UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034844 |
|---|---|
| Receipt number | R000039672 |
| Scientific Title | The effect of balance shoes training on knee wobbling during single leg squat; randomized clinical trial |
| Date of disclosure of the study information | 2018/11/09 |
| Last modified on | 2023/06/20 10:14:10 |
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Basic information
Public title
The effect of balance shoes training on knee wobbling during single leg squat; randomized clinical trial
Acronym
The effect of balance shoes training on knee wobbling
Scientific Title
The effect of balance shoes training on knee wobbling during single leg squat; randomized clinical trial
Scientific Title:Acronym
The effect of balance shoes training on knee wobbling
Region
| Japan |
Condition
Condition
Healthy and Anterior cruciate ligament injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of balanceshoes traing on knee wobbling during squat and landing tasks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee kinematics and kinetics
EMG of thigh and hip muscles
Key secondary outcomes
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
5 exercises with balanceshoes.
For first 2weeks, subejects performed level 1 exercises and after then they performed level 2 exersices.The number of exercises is 3 times per a week during 4 weeks.It takes 15 minutes.
Interventions/Control_2
5 exercises without balanceshoes.
For first 2weeks, subejects performed level 1 exercises and after then they performed level 2 exersices.The number of exercises is 3 times per a week during 4 weeks.It takes 15 minutes.
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
18~25 years old
sports participants with single leg tasks and landing tasks
Who has knee wobbling during single leg squat
Key exclusion criteria
bone fracture of lower extremity, abarticulation, pain during exercises, range of motion restriction, psychiatric disorder, who has problems with communication and understanding this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Gamada |
Organization
Hiroshima International University
Division name
Graduate School of Medical Technology and Health Welfare Sciences
Zip code
7392695
Address
555-36 Kurosegakuendai Higashihiroshima Hiroshima Japan
TEL
0823704510
kazgamada@ortho-pt.com
Public contact
Name of contact person
| 1st name | Akino |
| Middle name | |
| Last name | Aoki |
Organization
Hiroshima International University
Division name
Graduate School of Medical Technology and Health Welfare Sciences
Zip code
7392695
Address
555-36 Kurosegakuendai Higashihiroshima Hiroshima Japan
TEL
0823704510
Homepage URL
aj.spman154@gmail.com
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
None
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
Hiroshima International University
Address
555-36 Kurosegakuendai Higashihiroshima Hiroshima Japan
Tel
0823704510
aj.spman154@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
| 2018 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
8
Results
There were no significant differences in the numbers of F/S spikes that appeared in the post-intervention measurement for both valgus (p = .846) and varus (p = .298) movements between groups.
Results date posted
| 2020 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants were recruited from female basketball or volleyball team on campus with verbal communication and/or a printed paper.
Participant flow
Ten basketball athletes and 20 volleyball athletes were asked to participate in this study, among which ten athletes (four basketball and 6 volleyball athletes) agreed to participate. Written informed consent was obtained from each participant prior to testing. All ten athletes were proceeded to the screening session.
Adverse events
None
Outcome measures
Knee kinematics and kinetics
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039672
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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