UMIN-CTR Clinical Trial

Basic information
Public title	Dr. Miri
Acronym	Dr
Scientific Title	Effect of six weeks Balance Training on Sensory organization and Postural control and Functional index in the Perturbation in athletes with chronic ankle instability
Scientific Title:Acronym	Effect of six weeks Balance Training on Sensory organization and Postural control and Functional index in the Perturbation in athletes with chronic ankle instability
Region	Asia(except Japan)

Condition
Condition	completed
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to evaluate the effect of six weeks of balance training on sensory organization and postural control and functional index in the perturbation in athletes with chronic ankle instability by manipulating sensory, visual and auditory information
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The results showed that the average score of Sensory organization and Postural control and Functional index in the experimental group after six weeks of training in each of the six conditions is higher than that of the control group
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	expanded access
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	Educational,Counseling,Training
Type of intervention	Other
Interventions/Control_1	six weeks of balance training against perturbation
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	25 years-old <=
Age-upper limit	35 years-old >=
Gender	Male and Female
Key inclusion criteria	having ankle sprain
Key exclusion criteria	fracture or pain in ankle
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hadi Middle name Last name Miri
Organization	Amirkabir University of Technology University, Tehran, Iran
Division name	Department of Physical Education and Sport Sciences, School of Physical Education and Sport Sciences
Zip code	1591634311
Address	No. 350, Hafez Ave, Valiasr Square, Tehran, Iran
TEL	09126169468
Email	hd.miri@aut.ac.ir

Public contact
Name of contact person	1st name Hadi Middle name Last name Miri
Organization	Amirkabir University of Technology University, Tehran, Iran
Division name	Department of Physical Education and Sport Sciences, School of Physical Education and Sport Sciences
Zip code	1591634311
Address	No. 350, Hafez Ave, Valiasr Square, Tehran, Iran
TEL	09126169468
Homepage URL
Email	hd.miri@aut.ac.ir

Sponsor
Institute	Amirkabir University of Technology University, Tehran, Iran
Institute
Department

Funding Source
Organization	Amirkabir University of Technology University, Tehran, Iran
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	Amirkabir University of Technology University, Tehran, Iran
Address	No. 350, Hafez Ave, Valiasr Square, Tehran, Iran
Tel	09126169468
Email	hd.miri@aut.ac.ir

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	2021 Year 08 Month 05 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	30
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	2021 Year 05 Month 05 Day
Date of IRB	2021 Year 05 Month 21 Day
Anticipated trial start date	2021 Year 06 Month 06 Day
Last follow-up date	2021 Year 07 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 27 Day
Last modified on	2021 Year 07 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051387