NCT03768583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

August 20, 2019

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

July 21, 2018

Last Update Submit

August 15, 2019

Conditions

Keywords

Postural BalacePhysioteraphyAnkle InjuriesElectromyography

Outcome Measures

Primary Outcomes (1)

  • 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.

    twenty weeks

Secondary Outcomes (2)

  • Muscle recruitment response after intervention

    twenty weeks

  • measurement ankle dorsiflexion

    twenty weeks

Study Arms (4)

Group TSM ICT sneakers

EXPERIMENTAL

* ICT with sneaker * five weeks * twice a week * half hour.

Other: Group TSM ICT sneakers

Group TSM ICT barefoot

EXPERIMENTAL

* ICT barefoot * five weeks * twice a week * half hour.

Other: Group TSM ICT barefoot

Group TSM health barefoot

EXPERIMENTAL

* Health with sneaker * five weeks * twice a week * half hour.

Other: Group TSM health barefoot

Group TSM health sneakers

EXPERIMENTAL

* Health barefoot * five weeks * twice a week * half hour.

Other: Group TSM health sneaker

Interventions

Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.

Group TSM ICT sneakers

Sensory motor training without sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.

Group TSM ICT barefoot

Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.

Group TSM health sneakers

Sensory motor training without sneaker for volunteers with Chronic ankle instability, for five weeks, twice a week.

Group TSM health barefoot

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

university hospital of the State University of Londrina

Londrina, ParanĂ¡, 86038-350, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 16935061BACKGROUND
  • 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.

    PMID: 12135444BACKGROUND
  • 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.

    PMID: 27620862BACKGROUND

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Christiane Macedo

    State University of Londrina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2018

First Posted

December 7, 2018

Study Start

August 20, 2018

Primary Completion

July 20, 2019

Study Completion

July 30, 2019

Last Updated

August 20, 2019

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations