NCT06296537

Brief Summary

The goal of this clinical trial is to determine and compare the effects of balance and dynamic neuromuscular stabilization training on ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance of amateur athletes with chronic ankle instability. The main questions it aims to answer are:

  • Do balance and dynamic neuromuscular stabilization training positively affect functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains?
  • Does balance training or dynamic neuromuscular stabilization training have a more positive effect on functionality, balance, stabilization, proprioception and performance in amateur athletes with chronic ankle sprains? Participants will apply:
  • a dynamic neuromuscular stabilization training program consisting of a series of special exercises based on the developmental kinesiology steps of a healthy baby.
  • balance training which consist of an effective postural stability program.
  • conventional training program which consist of stretching, joint range of motion, strengthening and postural control exercises. Researchers will compare balance and dynamic neuromuscular stabilization training to see if effectiveness of ankle function ability, functional instability severity, physical activity level, muscle strength, proprioception, stabilization, balance, reaction time and performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

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

First Submitted

Initial submission to the registry

February 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2024

Completed
Last Updated

December 19, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

February 29, 2024

Last Update Submit

December 16, 2024

Conditions

Keywords

Chronic Ankle InstabilityDynamic Neuromuscular Stabilization TrainingBalance TrainingAmateur AthletesStabilization

Outcome Measures

Primary Outcomes (2)

  • Star Excursion Balance Test

    The star excursion balance test is a test used to evaluate dynamic balance and dynamic postural stability. A small number of material installations are required to perform the star balance test. Four strips of athletic tape will each need to be cut to lengths ranging from 182.88 cm to 243.84 cm. Two pieces will be used to form a "+", the other two will be placed on top to form an "x", creating a star shape. All lines will be separated from each other at a 45° angle. The participant will maintain balance on the one foot while using other foot to reach as far as possible in 8 different directions. The participant will reach with his feet in 8 different directions: anterior, anteromedial, medial, posteromedial, posterior, posterolateral, lateral and anterolateral.

    Beginning of the study, and 6th week and 12th week after beginning the study

  • Balance Error Scoring System (BESS)

    BESS is a reliable and inexpensive tool to measure static balance in people with chronic foot instability. BESS consists of 6 tests that include both leg stance, one leg stance and tandem stance conditions, respectively, on both hard and foam surfaces with eyes closed. A stopwatch is used to determine participants' time during 20-second stance tests. The grading method is based on the score of the error table in the six tests. Errors include lifting the hip, walking, opening the eyes, grasping something, falling, leaving the test position after 5 seconds, flexion or abduction of the upper leg more than 30 degrees, and lifting the heel or front of the leg on the surface. If more than one mistake is made at the same time, they are counted as one mistake. The maximum total number of errors for any test is taken to be 10.

    Beginning of the study, and 6th week and 12th week after beginning the study

Secondary Outcomes (9)

  • Foot and Ankle Ability Measurement (FAAM)

    Beginning of the study, and 6th week and 12th week after beginning the study

  • Cumberland Ankle Instability Questionnaire

    Beginning of the study, and 6th week and 12th week after beginning the study

  • International Physical Activity Questionnaire - Short Form

    Beginning of the study, and 6th week and 12th week after beginning the study

  • Manual Muscle Strength Test with Hand Dynamometer

    Beginning of the study, and 6th week and 12th week after beginning the study

  • Single Heel Lift Test

    Beginning of the study, and 6th week and 12th week after beginning the study

  • +4 more secondary outcomes

Study Arms (3)

Dynamic Neuromuscular Stabilization Training Group

EXPERIMENTAL

A dynamic neuromuscular stabilization training program consisting of a series of special exercises based on the developmental kinesiology steps of a healthy baby will be prepared and applied for athletes in the DNS group. As the sessions progress, elastic bands will be used to create resistance in the exercises as the participants gain stabilization. All exercises will start with 1 set of 3 repetitions and increase to 1 set of 20 repetitions. All exercises will be performed barefoot.

Procedure: Dynamic Neuromuscular Stabilization Training (DNS)

Balance Training Group

EXPERIMENTAL

An intervention program will be prepared for balance training group in which balance training is added to an effective postural stability program. As the sessions progress, hand and ankle sandbags will be used together with the exercises. All exercises will start with 1 set of 10 repetitions and increase to 3 sets of 15 repetitions. Exercises will be performed barefoot.

Procedure: Balance Training

Conventional Training Group

ACTIVE COMPARATOR

A program including stretching, joint range of motion, strengthening and postural control exercises will be prepared for athletes in the conventional group. As the sessions progress, hand and ankle sandbags will be used together with the exercises. All exercises will start with 1 set of 10 repetitions and increase to 3 sets of 15 repetitions. Exercises will be performed barefoot.

Procedure: Conventional Training

Interventions

Dynamic neuromuscular stabilization training has been developed, which optimizes the movement system based on the scientific principles of developmental kinesiology. DNS training aims to stimulate the natural movement control system in the brain to activate the body's stabilization system. Supine, prone, oblique sitting, tripod, high kneeling, hanging stance-midstance faze, hanging stance- propulsion, bear, squat exercises will be applied.

Dynamic Neuromuscular Stabilization Training Group

Multi-plane single limb challenges, jumping and landing exercises, proprioceptive exercises, and perturbation exercises

Balance Training Group

Education, electrotherapy, soft tissue fascia massage, stretching, range of motion, strengthening and postural control exercises

Conventional Training Group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-25
  • Being a non-smoker
  • Being an athlete at amateur level
  • Score 25 or less on the Cumberland Ankle Instability Questionnaire
  • At least 1 acute ankle inversion sprain resulting in swelling, pain, and dysfunction that occurred at least 12 months before the study
  • Feeling of giving way in the ankle at least 2 times in the last 6 months

You may not qualify if:

  • If the patient has any mental problems
  • Neurological diseases
  • Cerebellar, vestibular, cochlear and inner ear dysfunction
  • Surgeries on musculoskeletal structures, chronic musculoskeletal disorders, severe acute lower extremity injuries or head trauma in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sevval Yeşilkır

Istanbul, Beşiktaş, 34347, Turkey (Türkiye)

Location

Related Publications (1)

  • Yesilkir S, Ergezen Sahin G. Dynamic neuromuscular stabilization, balance, and conventional training for chronic ankle instability in amateur athletes: a randomised controlled trial. BMC Sports Sci Med Rehabil. 2025 Oct 1;17(1):286. doi: 10.1186/s13102-025-01319-8.

MeSH Terms

Conditions

Chronic PainTinea Pedis

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousFoot DermatosesFoot DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPruritusSkin Manifestations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: It is designed as a prospective, randomized, controlled study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 29, 2024

First Posted

March 6, 2024

Study Start

April 1, 2024

Primary Completion

November 11, 2024

Study Completion

December 16, 2024

Last Updated

December 19, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations