UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057080 |
|---|---|
| Receipt number | R000062402 |
| Scientific Title | Effects of insoles on chronic ankle instability. |
| Date of disclosure of the study information | 2025/02/19 |
| Last modified on | 2025/02/19 15:05:40 |
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Basic information
Public title
Effects of insoles on chronic ankle instability.
Acronym
Effects of insoles on chronic ankle instability.
Scientific Title
Effects of insoles on chronic ankle instability.
Scientific Title:Acronym
Effects of insoles on chronic ankle instability.
Region
| Japan |
Condition
Condition
Chronic Ankle Instablity
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of two types of footwear on chronic ankle instability, the Y-Balance Test and instability during walking, using an insole of the thickness generally used inside the sole of a shoe (Flat Sole: FS) and a moulded device made of polypropylene and moulded from a slightly rigid foot mould (Foot Orthosis: FO). The effect on Y-Balance Test and instability during walking is verified using two types of foot orthosis (FO). The aim is also to perform a three-dimensional movement analysis during each task movement and to study the differences in kinematics and kinematic strategies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reaching distance of the lower limb by performing the Y-Balance Test.
Key secondary outcomes
Foot and ankle Measure (FAAM), Fear avoidance beliefs questionnaire (FABQ), kinematics and kinematic parameters of the lower limb and foot using a three-dimensional movement analyser.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Midfoot to hindfoot heel cup made of polypropylene [ PP], 2 cm deep, intended to prevent excessive forefoot motion with regard to inward and outward rotation of the hindfoot and rotation of the midfoot.
Interventions/Control_2
Insoles made of ethylene vinyl acetate copolymer [EVA] with a thickness of 3 mm, similar to the insoles included in common shoes.
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
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Women aged 20-30 years with chronic ankle instability (CAI), scoring 24 or less on the Cumberland Ankle Instability Tool (CAIT) questionnaire according to the International Ankle Consortium's CAI criteria; (ii) women aged 20-30 years with chronic ankle instability (CAI), scoring 24 or less on the Cumberland Ankle Instability Tool (CAIT) questionnaire according to the CAI criteria.
Key exclusion criteria
Those with a history of surgery of the lower limb (bone, joint, nerve, etc.), a history of fracture requiring alignment repair of the lower limb, a history of trauma (including sprains) within 3 months and experiencing an interruption of physical activity for at least one day. Those with a history of central nervous system disease, uncorrected visual impairment affecting postural control, a history of vertigo or inner ear disease, and those taking medication.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Sawada |
Organization
Saitama Medical University
Division name
School of Physical Therapy, Faculty of Health Care
Zip code
350-0496
Address
981 Kawakado Moroyama-Machi Iruma-Gun Saitama Japan
TEL
+81-49-295-1001
ysawada@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Sawada |
Organization
Saitama Medical University
Division name
School of Physical Therapy, Faculty of Health Care
Zip code
350-0496
Address
981 Kawakado Moroyama-Machi Iruma-Gun Saitama Japan
TEL
+81-49-295-1001
Homepage URL
ysawada@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Faculty of Health Care
School of Physical Therapy
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Faculty of Health Care
School of Physical Therapy
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
Ethical Committee of Saitama Medical University
Address
38 Morohongo Moroyama-Machi Iruma-Gun Saitama Japan
Tel
+81-49-276-2143
rinri@saitama-med.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 | 02 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 01 | 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
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062402
