NCT03872973

Brief Summary

The aim of this study is to investigate the effect of neuromuscular training on balance by using stroboscopic glasses in athletes with chronic ankle instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 6, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

3 months

First QC Date

March 6, 2019

Last Update Submit

December 7, 2019

Conditions

Keywords

balancechronic ankle instabilityfunctionrunning

Outcome Measures

Primary Outcomes (6)

  • FAAM (Foot and Ankle Ability Measure),

    Pre-test evaluation will be done. After the end of neuromuscular training for 6 weeks, the final test will be evaluated. This value will be saved as %.

    8 weeks

  • Ankle ROM

    The two bars of Optojump are placed on the treadmill with a speed of 3.5m / sec and the foot strokes, imbalance and heel strokes will be recorded and the normal joint movements of the ankle with the Myo-motion device will be recorded.

    2 weeks

  • Balance

    Static and dynamic balances of athletes before and after neuromuscular training will be evaluated. Center of pressure area (COP) foot pressure point shall be evaluated in mm. And İt is defined as a measure indicative of the time and/or distance a subject spent away from a central point.

    2 weeks

  • EEG (Electroencephalography)

    The theta and beta waveform of EEG values of people will be measured during the static and dynamic balance evaluation.

    2 weeks

  • FAAM-S (Foot and Ankle Ability Measure Sport Scale)

    Pre-test evaluation will be done. After the end of neuromuscular training for 6 weeks, the final test will be evaluated. The Sports subscale is scored the same as FAAM (Foot and Ankle Ability Measure) 4 being 'no difficulty at all' to 0 being 'unable to do'. The score on each item are added together to get the item score total. The number of items with a response is multiplied by 4 to get the highest potential score. If the subject answers all 8 items the highest potential score is 32, if one item is not answered the highest potential score is 28, if two are not answered the highest potential score is 24, etc. The item score total is divided by the highest potential score. This value is multiplied by 100 to get a percentage. A higher score represents a higher level of physical function.

    8 weeks

  • BMI (Body Mass Index)

    Body mass index will be calculated before neuromuscular training. It will be evaluated in kg/m2.

    2 weeks

Study Arms (3)

Training Group

EXPERIMENTAL

Neuromuscular training will be performed in this group for 6 weeks.

Other: Neuromuscular Training

Strobe Group

EXPERIMENTAL

This group will perform neuromuscular training for 6 weeks with a strobe glasses.

Other: Neuromuscular TrainingOther: Strobe Glasses

Control Group

NO INTERVENTION

This group will not perform any neuromuscular training program.

Interventions

The experimental group will perform neuromuscular exercise for 6 weeks. The other experimental group will perform neuromuscular exercises with strobe glasses.

Strobe GroupTraining Group

Stroboscopic glasses, which is characterized by intermittent vision obstruction, is a clinical tool that allows clinicians to examine sensory feedback in a progressive manner without fully seeing visual information.

Strobe Group

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To have at least 5 years active athletes in any sports branch.
  • The first sprain history of individuals should be inflammatory symptoms (pain, swelling) at least 1 year before the study,
  • Individuals should have unilateral ankle sprain,
  • The newest sprain must have occurred 3 months before or after the date of commencement,
  • Individuals must have at least 2 times a feeling of instability within 6 months,
  • Individuals should not have any ankle fractures in the past
  • Individuals should have undergone no surgical procedure to affect the sensorimotor function in the lower extremity.
  • IDFAI (Identification of Functional Ankle Instability Questionare) score is above 11,
  • FAAM (Foot and Ankle Ability Measure) score less than 90%,
  • FAAM-S (Foot and Ankle Ability Measure Sport Scale) score should be less than 80%.

You may not qualify if:

  • Individuals who are not active athletes for at least 5 years in any sports branch.
  • First sprain history of individuals with inflammatory symptoms (pain, swelling) at least 1 year before the study.
  • The absence of unilateral ankle sprain by individuals.
  • The most recent buckling is that it did not take place 3 months before or after the date of commencement.
  • Individuals should not have a feeling of instability for at least 2 times within 6 months.
  • People experience ankle fractures in the past.
  • Individuals have undergone surgery to affect the sensorimotor function in the lower extremity.
  • IDFAI (Identification of Functional Ankle Questionability) score not more than 11.
  • FAAM (Foot and Ankle Ability Measure) score not less than 90%. FAAM-S (Foot and Ankle Ability Measure Sport Scale) score not less than 80%.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serkan UZLAŞIR

Nevşehir, Merkez, 50300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Serkan UZLAŞIR

    Nevşehir Hacı Bektaş Veli University Sports Science Laboratory

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 6, 2019

First Posted

March 13, 2019

Study Start

March 5, 2019

Primary Completion

June 10, 2019

Study Completion

October 12, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations