UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030097 |
|---|---|
| Receipt number | R000034362 |
| Scientific Title | The study on the effect of functional insole on gait |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2023/05/30 09:54:38 |
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Basic information
Public title
The study on the effect of functional insole on gait
Acronym
The effect of functional insole
Scientific Title
The study on the effect of functional insole on gait
Scientific Title:Acronym
The effect of functional insole
Region
| Japan |
Condition
Condition
normal subject
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A lot of insoles have released from many manufacturers, but the effect has not been objectively evaluated. In this research, we aimed to quantitatively evaluate the effect of insole for healthy subjects using a 3D motion analysis device and a floor reaction force meter.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The parameters of gait (walking speed, stride, step and posture) and floor reaction force data before and after using functional insole.
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
functional insole
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy subject
Key exclusion criteria
Subject who cannot walk independently without an assistive device, such as a cane or walker, and has other neuromuscular, cardiopulmonary or osteoarticular disorders.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Wada |
Organization
Gunma University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
371-8511
Address
3-39-15, Showamachi, Maebashi, Gunma, Japan
TEL
027-234-7882
nwada@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Tazawa |
Organization
Gunma University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
371-8511
Address
3-39-15, Showamachi, Maebashi, Gunma, Japan
TEL
027-234-7882
Homepage URL
mastaz1@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
BMZ.inc
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
Clinical Investigation and Research Unit
Address
3-39-15, Showamachi, Maebashi, Gunma, Japan
Tel
027-220-8740
irb-jimukk-ciru@ml.gunma-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
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/kmj/73/1/73_9/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/kmj/73/1/73_9/_article/-char/ja
Number of participants that the trial has enrolled
18
Results
The effect of insoles supporting the cuboid and anterior calcaneus in 18 healthy subjects was investigated and found to reduce ankle joint power without reducing walking ability. It is thought that the use of carbon fibre insoles reduced ankle joint power without reducing walking ability and equalised power between the left and right sides. This was thought to reduce muscle strain on the unilateral lower limb.
Results date posted
| 2023 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
18 healthy males and females
Participant flow
We recruit healthy subjects between 20 and 60 years of age. (Recruitment notices will be posted at universities and rehabilitation department outpatient clinics. Care will be taken to ensure that there is no coercion to participate in the study).
Eligibility criteria are healthy subjects aged between 20 and 60 years.
Exclusion criteria are those who need a walking aid such as a cane, or have a neuromuscular, cardiac or orthopaedic disease that affects walking.
Adverse events
none
Outcome measures
Walking speed
Cadence (steps per minute)
Step length (stride length)
Stride length (overlapping stride distance)
Hip joint moment
Hip power
Ankle moment
Ankle power
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2020 | 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
| 2017 | Year | 11 | Month | 24 | Day |
Last modified on
| 2023 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034362
