UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051913 |
|---|---|
| Receipt number | R000059227 |
| Scientific Title | A study on changes associated with instructions for walking in daily life using a gait measuring device |
| Date of disclosure of the study information | 2023/08/15 |
| Last modified on | 2025/06/23 11:42:48 |
* 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
A study on changes associated with instructions for walking in daily life using a gait measuring device
Acronym
A study on changes associated with instructions for walking in daily life using a gait measuring device
Scientific Title
A study on changes associated with instructions for walking in daily life using a gait measuring device
Scientific Title:Acronym
A study on changes associated with instructions for walking in daily life using a gait measuring device
Region
| Japan |
Condition
Condition
Elderly people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effects of unsupervised walking instructions for older and younger adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in average walking speed before and after walking instructions.
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
On the first day of daily gait measurement, gait without walking instructions will be measured for one day. On the second day of measurement, walking instructions will be given once using images, and the effects of the instruction will be measured for three days.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women affiliated with Kyoto University who are able to walk and are between the ages of 18 and 34.
Community dwelling men and women aged 65 and over who are able to walk
Key exclusion criteria
Young people group
People who feel pain in their lower limbs when walking
Persons who have difficulty understanding or consenting to research explanations
Those who have a disease or disability that affects walking, have obvious lameness, or use a walking aid such as a cane.
Elderly group
People who have difficulty measuring walking while wearing shoes
Persons who have difficulty understanding or consenting to research explanations
Persons with severe lameness that cannot be measured with A-RROWG
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Aoyama |
Organization
Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name
Course of Advanced Rehabilitation Sciences, Advanced Physical Therapy, Motor Function Analysis
Zip code
606-8507
Address
53 Shogoin Kawaramachi, Sakyo Ward, Kyoto City, JAPAN
TEL
075-751-3952
aoyama.tomoki.4e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Suzuki |
Organization
Human Health Sciences, Graduate School of Medicine, Kyoto University
Division name
Course of Advanced Rehabilitation Sciences, Advanced Physical Therapy, Motor Function Analysis
Zip code
606-8507
Address
53 Shogoin Kawaramachi, Sakyo Ward, Kyoto City, JAPAN
TEL
090-3729-7058
Homepage URL
bamboos144@gmail.com
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Aoyana Tomoki
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
NEC Corporation
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
| 2023 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059227
Publication of results
Unpublished
Result
URL related to results and publications
Under submission
Number of participants that the trial has enrolled
58
Results
In the group that exhibited propulsion-enhancing changes, younger adults increased their maximum plantar flexion angle and walking speed within 24 h of instruction. Walking speed increased among older adults in the same group; however, no significant changes were observed in the maximum plantar flexion angle. Conversely, in the group emphasizing weight support, older adults experienced significant reduction in walking speed and stride length. None of the observed effects persisted beyond 24 h in any group.
Results date posted
| 2025 | Year | 06 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty individuals were included in the older group (mean age: 75.6 (SD = 6.9) years), comprising 3 males and 27 females. One participant used a walker, and the other used a cane.
Twenty-eight individuals were included in the younger group (mean age: 24.1 (SD = 2.0) years), comprising 14 males and 14 females.
Participant flow
All the participants completed the measurements without dropping out. Three older participants and one young participant were excluded from subsequent analysis because they could not confirm the walking instructions properly. Additionally, some data were missing because of problems with the measuring equipment or participants not walking long enough to obtain the data. The number of missing data points due to equipment issues, combining older and younger participants, was 0 at BL, 3 at PO24, 7 at PO48, and 13 at PO72. The missing data due to participants not walking were 0 at BL, 1 at PO24, 2 at PO48, and 4 at PO72. Participants with missing BL or post-instruction data were excluded. For missing data in the middle of the measurement period, data from the period in which measurements were possible were used. As a result, the older group included data from 25 participants at BL, 25 at PO24, 21 at PO48, and 16 at PO72, whereas the younger group included data from 27 participants at BL, 25 at PO24, 24 at PO48, and 21 at PO72.
Adverse events
No adverse events occurred.
Outcome measures
In Older E, walking speed decreased from 3.81 km/h (SD = 0.17) at BL to 3.42 km/h (SD = 0.17) at PO24 (p < 0.01), and stride length decreased from 108 cm (SD = 4) to 100 cm (SD = 4) (p < 0.01). Maximum (peak) plantar flexion angle declined from 63.3 deg (SD = 1.3) to 59.4 deg (SD = 1.3) (p < 0.01), while pushing time increased from 0.21 s (SD = 0.01) to 0.23 s (SD = 0.01) (p < 0.01).
In Older I, walking speed increased from 3.77 km/h (SD = 0.21) at BL to 3.91 km/h (SD = 0.23) at PO24 (p < 0.05), while pushing time decreased from 0.22 s (SD = 0.01) to 0.20 s (SD = 0.01) (p < 0.01).
In Young I, walking speed increased from 4.35 km/h (SD = 0.11) to 4.62 km/h (SD = 0.11) (p < 0.01), and stride length increased from 129 cm (SD = 3) to 134 cm (SD = 3) (p < 0.05). Maximum (peak) plantar flexion angle also increased from 72.7 deg (SD = 1.6) to 76.9 deg (SD = 2.0) (p < 0.01), while pushing time decreased from 0.23 s (SD = 0.01) to 0.21 s (SD = 0.01) (p < 0.01).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059227
