UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056146 |
|---|---|
| Receipt number | R000064151 |
| Scientific Title | Effects of Different Conditions in Foot Somatosensory Training on Plantar Somatosensory Function |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2024/11/13 15:50:27 |
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Basic information
Public title
Effects of Different Conditions in Foot Somatosensory Training on Plantar Somatosensory Function
Acronym
Effects of Different Conditions in Foot Somatosensory Training on Plantar Somatosensory Function
Scientific Title
Effects of Different Conditions in Foot Somatosensory Training on Plantar Somatosensory Function
Scientific Title:Acronym
Effects of Different Conditions in Foot Somatosensory Training on Plantar Somatosensory Function
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Declines in foot somatosensory function can negatively impact balance and daily activities, particularly in older adults and individuals with neurological conditions. Despite this, effective physical therapeutic interventions to improve foot sensory function are limited. This study assessed the effects of targeted foot somatosensory training on plantar sensory function in healthy young adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tactile pressure sensitivity and two-point discrimination of the plantar surface
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants in the discrimination group performed a task involving barefoot placement of the sole on a multi-axial instability board while seated with eyes closed. A weight was randomly placed at one of four locations - front, back, left, or right - on the instability board, and the participants were asked to identify the weight's position. The foot used for the task was defined as the dominant leg, was identified as the leg used to kick the ball.
For the first task, a 100 g weight was used, and participants were required to correctly identify its position in 10 consecutive trials to proceed to the second task, which involved a 75 g weight. If successful, they moved on to the third task using a 50 g weight. The task was concluded if 10 consecutive correct responses were achieved in the final stage.
Feedback during the task was given as follows: correct answers received verbal confirmation, while incorrect answers prompted the participant to pause the task and open their eyes to visually confirm the weight's position.
Interventions/Control_2
The attention group followed the same posture and experimental setup as the discrimination group but focused on timing rather than position. Participants were tasked with identifying the time when the weight was placed on the instability board and had to respond within approximately one second of placing the weight. Responses that were either too quick or slow were deemed incorrect.
For the first task, a 100 g weight was used, and participants needed to achieve 10 consecutive correct responses to advance to the second task using a 75 g weight. If participants completed 10 consecutive correct responses in the second task, they progressed to the third task with a 50 g weight. The task was concluded once the participants correctly responded in ten consecutive trials in the final stage.
Feedback during the task was provided as follows: if the response was correct, verbal confirmation was provided, and the task continued. For incorrect responses, the task was paused, and the participants received feedback on the accuracy of their timing judgment.
Interventions/Control_3
Control group participants maintained the same posture and experimental setup as other groups but watched a medical drama for 20 minutes. To ensure that the video content was unfamiliar, each participant confirmed that this was their first viewing of the video. Afterwards, they verbally recalled details about the characters and plot to confirm that they had actively engaged with the video.
To standardize somatosensory input across the groups, a weight (one of the three types) was randomly placed on the multi-axial instability board every 30 seconds throughout the video session. This ensured that the foot sensory inputs of the control group matched those of the discrimination and attention groups.
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
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study included young healthy adults who provided informed consent.
Key exclusion criteria
Exclusion criteria included any overt orthopedic disorders of the foot, history of neurological disorders, sensory impairment in the foot area, or foot pain.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | junichi |
| Middle name | |
| Last name | suganuma |
Organization
Chubu Gakuin University
Division name
Faculty of Nursing and Rehabilitation Department, Physical Therapy
Zip code
501-3993
Address
2-1 Kirigaoka, Seki City, Gifu Prefecture
TEL
08052907737
junichi1393@gmail.com
Public contact
Name of contact person
| 1st name | junichi |
| Middle name | |
| Last name | suganuma |
Organization
Chubu Gakuin University
Division name
Faculty of Nursing and Rehabilitation Department, Physical Therapy
Zip code
501-3993
Address
2-1 Kirigaoka, Seki City, Gifu Prefecture
TEL
08052907737
Homepage URL
junichi1393@gmail.com
Sponsor or person
Institute
Faculty of Nursing and Rehabilitation Department, Physical Therapy, Chubu Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Nursing and Rehabilitation Department, Physical Therapy, Chubu Gakuin 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
Chubu Gakuin University
Address
2-1 Kirigaoka, Seki City, Gifu Prefecture
Tel
08052907737
suganuma-junichi@chubu-gu.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 | 13 | 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
33
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
Main results already published
Date of protocol fixation
| 2024 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 06 | 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 | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064151
