UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049963 |
|---|---|
| Receipt number | R000056905 |
| Scientific Title | Effect of short foot exercise on lower limb control function during single-leg standing in people with flatfeet |
| Date of disclosure of the study information | 2023/01/05 |
| Last modified on | 2023/01/05 18:24:28 |
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Basic information
Public title
Effect of short foot exercise on lower limb control function during single-leg standing in people with flatfeet
Acronym
Effect of short foot exercise on lower limb control function during single-leg standing in people with flatfeet
Scientific Title
Effect of short foot exercise on lower limb control function during single-leg standing in people with flatfeet
Scientific Title:Acronym
Effect of short foot exercise on lower limb control function during single-leg standing in people with flatfeet
Region
| Japan |
Condition
Condition
flatfeet
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Flatfeet is a decreased arch structure, which causes lower limb musculoskeletal disorders.There are two possible factors that flatfeet contribute to lower- limb musculoskeletal disorders. The first is biomechanical factors. The other factor is neuromuscular control function. Intrinsic foot muscles play an important role to improve flatfeet because it contribute to these two factors. Short foot exercise activate intrinsic foot muscles, which is expected the effect on flatfeet. Therefore, the purpose of this study is to investigate the effect of short foot exercise on lower motor control function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The angle of hip abduction during single-leg standing at pre and post intervention for 8weeks.
Key secondary outcomes
Navicular drop test, Toe grip strength, planter sensation, and SLS at pre and post intervention for 8weeks. In the SLS assessment, we measured that the mean center of pressure amplitude in the anteroposterior and mediolateral directions, the onset time of gluteus maximus and gluteus medius, the angle of forefoot/hindfoot pronation and the lateral pelvic shift.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Short foot exercise shortens the foot while maintaining the subtalar joint and interphalangeal joints in a neutral position by contracting intrinsic foot muscles. The exercises were performed for 8 weeks with a 5-s hold and 5-s rest for 5 minutes. In the first four weeks, the participants performed the exercises while sitting. In the next 2 weeks, they performed standing, followed by SLS for the last 2 weeks. Online instructions were provided once per week.
Interventions/Control_2
Toe curl exercise flexes interphalangeal joints to elevate MLA by contracting not only intrinsic foot muscles, but also the extrinsic foot muscles.The exercises were performed for 8 weeks with a 5-s hold and 5-s rest for 5 minutes. In the first four weeks, the participants performed the exercises while sitting. In the next 2 weeks, they performed standing, followed by SLS for the last 2 weeks. Online instructions were provided once per week.
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People with flatfoot with a foot posture index of 6 (FPI6) more than 7.
Key exclusion criteria
The exclusion criteria were surgical experience on the measurement side of the lower limb, neurological symptoms, and excessive foot deformity.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Misaki |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba medical center
Division name
Rehabilitation
Zip code
2600842
Address
1-7-1 Minamicho Chuo-ku Chiba-shi Chiba Japan
TEL
0432615111
smsb482912@gmail.com
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba medical center
Division name
Rehabilitatin
Zip code
2600842
Address
1-7-1 Minamicho Chuo-ku Chiba-shi Chiba Japan
TEL
0432615111
Homepage URL
smsb482912@gmail.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Misaki Suzuki
Funding Source
Organization
None
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
Chiba medical center
Address
1-7-1 Minamicho Chuo-ku Chiba-shi Chiba Japan
Tel
0432615111
smsb48912@gmail.com
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
| 2023 | Year | 01 | Month | 05 | 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
36
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
| 2021 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 04 | 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
| 2023 | Year | 01 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056905
