UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058599 |
|---|---|
| Receipt number | R000067002 |
| Scientific Title | Effects of Insoles Designed Based on Physical Therapist Assessment on Lower Limb and Trunk Pain and Functional Impairment |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/07/25 16:23:37 |
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Basic information
Public title
A Study to Examine the Effects of Insoles Designed Based on Physical Therapist Assessment
Acronym
PT Insole Study
Scientific Title
Effects of Insoles Designed Based on Physical Therapist Assessment on Lower Limb and Trunk Pain and Functional Impairment
Scientific Title:Acronym
Trial of Insoles Based on PT Assessment
Region
| Japan |
Condition
Condition
Individuals with musculoskeletal disorders affecting the lower limb and trunk
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of custom-made insoles designed based on physical therapist assessment on lower limb and trunk function and pain in users.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain after 3 months
Key secondary outcomes
Physical dysfunction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who have had insoles made based on the evaluation of a physical therapist
Key exclusion criteria
Those who cannot walk independently
Those who are judged to have a neurological disorder or other condition that affects their walking more than the effect of insoles.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
d.uritani@kio.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio Univeristy
Division name
Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
d.uritani@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kobe Sougu Seisakusyo (Kobe Orthotics Manufacturing Co., Ltd.)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel
0745541601
soumu@kio.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 | 09 | 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
| 2025 | Year | 07 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 07 | Month | 25 | Day |
Last modified on
| 2025 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067002
