UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055976 |
|---|---|
| Receipt number | R000063974 |
| Scientific Title | Effects of the number of repetitions of voice gait instructions on gait change in daily life using gait measurement equipment. |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/10/29 11:35:27 |
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Basic information
Public title
Effects of the number of repetitions of voice-guided gait instructions on gait change in daily life using gait measurement equipment.
Acronym
The effect of the number of repetitions of voice-based walking instructions on gait.
Scientific Title
Effects of the number of repetitions of voice gait instructions on gait change in daily life using gait measurement equipment.
Scientific Title:Acronym
The effect of the number of repetitions of voice gait instructions using gait measurement equipment on daily walking.
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the number of repetitions of the walking instructions given to the user during unsupervised walking.
Basic objectives2
Others
Basic objectives -Others
To examine the effect of the number of repetitions of spoken gait instructions on changes in daily walking
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in mean cadence between the group with walking instructions every morning and the group with walking instructions for only one day
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
On the first day, the participants will be measured without being aware of their walking style as a normal measurement. On the second day of the measurement period, they will receive one audio walking instruction. The same walking instructions will then be given on days 3 to 5 for the group that receives daily instructions.
Interventions/Control_2
On the first day, the participants will be measured without being aware of their walking style as a normal measurement. On the second day of the measurement period, they will receive one audio walking instruction. Thereafter, for the group that receives walking instructions for only one day, walking instructions will not be given on days 3 through 5.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Young group: Men and women between 18 and 34 years old who belong to Kyoto University and can walk for more than 30 minutes.
Older group: Men and women over 65 years old who live in the area and can walk for more than 30 minutes.
Key exclusion criteria
-Those who experience pain in the lower limbs when walking
-Those who have difficulty understanding or consenting to the research explanation
-Those who have a disease or disability that affects walking, have obvious claudication, or use a walking aid such as a cane
-Those who have difficulty measuring walking with shoes on.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Aoyama |
Organization
Kyoto University, Graduate School of Medicine, Department of Human Health Sciences.
Division name
Innovative Rehabilitation Science Laboratory, Department of Advanced Physical Therapy, Course of Advanced Rehabilitation Science, Analysis of Motor Function
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-3952
aoyama.tomoki.4e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoki |
| Middle name | |
| Last name | Aoyama |
Organization
Kyoto University, Graduate School of Medicine, Department of Human Health Sciences.
Division name
Course in Advanced Rehabilitation Science, Department of Advanced Physical Therapy
Zip code
606-8507
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
TEL
075-751-3952
Homepage URL
aoyama.tomoki.4e@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University, Graduate School of Medicine, Department of Human Health Sciences.
Institute
Department
Personal name
Funding Source
Organization
Adjust it yourself.
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 01 | 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 | 10 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 10 | Month | 29 | Day |
Last modified on
| 2024 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063974
