UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038852 |
|---|---|
| Receipt number | R000044307 |
| Scientific Title | Relationship between Mulligan Ankle MWM and Y-Balance test:an open-label,randomized controlled trial. |
| Date of disclosure of the study information | 2019/12/20 |
| Last modified on | 2023/12/20 21:41:10 |
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Basic information
Public title
Relationship between Mulligan Ankle MWM and Y-Balance test:an open-label,randomized controlled trial.
Acronym
Effects of manual therapy causes to balance function.
Scientific Title
Relationship between Mulligan Ankle MWM and Y-Balance test:an open-label,randomized controlled trial.
Scientific Title:Acronym
Effects of manual therapy causes to balance function.
Region
| Japan |
Condition
Condition
Balance dysfunction
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate the relationship between Manual therapy and Y-Balance test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Y-Balance test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Mugun Ankle MWM group
Repetition: the technic in sets of 20, 3 times a week.
Period:4weeks
Interventions/Control_2
Triceps surae stretching group
Repetition: 3 times a week for 3 min.
Period:4weeks
Interventions/Control_3
control group
Period:4weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
None of the subjects had prior personal experience with the exercise training utilized in the study.
Key exclusion criteria
The study exclusion criteria were any sign of leg pain, medical history, and evidence of musculoskeletal disease or neurological disease within the previous 6 months that could affect the motor function.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | takashi |
| Middle name | |
| Last name | shiroshita |
Organization
Gunma PAZ University
Division name
School of Physical Therapy, Faculty of Health Science,
Zip code
370-0006
Address
1-7-1 Tonyamachi, Takasaki-shi 370-0006, Gunma, Japan
TEL
027-388-0952
shiroshita@paz.ac.jp
Public contact
Name of contact person
| 1st name | takashi |
| Middle name | |
| Last name | shiroshita |
Organization
Gunma PAZ University
Division name
School of Physical Therapy, Faculty of Health Science,
Zip code
370-0006
Address
603Lab 1-7-1 Tonyamachi, Takasaki-shi 370-0006, Gunma, Japan
TEL
027-388-0952
Homepage URL
shiroshita@paz.ac.jp
Sponsor or person
Institute
Gunma PAZ University
Institute
Department
Personal name
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
Eehics review committee on research with human subjects gunma paz university
Address
1-7-1 Tonyamachi, Takasaki-shi 370-0006, Gunma, Japan
Tel
027-365-3366
naka@paz.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
| 2019 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
noe
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The abstract was submitted to the WPT in 2023 and was accepted. It was scheduled to be announced in early June. However, my family was hospitalized urgently and needed nursing care. Therefore, it was impossible for me to go on an overseas business trip, so I canceled it two days before. I plan to update the content of my presentation at IFSPT in 2024 (June 2023).
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
| 2020 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, a cross-sectional study was carried out as a progress. Presented in clinical sports medicine.(2020.12)
Data on 24 foots were collected and intervened. Currently being analyzed (2021.9)
The data analysis of 24 pairs has been almost completed, and we are planning to present it at the conference at IFPST2022. The abstract is currently being prepared. (2022.1)
The analysis of this study was completed and the abstract was registered and accepted in 2022IFSPT (WCSPT 2022) and was scheduled to be presented in Denmark on August 22nd and 23rd. However, the abstract was withdrawn due to the re-expansion of COVID-19. It will be announced at the WPT in 2023 (2022.7).
The abstract was submitted to the WPT in 2023 and was accepted. It was scheduled to be announced in early June. However,my family was hospitalized urgently and needed nursing care. Therefore, it was impossible for me to go on an overseas business trip, so I canceled it two days before of the WPT. I plan to update the content of my presentation at IFSPT in 2024 (June 2023).
It was scheduled to be presented at the World Physiotherapy Congress 2023 held in May 2023, but due to family misfortune, I was unable to travel and canceled it the day before. It is scheduled to be presented at the World Congress of Sports Physical Therapy 2024 to be held in Oslo, Norway(2023.12).
Management information
Registered date
| 2019 | Year | 12 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044307
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