UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057507 |
|---|---|
| Receipt number | R000065708 |
| Scientific Title | Insole intervention study on center of pressure and plantar loading during standing in community-dwelling older adults |
| Date of disclosure of the study information | 2025/04/18 |
| Last modified on | 2026/04/05 12:32:43 |
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Basic information
Public title
Insole intervention study on standing balance in community-dwelling older adults
Acronym
Insole intervention tests
Scientific Title
Insole intervention study on center of pressure and plantar loading during standing in community-dwelling older adults
Scientific Title:Acronym
Insole intervention study on postural sway and plantar loading
Region
| Japan |
Condition
Condition
Community dwelling elderly people
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the effects of four different insole types on body sway and plantar loading during static standing in elderly subjects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjects will receive four different insole interventions on the same day. The plantar surface of the foot will be divided into 7 compartments, and plantar pressure in each compartment will be measured during the insole intervention.
Key secondary outcomes
Subjects will be measured the center of pressure at the time of insole intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The standing condition is eyes closed, upper limbs contralateral, foot angle 14 degree, and distance between heels 17 cm. The static standing posture is performed for 30 seconds, three times for each insole. A 2-minute rest is allowed between sessions.
Interventions/Control_2
The insoles will include a textured insole, which stimulates the plantar surface, and a smooth insole, which does not provide stimulation.
The insole conditions will be as follows:
Control group: A smooth insole inserted across the entire plantar surface.
Forefoot textured insole (TI) group: A textured insole inserted in the forefoot area.
Rearfoot TI group: A textured insole inserted in the rearfoot area.
Full TI group: A textured insole inserted across the entire plantar surface.
To compensate for differences in insole height, the forefoot TI group and rearfoot TI group will have smooth insoles inserted in areas where the textured insole is not applied.
Interventions/Control_3
The textured insole and smooth insole will have a thickness of 3 mm and will be made of ethylene-vinyl acetate (EVA) copolymer.
The textured insole will have protrusions with the following specifications:
Height: 1.5 mm
Diameter: 6 mm
Distance between protrusions: 5 mm
Interventions/Control_4
Four groups
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants will be community-dwelling older adults of both genders who have given their consent after receiving an explanation of the purpose and methods of the study both orally and in writing.
Key exclusion criteria
The exclusion criteria for participants are as follows:
Individuals who cannot maintain an eyes-closed standing position for more than 30 seconds without assistive devices.
Individuals with a history of neuromuscular diseases.
Individuals with a history of lower limb surgery.
Individuals with a history of vestibular dysfunction.
Individuals with plantar sensory impairment.
Individuals with cognitive decline.
Individuals with hallux valgus.
Plantar sensory impairment will be defined as the inability to perceive the Semmes-Weinstein Monofilament applied to the plantar surface.
Cognitive decline will be defined as a Mini-Mental State Examination (MMSE) score of less than 23.
Hallux valgus will be diagnosed if the hallux valgus angle, measured with a goniometer, is 20 degree or greater.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Takata |
Organization
Hokkaido Bunkyo University
Division name
Graduate School of Rehabilitation Sciences
Zip code
061-1449
Address
5-196-1 Koganechuo, Eniwa, Hokkaido 061-1449, Japan
TEL
0123340109
takata@do-bunkyodai.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Takata |
Organization
Hokkaido Bunkyo University
Division name
Graduate School of Rehabilitation Sciences
Zip code
061-1449
Address
5-196-1 Koganechuo, Eniwa, Hokkaido 061-1449, Japan
TEL
0123340109
Homepage URL
takata@do-bunkyodai.ac.jp
Sponsor or person
Institute
Hokkaido Bunkyo University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido Bunkyo University
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 Bunkyo University
Address
5-196-1 Koganechuo, Eniwa, Hokkaido 061-1449, Japan
Tel
0123340109
takata@do-bunkyodai.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
| 2025 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
https://data.mendeley.com/datasets/3cwjn6y8x9/5
Publication of results
Published
Result
URL related to results and publications
https://data.mendeley.com/datasets/3cwjn6y8x9/5
Number of participants that the trial has enrolled
43
Results
This study investigated whether forefoot- or rearfoot-textured insoles (hereafter referred to as TI; conditions: control, forefoot TI, rearfoot TI, and full TI) influence postural sway and plantar pressure during quiet standing in older adults.
Regarding plantar pressure, multiple comparisons revealed that the forefoot TI condition showed significantly lower toe pressure and significantly higher lateral forefoot pressure compared with the control condition.
Results date posted
| 2026 | Year | 04 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Community-dwelling older adults aged 65 years or older residing in Kitahiroshima City or Eniwa City, Hokkaido, Japan.
Participant flow
A total of 82 participants were assessed for eligibility. Of these, 39 participants were excluded.
Finally, 43 participants were enrolled in the study. All participants completed the measurements and were included in the analysis.
Adverse events
No adverse events were observed during the study.
Outcome measures
COP rectangular area, anteroposterior (AP) maximum range, AP velocity, AP COP position, and plantar pressure distribution.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 04 | Month | 04 | Day |
Last modified on
| 2026 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065708
