UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The stimulation somatosensory affects the ankle instability and sprain incidence
Title of the study (Brief title)	The stimulation somatosensory affects the ankle instability and sprain incidence
Region	Japan

Condition
Condition	ankle instability
Classification by specialty	Orthopedics Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to reveal the effects of balance training and TENS. The participants are athletes who suffer with ankle instability. They were measured their muscular strength, muscle reaction time, balance test, EMG test, a jump test. Furthermore, researchers examine the influence of balance training and TENS to the ankle instability and performance. In addition the effects for ankle sprain incidence rate of each intervention were also investigated.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	The incidence of ankle instability
Key secondary outcomes	(1) We have 4 times measurements at a start and 6th week, 12th week, 24th week. The measurements contain balance test, muscle reaction time, muscle activity on jump performance, muscle strength. (2) Side effects of the TENS (skin rash, burning sensation).

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Intervention: Balance training (Basic treatment) and TENS (Under the guidance of the head research representatives gives, the participants are attached with the electrode pads onto the muscle of the peroneus longus and the peroneus brevis by themselves, and are performed with 5 Hz electric stimulations for 15 minutes 3times a week for 24 weeks period.)
Interventions/Control_2	Control: Balance training (Basic treatment)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Karlsson Score<80, or CAIT<27
Key exclusion criteria	A person visiting a hospital for treatment because of a primary illness and the person who takes medication.(diabetes, heart disease, kidney disease, liver disease, hyponatremia, refractory hypertension) The person who has the medical history of lower limbs surgery. The person who has difficulty to exercise due to an ankle instability which is high excessively.
Target sample size	19

Research contact person
Name of lead principal investigator	YOSHIDA NARUTO
Organization	Teikyo Heisei University
Division name	Faculty of Health Care
Address	Toshima-ku, Tokyo 170-8445, Japan
TEL	81358433111
Email	n.yoshida@thu.ac.jp

Public contact
Name of contact person	YOSHIDA NARUTO
Organization	Teikyo Heisei University
Division name	Faculty of Health Care
Address	Toshima-ku, Tokyo 170-8445, Japan
TEL	81358433111
Homepage URL
Email	n.yoshida@thu.ac.jp

Sponsor
Institute	Teikyo Heisei University
Institute
Department

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)

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	筑波大学（茨城県）、茨城大学（茨城県）、福岡大学（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 30 Day
Anticipated trial start date	2014 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 12 Day
Last modified on	2016 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017232