UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034435 |
|---|---|
| Receipt number | R000039261 |
| Scientific Title | The effects of Inter-structure release and exercise for young subjects with varus thrust. |
| Date of disclosure of the study information | 2018/10/10 |
| Last modified on | 2018/10/10 12:39:55 |
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Basic information
Public title
The effects of Inter-structure release and exercise for young subjects with varus thrust.
Acronym
The effects of Inter-structure release and exercise for subjects with varus thrust.
Scientific Title
The effects of Inter-structure release and exercise for young subjects with varus thrust.
Scientific Title:Acronym
The effects of Inter-structure release and exercise for subjects with varus thrust.
Region
| Japan |
Condition
Condition
Healthy females with varus thrust
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the effects of Inter-structure release and exercise on healthy females with varus thrust.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
immediate effects of 1) alignment, 2) body sway, 3) planter pressure distribution
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Inter-structure release (about 15 min.) and exercise with tibial internal-rotation
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
1) a healthy female, 2)without gait dysfunction or pain
Key exclusion criteria
1) operative history of lower limb, 2)pain of lower limb
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Gamada |
Organization
Hiroshima International University
Division name
Division of Physical Therapy
Zip code
Address
555-36, Kurosegakuendai, Higashihiroshima
TEL
0823-70-4550
kazgamada@ortho-pt.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Gamada |
Organization
Hiroshima International University
Division name
Division of Physical Therapy
Zip code
Address
555-36, Kurosegakuendai, Higashihiroshima
TEL
0823-70-4550
Homepage URL
kazgamada@ortho-pt.com
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
Non
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
広島国際大学（広島県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 10 | 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
| 2016 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 10 | Day |
Last modified on
| 2018 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039261
