RecruitmentNCT03768583
Analysis of Sensory Motor Training in Chronic Ankle Instability
A study testing Group TSM ICT sneakers, Group TSM ICT barefoot and Group TSM health sneaker in people with Recruitment, run by Universidade Estadual de Londrina at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Recruitment
- What is being tested?
- Group TSM ICT sneakers, Group TSM ICT barefoot and Group TSM health sneaker
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Aug 2018to 30 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
university hospital of the State University of Londrina
Londrina, Paraná, 86038-350
About this study
Official title: Effect of Sensory Motor Training With and Without Sports Shoes on the Dynamic Postural Control of Athletes With Chronic Ankle Instability
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.
Read the 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.
- Conditions
- Recruitment
- Being tested
- Group TSM ICT sneakers, Group TSM ICT barefoot, Group TSM health sneaker, Group TSM health barefoot
- Keywords
- Postural Balace, Physioteraphy, Ankle Injuries, Electromyography
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group TSM ICT sneakersOther
Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
Group TSM ICT barefootOther
Sensory motor training without sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
Group TSM health sneakerOther
Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
Group TSM health barefootOther
Sensory motor training without sneaker for volunteers with Chronic ankle instability, for five weeks, twice a week.
| Study group | Role | What they receive |
|---|---|---|
| Group TSM ICT sneakers | Experimental | * ICT with sneaker
* five weeks
* twice a week
* half hour. Receives: Other: Group TSM ICT sneakers |
| Group TSM ICT barefoot | Experimental | * ICT barefoot
* five weeks
* twice a week
* half hour. Receives: Other: Group TSM ICT barefoot |
| Group TSM health barefoot | Experimental | * Health with sneaker
* five weeks
* twice a week
* half hour. Receives: Other: Group TSM health barefoot |
| Group TSM health sneakers | Experimental | * Health barefoot
* five weeks
* twice a week
* half hour. Receives: Other: Group TSM health sneaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural control response after intervention
Response of sensorial motor training in improving motor control in volunteers with chronic ankle instability or not. Will use force platform.
Measured: twenty weeks
Secondary outcomes (2)
Muscle recruitment response after intervention
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.
Measured: twenty weeks
measurement ankle dorsiflexion
The dorsiflexion will be mensure with the Lunge test in centimeter
Measured: twenty weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start20 Aug 2018
- Primary completion20 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RecruitmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christiane Macedo, Principal investigator, State University of Londrina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768583
- Sponsor's protocol ID
- Sensory motor training
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2018
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16935061Konradsen 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.
PubMed 12135444Heleno 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.
PubMed 27620862
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sensory Motor Training With and Without Sports Shoes on the Dynamic Postural Control of Athletes With Chronic Ankle Instability
- ClinicalTrials.gov ID
- NCT03768583
- Acronym / sponsor ID
- Sensory motor training
- Conditions
- Recruitment
- Keywords
- Postural Balace, Physioteraphy, Ankle Injuries, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group TSM ICT sneakers | Experimental | Other: Group TSM ICT sneakers* ICT with sneaker * five weeks * twice a week * half hour. |
| Group TSM ICT barefoot | Experimental | Other: Group TSM ICT barefoot* ICT barefoot * five weeks * twice a week * half hour. |
| Group TSM health barefoot | Experimental | Other: Group TSM health barefoot* Health with sneaker * five weeks * twice a week * half hour. |
| Group TSM health sneakers | Experimental | Other: Group TSM health sneaker* Health barefoot * five weeks * twice a week * half hour. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group TSM ICT sneakersSensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week. | Other | Group TSM ICT sneakers |
| Group TSM ICT barefootSensory motor training without sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week. | Other | Group TSM ICT barefoot |
| Group TSM health sneakerSensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week. | Other | Group TSM health sneakers |
| Group TSM health barefootSensory motor training without sneaker for volunteers with Chronic ankle instability, for five weeks, twice a week. | Other | Group TSM health barefoot |
Primary outcome
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.
2 secondary outcomes
Muscle recruitment response after intervention
Time frame: twenty weeks
measurement ankle dorsiflexion
Time frame: twenty weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Background: PubMed 16935061Hiller 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.
- Background: PubMed 12135444Konradsen 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.
- Background: PubMed 27620862Heleno 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christiane Macedo principal investigator
State University of Londrina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group TSM ICT sneakers, Group TSM ICT barefoot and Group TSM health sneaker in people with Recruitment, run by Universidade Estadual de Londrina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural control response after intervention (time frame: twenty weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768583, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.