UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053917 |
|---|---|
| Receipt number | R000061319 |
| Scientific Title | Effects of talocrural joint mobilization on joint position sense and center of gravity in patients with chronic ankle instability |
| Date of disclosure of the study information | 2024/03/20 |
| Last modified on | 2024/03/20 21:59:50 |
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Basic information
Public title
Effects of talocrural joint mobilization on joint position sense and center of gravity in patients with chronic ankle instability
Acronym
Effects of talocrural joint mobilization on joint position sense and center of gravity in patients with chronic ankle instability
Scientific Title
Effects of talocrural joint mobilization on joint position sense and center of gravity in patients with chronic ankle instability
Scientific Title:Acronym
Effects of talocrural joint mobilization on joint position sense and center of gravity in patients with chronic ankle instability
Region
| Japan |
Condition
Condition
chronic ankle instability
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of talofemoral joint mobilization on joint position sense and center of gravity sway in patients with chronic ankle instability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Joint position sense in ankle joint supination before and after intervention
Key secondary outcomes
Center of gravity sway test in open eye one legged standing position before and after intervention
Ankle dorsiflexion angle as an index of toe wall distance before and after intervention
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
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Maitland Grade II talocrural joint mobilization
Interventions/Control_2
Maitland Grade III talocrural joint mobilization
Interventions/Control_3
Sham
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
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults between the ages of 18 and 30
Japanese Cumberland Ankle Instability Tool (CAIT) score of 25 or less
At least one ankle sprain
Have a history of ankle giving-way
Key exclusion criteria
Who have suffered an acute ankle sprain within the past 6 weeks
Who have suffered a lower limb injury within the past 6 months
Persons with diabetes or other diseases that affect balance func,on
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Murayama |
Organization
Tokyo Metropolitan University
Division name
Human Health Sciences College of Physical Therapy Sciences
Zip code
1160012
Address
2-10 Higashi-Oku, Arakawa-ku, Tokyo
TEL
0338191211
22895714@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Hirokazu |
| Middle name | |
| Last name | Murayama |
Organization
Tokyo Metropolitan University
Division name
Human Health Sciences College of Physical Therapy Sciences
Zip code
1160012
Address
2-10 Higashi-Oku, Arakawa-ku, Tokyo
TEL
0338191211
Homepage URL
22895714@ed.tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
without
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
Tokyo Metropolitan University
Address
2-10 Higashi-Oku, Arakawa-ku, Tokyo
Tel
0338191211
22895714@ed.tmu.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
| 2024 | Year | 03 | Month | 20 | 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
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
