UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054512 |
|---|---|
| Receipt number | R000062248 |
| Scientific Title | Effect of arch pad insertion on cross-step Motion of people with decreased medial longitudinal arch |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/05/31 09:39:48 |
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Basic information
Public title
Effect of arch pad insertion on cross-step Motion of people with decreased medial longitudinal arch
Acronym
Effect of arch pad insertion on cross-step Motion of people with decreased medial longitudinal arch
Scientific Title
Effect of arch pad insertion on cross-step Motion of people with decreased medial longitudinal arch
Scientific Title:Acronym
Effect of arch pad insertion on cross-step Motion of people with decreased medial longitudinal arch
Region
| Japan |
Condition
Condition
youth people(Male only)
elderly people(Male only)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(1) To verify whether the insertion of an arch pad that assists the medial longitudinal arch can prevent the medial longitudinal arch from decreasing during cross-stepping movements for young people whose medial longitudinal arch is decreased due to loading. In addition, to verify whether the commonly used medial longitudinal arch pad or a pad that assists the transverse arch in addition to the medial longitudinal arch is more effective.
(2) To verify whether the insertion of arch pads in elderly patients can inhibit the reduction of the medial longitudinal arch during cross-stepping movements. Also, to verify whether the dynamic stability index (Extrapolated center of mass:Xcom) improves if the medial longitudinal arch reduction can be suppressed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Common to (1) and (2)
Amount of navicular bone reduction during movement
Lateral Xcom
Key secondary outcomes
Common to (1) and (2)
Center of Pressure (COP) position of the supporting leg just before contralateral lower limb ground contact
Angle of inversion and eversion forefoot relative to tibia
Angle of inversion and eversion hindfoot relative to tibia
Tibial rotation angle
Angular velocity and anterior tibial tilt
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
| Device,equipment |
Interventions/Control_1
(1) Two types of arch pads are inserted for young people. Arch pads should be inserted only at the time of measurement on the day (the insertion time of each arch pad is less than 15 minutes).
(2) For the elderly, use only the arch pad that was more effective in (1). Arch pads should be inserted only at the time of measurement on the day (the insertion time of each arch pad is 30 minutes or less).
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
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
(1)
Male youth aged 20~35 years old
Navicular Drop Test(ND value) is 9 mm or more
Consent to participate in research can be obtained in writing from the person in question.
Able to walk independently without using assistive devices
Able to understand research content and operations
No medical conditions that pose a risk of injury or impairment of health (e.g., nervous system, cardiovascular system, metabolic disorders, etc.)
(2)
Age 65~75 years old, male elderly
Consent to participate in research can be obtained in writing from the person in question.
Able to understand research content and operations
Able to walk independently without using assistive devices
No medical conditions that pose a risk of injury or impairment of health (e.g., nervous system, cardiovascular system, metabolic disorders, etc.)
Key exclusion criteria
(1)
Have a history of orthopedic surgery on the lower limbs and trunk
There is paralysis or paresthesia due to central nervous system disease
There is pain in the lower limbs and trunk in a stationary standing position or optimal walking.
If pain occurs due to the insertion of the arch pad
(2)
Have a history of orthopedic surgery on the lower limbs and trunk
There is paralysis or paresthesia due to central nervous system disease
You have lower limb or trunk pain that prevents you from cross-stepping.
If pain occurs due to the insertion of the arch pad
When practicing the measurement motion, if you are unable to perform the specified motion adequately
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Sumiko |
| Middle name | |
| Last name | Yamamoto |
Organization
International University of Health and Welfare Graduate School
Division name
Department of assistive technological science
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
03-5574-3874
sumiko-y@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Miyuki |
| Middle name | |
| Last name | Watanabe |
Organization
International University of Health and Welfare Graduate School
Division name
Department of assistive technological science
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
090-5743-9770
Homepage URL
23s3063@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Graduate School
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare Graduate School
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
International University of Health and Welfare Graduate School
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3874
akasaka-nyushi@iuhw.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 | 06 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062248
