UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046859 |
|---|---|
| Receipt number | R000053462 |
| Scientific Title | Examination based on kinematic gait evaluation of changes leading to support for older adult independence by using non-powered gait assist equipment |
| Date of disclosure of the study information | 2022/02/08 |
| Last modified on | 2025/05/14 10:07:39 |
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Basic information
Public title
Examination based on kinematic gait evaluation of gait changes in the older adult using non-powered gait assist devices
Acronym
Kinematic gait evaluation of non-powered gait assist device
Scientific Title
Examination based on kinematic gait evaluation of changes leading to support for older adult independence by using non-powered gait assist equipment
Scientific Title:Acronym
Kinematic gait evaluation of non-powered gait assist device
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining changes in gait due to wearing a non-powered gait assist device
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in steady walking speed before and after wearing the device (before wearing, immediately after wearing, and after wearing and practicing)
Key secondary outcomes
Stride length, pace, foot pressure center / center of gravity trajectory, hip / knee / ankle joint angle range of motion, rectus femoris / biceps femoris / tibialis anterior / gastrocnemius / soleus muscle activity on both sides
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1 minute walking on GRAIL immediately after wearing the non-powered walking assist device/ 1 minute walking on GRAIL before wearing the device
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
20 healthy young people (20-40 years old) and 20 elderly people (65 years old and over)
Key exclusion criteria
Those who have obvious gait disturbance due to locomotor disorders such as lower limbs or pain, those who correspond to physical frailty of 3 points or more in J-CHS (Japanese version of frailty evaluation standard), those who have been diagnosed with dementia.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Izumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center for Geriatrics and Gerontology
Division name
Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
ik7710@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Kato |
Organization
National Center for Geriatrics and Gerontology
Division name
Laboratory for Clinical Evaluation with Robotics, Assistive Robot Center
Zip code
4748511
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
TEL
0562462311
Homepage URL
kk0724@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology, Ethics and Interest Conflict Committee
Address
7-430, Morioka, Obu, Aichi 474-8511, JAPAN
Tel
0562462311
ik7710@ncgg.go.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
国立長寿医療研究センター（愛知県）
National Center for Geriatrics and Gerontology (Aichi)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 08 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053462
