- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03768583
Analysis of Sensory Motor Training in Chronic Ankle Instability
Effect of Sensory Motor Training With and Without Sports Shoes on the Dynamic Postural Control of Athletes With Chronic Ankle Instability
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Paraná
-
Londrina, Paraná, Brazil, 86038-350
- university hospital of the State University of Londrina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Sensory motor training without sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
|
Experimental: 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
|
Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
twenty weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
twenty weeks
|
measurement ankle dorsiflexion
Time Frame: twenty weeks
|
The dorsiflexion will be mensure with the Lunge test in centimeter
|
twenty weeks
|
Collaborators and Investigators
Publications and helpful links
General 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. doi: 10.1016/j.apmr.2006.05.022.
- 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. doi: 10.1034/j.1600-0838.2002.02104.x.
- Heleno LR, da Silva RA, Shigaki L, Araujo 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Sensory motor training
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Recruitment
-
NYU Langone HealthCompleted
-
University of California, San FranciscoCompleted
-
Assistance Publique - Hôpitaux de ParisTerminated
-
Peking Union Medical College HospitalUnknown
-
Mansoura UniversityCompleted
-
The Royal Wolverhampton Hospitals NHS TrustWithdrawn
-
Emergency Medical Services, Capital Region, DenmarkAalborg UniversityUnknownRecruitment | BLSDenmark
-
Balikesir UniversityActive, not recruitingRecruitment | Hysterectomy | Optic NerveTurkey
-
Second Affiliated Hospital, School of Medicine,...UnknownRecruitment of ParticipantsChina
Clinical Trials on Group TSM ICT sneakers
-
University of OuluActive, not recruiting
-
Université du Québec à Trois-RivièresCompleted