UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012427 |
|---|---|
| Receipt number | R000014544 |
| Scientific Title | Balance ability and exercise capacity in patients with hallux valgus Comparison before and after surgery |
| Date of disclosure of the study information | 2013/11/28 |
| Last modified on | 2020/06/18 20:18:37 |
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Basic information
Public title
Balance ability and exercise capacity in patients with hallux valgus Comparison before and after surgery
Acronym
Balance ability and exercise capacity in patients with hallux valgus before and after surgery
Scientific Title
Balance ability and exercise capacity in patients with hallux valgus Comparison before and after surgery
Scientific Title:Acronym
Balance ability and exercise capacity in patients with hallux valgus before and after surgery
Region
| Japan |
Condition
Condition
Hallux valgus
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate balance ability and exercise capacity in patients with hallux valgus and to compare with healthy adults and examine the effectiveness of surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The balance ability and exercise capacity at the time of one year or more of postoperative progress are evaluated.
Evaluation with plantar pressure distribution and a center-of-gravity agitation meter, a radiographic assessment, and a questionnaire are performed.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
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
The patients that would have been hospitalized for the purpose of operative treatment for a symptomatic hallux valgus from January 2013 to December 2015 will be included in the group of hallux valgus.
Interventions/Control_2
The subjects that passed more than one year after surgery are included in the postoperative group.
Interventions/Control_3
Healthy adults without history of foot injury or complaints and obvious lower limbs deformity on inspection are included in control group.
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
Female
Key inclusion criteria
The patients that have been hospitalized for the purpose of operative treatment for a symptomatic hallux valgus are included in the group of hallux valgus. The subjects that passed more than one year after surgery are included in the postoperative group. Healthy adults without history of lower limbs injury or complaints and obvious lower limbs deformity on inspection are included in control group.
Key exclusion criteria
The subjects with history of lower limbs injury or surgery and have a neurological disorder are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi Neo |
Organization
Osaka Medical College
Division name
Department of Orthopedic Surgery
Zip code
Address
2-7, Daigaku-machi, Takatsuki-shi, Osaka, Japan
TEL
072-683-1221
neo@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jotoku Tsuyoshi |
Organization
Osaka Medical College
Division name
Department of Orthopedic Surgery
Zip code
Address
2-7, Daigaku-machi, Takatsuki-shi, Osaka, Japan
TEL
072-683-1221
Homepage URL
ort032@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of Orthopedic Surgery, Osaka Medical College
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
Address
Tel
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
| 2013 | Year | 11 | Month | 28 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 18 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 18 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 18 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 28 | Day |
Last modified on
| 2020 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014544
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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