UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055162 |
|---|---|
| Receipt number | R000063009 |
| Scientific Title | Investigation of the Causes and Improvement of Hallux Valgus |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2024/08/05 13:14:36 |
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Basic information
Public title
Investigation of the Causes and Improvement of Hallux Valgus
Acronym
Investigation of the Causes and Improvement of Hallux Valgus
Scientific Title
Investigation of the Causes and Improvement of Hallux Valgus
Scientific Title:Acronym
Investigation of the Causes and Improvement of Hallux Valgus
Region
| Japan |
Condition
Condition
hallux valgus
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the effects of intrinsic foot muscle training, orthotics, and the combination of both on the improvement or prevention of hallux valgus in female dancers and the general population. Additionally, it investigates whether wearing shoes with different toe box widths can lead to a decline in foot function and muscle strength involved in the foot.
The results of this study suggest that the use of shoes with a narrow toe box may restrict the movement of intrinsic foot muscles, thereby impacting balance and foot morphology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire Survey:
Participants will provide their physical information and details about any injuries. Pain and swelling in the foot will be assessed using foot photographs and pain levels will be measured using the Numerical Rating Scale (NRS). Additionally, the Manchester-Oxford Foot Questionnaire (MOFQ) and the Foot and Ankle Outcome Score (FAOS) will be used to evaluate foot conditions.
Measurement of Hallux Valgus Angle:
Foot photographs will be taken using a digital camera in a manner similar to taking X-rays. The hallux valgus angle will be measured from these photographs using ImageJ software.
Plantar Pressure Measurement:
Plantar pressure will be measured using the F-Scan system (Nitta Corporation) during various postures: standing on both feet (5 seconds), standing on one foot (5 seconds), and maximum heel lift (5 seconds). Each action will be performed once for both feet.
Muscle Activity Evaluation:
Surface electromyography (PLUX Biosignals, Lisbon, Portugal) will be used to measure muscle activity during double-leg standing, single-leg standing, and heel lift movements. The muscles to be evaluated include the abductor hallucis (center of the line connecting the navicular and medial calcaneal tubercle), abductor digiti minimi (1 cm posterior to the distal fifth metatarsal), flexor hallucis longus (posterior to the medial malleolus), tibialis anterior (inversion of the ankle), and peroneus longus (proximal third between the fibular head and lateral malleolus).
ROM Evaluation:
The range of motion (ROM) of the ankle will be assessed using a digital camera.
Intrinsic Muscle Training:
Based on previous studies, intrinsic muscle training methods such as towel curls, short foot exercises, and toe games (rock-paper-scissors) will be used. The aim is to determine whether these exercises can contribute to the improvement of hallux valgus.
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
| Maneuver |
Interventions/Control_1
Foot Exercise Self-Rehabilitation Program
Our foot exercise self-rehabilitation program was meticulously designed based on previous studies and clinical experience. The program included the following exercises:
1st MTP Joint Abduction via Manual Stretching
Toes-Spread-Out Exercise
Short Foot Exercise
Foot "Rock-Paper-Scissors" Exercise
Program Implementation
Education and Focus: All participants were thoroughly educated about the foot exercise program. They were instructed to focus on the sensation of their muscles being activated during the exercises.
Routine: Participants performed the same exercise routine with bare feet, 7 days a week for 4 weeks.
Materials Provided: Each participant received an illustrated, narrative brochure containing detailed information about the foot exercise program.
Daily Follow-Up: Participants were followed up once a day via a mobile phone application to track the completion status of the program.
Weekly In-Person Follow-Up: In-person follow-ups were conducted once a week to:
Provide additional guidance
Correct any potential issues with the program
Inquire about the participants' subjective experience and completion of the rehabilitation program over the past week (a total of 3 times).
This structured approach ensured that participants could effectively engage in the rehabilitation program, with regular support and adjustments to maximize their benefits from the exercises.
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
| 12 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
As an adolescent competitive dancer, I have undergone over a year of specialized training.
Key exclusion criteria
Participants were excluded if they had any orthopedic or other foot injuries and symptoms (such as pain and swelling) in the past year, if they were undergoing treatment for HV or other foot injuries, or if they were using NSAIDs or analgesic drugs.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Zijian |
| Middle name | |
| Last name | Liu |
Organization
waseda university
Division name
Graduate School of Sport Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa
TEL
08021881941
ryuushikenn10611@fuji.waseda.jp
Public contact
Name of contact person
| 1st name | Zijian |
| Middle name | |
| Last name | Liu |
Organization
waseda university
Division name
Graduate School of Sport Sciences
Zip code
3591192
Address
2-579-15 Mikajima, Tokorozawa
TEL
08021881941
Homepage URL
ryuushikenn10611@fuji.waseda.jp
Sponsor or person
Institute
waseda university
Institute
Department
Personal name
Funding Source
Organization
waseda university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
waseda university
Address
2-579-15 Mikajima, Tokorozawa
Tel
03-5272-4652
rps-management@list.waseda.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 | 08 | Month | 06 | 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
13
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
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 01 | 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 | 08 | Month | 05 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063009
