UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044709 |
|---|---|
| Receipt number | R000051050 |
| Scientific Title | Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls |
| Date of disclosure of the study information | 2021/06/29 |
| Last modified on | 2025/01/06 21:27:57 |
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Basic information
Public title
Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls
Acronym
Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls
Scientific Title
Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls
Scientific Title:Acronym
Development of a new screening test of measure lower extremity agility to attempt to regain standing balance to avoid falls
Region
| Japan |
Condition
Condition
Health adults and elderly people requiring support
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development and validation of a new screening test of measure lower extremity agility using a single step forward to attempt to regain standing balance to avoid falls
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the time required to step
Key secondary outcomes
Open-Close Stepping Test
Timed Up & Go Test
Maximum Walking Speed
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Health adults aged 20 over
Elderly people requiring support
Person who give consent to participate in the study
Key exclusion criteria
Persons who have a history of neuromuscular disorder, orthopedic diseases, dementia and requiring long-term care
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | MASAYA |
| Middle name | |
| Last name | TAKI |
Organization
Japan Community Health care Organization Chukyo Hospital
Division name
Rehabilitation center
Zip code
457-8510
Address
1-1-10 Sanjo,Minami-ku,Nagoya,Aichi,Japan
TEL
052-691-7151
taki-masaya@chukyo.jcho.go.jp
Public contact
Name of contact person
| 1st name | MASAYA |
| Middle name | |
| Last name | TAKI |
Organization
Japan Community Health care Organization Chukyo Hospital
Division name
Rehabilitation center
Zip code
457-8510
Address
1-1-10 Sanjo,Minami-ku,Nagoya,Aichi,Japan
TEL
052-691-7151
Homepage URL
taki-masaya@chukyo.jcho.go.jp
Sponsor or person
Institute
Japan Community Health care Organization Chukyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Community Health care Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Community Health care Organization
Address
3-22-12 Takanawa,Minato-ku,Tokyo,Japan
Tel
03-5791-8220
iryoka@jcho.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 29 | 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
61
Results
A significant correlation was observed between step time and TUG (r = 0.52) and between step time and 10mMWS (r=0.31). The proposed screening test, the Five Forward Stepping test (FFStest), showed significant correlations with reaction time (r = 0.55), step time (r = 0.60), TUG (r = 0.57), 10mMWS (r = 0.31), and the open-close stepping test (r = -0.47). The FFStest was significantly slower in participants in their 50s compared to those in their 20s (p < 0.05).
Results date posted
| 2025 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adults aged 20 to 70 years were included, while individuals with orthopedic disorders, central nervous system disorders, difficulty understanding the test procedures, or inability to complete the experiment were excluded.There were 29 men and 32 women. The number of participants in each age group was as follows: 27 in their 20s, 12 in their 30s, 6 in their 40s, 7 in their 50s, and 9 aged 60 or older.
Participant flow
Adverse events
None
Outcome measures
Using a three dimensional motion analysis system and foot switches, kinematic analysis was performed to measure reaction time and step time. Additionally, a novel test, the Five Forward Stepping test, was developed. To evaluate the criterion-related validity of the Five Forward Stepping test, the Open-Close Stepping Test, Timed Up & Go Test, and 10meter maximum walking speed were measured.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 06 | Month | 29 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051050
