Analysis of Sensory Motor Training in Chronic Ankle Instability

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ClinicalTrials.gov Identifier: NCT03768583

Recruitment Status : Completed

First Posted : December 7, 2018

Last Update Posted : August 20, 2019

Sponsor:

Information provided by (Responsible Party):

Universidade Estadual de Londrina

Study Description

Brief Summary:

Introduction: Sensory motor training (STS) is part of rehabilitation and injury prevention in individuals with chronic ankle instability (ICS). The use of footwear during SST may interfere with neuromuscular responses, but little is known about the difference in motor control response when training is applied with the use of shoes or bare feet. Objectives: To establish the effect of sensory motor training with and without sports shoes on the dynamic postural control of athletes with chronic ankle instability. Materials and Methods: The study will be performed with athletes linked to the Athletics of the State University of Londrina, aged between 18 and 30 years, both sexes, with chronic ankle instability assessed using the Cumberland Ankle Instability Tool (CAIT) questionnaire. Dynamic postural control will be evaluated in Force Platform and muscle recruitment through the electromyography of the muscles: anterior tibial, lateral and medial gastrocnemius, long fibular, gluteus maximus and gluteus medius. After the evaluation the volunteers will be randomized into two groups: 1) barefoot sensory-motor training and 2) sensory motor training with sneakers. The two groups will develop the same protocol of sensory motor training consisting of exercises, for five weeks, twice a week. At the end of the training they will be re-evaluated and the data analyzed. Expected Results: It is expected to find better postural control in the group that will perform in barefoot sensory-motor training.

Condition or disease	Intervention/treatment	Phase
Recruitment	Other: Group TSM ICT sneakers Other: Group TSM ICT barefoot Other: Group TSM health sneaker Other: Group TSM health barefoot	Not Applicable

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Detailed Description:

The total sample was determined in 54 volunteers, distributed equally in two groups: Chronic Ankle Instability and Control. Each group will be randomized for sensory-motor training with sneakers and without sneakers.

Inclusion criteria: athletes of both sexes, aged between 18 and 30 years, with history of ankle sprain in the last 12 months, sensation of instability or "yielding" of the ankle and score determined by the CAIT <24 questionnaire, did not perform sensory-motor training or conventional physiotherapy in the last six months.

Exclusion criteria: presence of pain complaints at the time of evaluation, recurrence of sprain with acute inflammatory signs, painful complaints in the lower limbs, lower limb surgery with neurological, cardiovascular, rheumatologic, diabetes, altered plantar sensitivity.

Participants with chronic ankle instability and controls will be randomly assigned to the two treatment groups, through the program www.ramdom.com, in blocks in the two groups: Sensory Motor Training Group with Tennis (TSMT) and Group Training Sensory Motor Barefoot ( TSMD).

Scratchs:

Since this is a study with intervention in participants with chronic ankle instability, there is a risk of new sprain during sensorimotor training. In case it occurs, the participant will receive all the support of the team coordinated by the professor Christiane Guerino de Souza Macedo in the extension project: Physiotherapy from theory to practice.

Procedures:

Initially the participants will complete the demographic data sheet (age, weight, height, BMI, level of physical activity and dominance in the lower limbs) and history of lower limb injury. Will respond to the chronic ankle instability questionnaire CAIT-p. They will sign the informed consent form (TCLE).

Following, the Lunge test will be performed to analyze ankle mobility. The same will be developed with the participant in orthostatism in front of a wall, with a tape measure, the participant will begin the test with a distance of 2cm from the wall and will be incremented by 1cm each time until the greater distance is reached. You will perform maximum knee flexion without the heel lifting from the floor or assuming a valgus position, with the goal of bringing the knee up to the wall. The result will be established by means of the halux-wall distance.

Postural control and muscle recruitment of a lower limb with the same direction should not be assessed by force platform and electromyography, respectively. The evaluations are made for the blind and according to the order of the instruments and the use or not of the shoe.

The anchoring of electromyographic analysis electrodes is performed on the anterior tibialis muscle (TA), lateral gastrocnemius (GL), medial gastrocnemius (GM), long fibularis (FL), gluteus maximus (GMe) and gluteus maximus (GMa). There will be a screening of electrotherapy supplements and cleaning of the area with alcohol rubbing (Moraes et al., 2012). The electrodes will be attached to the previous muscular points, according to the guide.

After placement of the electrodes the participant will be positioned with the lower limb to be tested on one step (based on height of applied force platform) and perform a series of assactions per second for thirty seconds controlled by metronome. This evaluation will be done 3 times. With a rest period of one full day in each test.

For an evaluation of dynamic postural control (BIOMEC400, Sistema EMG do Brasil, SP Ltda.). On the platform will be placed the member with chronic instability of the ankle and perform squatting to 30 seconds. With a rest period of one morning between each sitting test. They will be carried out 3 times with sneakers and 3 times with bare feet.

At this moment, the main parameters of COP-based postural control are: The area of COP ellipse (A-COP in cm²) and the mean COP oscillation distance (VEL in cm / s) are the most indicated in the directions: anteroposterior (A / P) and medium-lateral (M / L). Results were calculated for an average of three trials.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	29 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	Effect of Sensory Motor Training With and Without Sports Shoes on the Dynamic Postural Control of Athletes With Chronic Ankle Instability
Actual Study Start Date :	August 20, 2018
Actual Primary Completion Date :	July 20, 2019
Actual Study Completion Date :	July 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group TSM ICT sneakers ICT with sneaker five weeks twice a week half hour.	Other: Group TSM ICT sneakers Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
Experimental: Group TSM ICT barefoot ICT barefoot five weeks twice a week half hour.	Other: Group TSM ICT barefoot Sensory motor training without sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
Experimental: Group TSM health barefoot Health with sneaker five weeks twice a week half hour.	Other: Group TSM health barefoot Sensory motor training without sneaker for volunteers with Chronic ankle instability, for five weeks, twice a week.
Experimental: Group TSM health sneakers Health barefoot five weeks twice a week half hour.	Other: Group TSM health sneaker Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.

Outcome Measures

Primary Outcome Measures :

Postural control response after intervention [ Time Frame: twenty weeks ]
Response of sensorial motor training in improving motor control in volunteers with chronic ankle instability or not. Will use force platform.

Secondary Outcome Measures :

Muscle recruitment response after intervention [ Time Frame: twenty weeks ]
Response of sensorial motor training in the muscular recruitment of volunteers with chronic ankle instability or not, and the difference in response when performed with sneakers or barefoot. Will use electromyography.
measurement ankle dorsiflexion [ Time Frame: twenty weeks ]
The dorsiflexion will be mensure with the Lunge test in centimeter

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 30 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

athletes of both sexes
aged between 18 and 30 years,
with history of the first ankle sprain for at least 12 months,
feeling of instability or "flaccidity" of the ankle
score determined by the CAIT questionnaire of less than 24,
have not undergone sensory-motor or conventional physiotherapy training in the last six months.

Exclusion Criteria:

Withdrawal at the time of the evaluation,
Recurrence of sprain accompanied by signs of inflammation, acute and painful complaints in the lower group,
history of lower limb surgery, neurological, cardiovascular, rheumatologic, diabetes, altered plantar sensitivity.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768583

Locations

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Brazil
university hospital of the State University of Londrina
Londrina, Paraná, Brazil, 86038-350

Sponsors and Collaborators

Universidade Estadual de Londrina

Investigators

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Principal Investigator:	Christiane Macedo	State University of Londrina

More Information

Publications:

Hiller CE, Refshauge KM, Bundy AC, Herbert RD, Kilbreath SL. The Cumberland ankle instability tool: a report of validity and reliability testing. Arch Phys Med Rehabil. 2006 Sep;87(9):1235-41.

Konradsen L, Bech L, Ehrenbjerg M, Nickelsen T. Seven years follow-up after ankle inversion trauma. Scand J Med Sci Sports. 2002 Jun;12(3):129-35.

Heleno LR, da Silva RA, Shigaki L, Araújo CG, Coelho Candido CR, Okazaki VH, Frisseli A, Macedo CS. Five-week sensory motor training program improves functional performance and postural control in young male soccer players - A blind randomized clinical trial. Phys Ther Sport. 2016 Nov;22:74-80. doi: 10.1016/j.ptsp.2016.05.004. Epub 2016 May 10.

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Responsible Party:	Universidade Estadual de Londrina
ClinicalTrials.gov Identifier:	NCT03768583
Other Study ID Numbers:	Sensory motor training
First Posted:	December 7, 2018 Key Record Dates
Last Update Posted:	August 20, 2019
Last Verified:	July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Universidade Estadual de Londrina:


Postural Balace Physioteraphy Ankle Injuries Electromyography

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