkaido University of Science
We believe that the number of people in three-dimensional motion analysis and Open cap measurement in healthy and stroke hemiplegia is about N=5 respectively. This is intended to verify whether the measurement data in the Open cap is different from the data in the three-dimensional motion analysis device, and we believe that it is sufficient for accuracy verification. The research subjects will be publicly recruited, and they will be posted on the website as an information disclosure document to Sapporo Aso Neurosurgery Hospital.
(3) Open cap measurement at Sapporo Aso Neurosurgery Hospital
I think that about N = 5 is also reasonable for measurement at Sapporo Aso Neurosurgery Hospital. As for the N number, the purpose is to verify whether it is possible to measure easily in clinical practice, and since the accuracy verification of the Open cap is carried out in advance by three-dimensional motion analysis and Open cap measurement at Hokkaido University of Science, the N number is reasonable. I'm thinking. The research subjects will be publicly recruited, and they will be posted on the website as an information disclosure document to Sapporo Aso Neurosurgery Hospital.
Key exclusion criteria
Those that do not have serious heart disease or internal disorders
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kon |
Organization
Hokkaido University of Science
Division name
Department of Prosthetics and Orthotics, Faculty of Health and Medical Sciences
Zip code
006-8585
Address
4-1, 15-chome, 7-jo, Maeda, Teine-ku, Sapporo
TEL
011-688-2240
kon@hus.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Mori |
Organization
Hokkaido University of Science
Division name
Entrance Examination and Regional Collaboration Department, Research Promotion Division
Zip code
006-8585
Address
4-1, 15-chome, 7-jo, Maeda, Teine-ku, Sapporo
TEL
011-681-2161
Homepage URL
kenkyu@hus.ac.jp
Sponsor or person
Institute
Sapporo Azabu Neurosurgery Hospital
Institute
Department
Personal name
Yoshihiro Mori
Funding Source
Organization
Hokkaido University of Science
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
Hokkaido University College Entrance Examination and Regional Collaboration Department Research Promotion Division
Address
4-1, 15-chome, 7-jo, Maeda, Teine-ku, Sapporo
Tel
011-688-2241
kenkyu@hus.ac.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
北海道
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | 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
| 2024 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 05 | Month | 16 | Day |
Last modified on
| 2024 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062123
