NCT05455957

Brief Summary

The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance,isokinetic muscle strength and proprioception in subjects with ankle instability.The aim of the study is to compare the effects of neromuscular exercise combined with vestibulo-ocular reflex training on balance and isokinetic muscle strength in subjects with ankle instability. Hypotheses of the study; H0: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has an effect on isokinetic ankle muscle strength and balance in individuals with ankle instability. H1: Vestibulo-ocular reflex training protocol, which is given in addition to the neuromuscular exercise program, has no effect on isokinetic ankle muscle strength and balance in individuals with ankle instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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 10, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
Last Updated

July 13, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

June 10, 2022

Last Update Submit

July 10, 2022

Conditions

Keywords

ankle instability, balance, neuromuscular,vestibulo-ocular

Outcome Measures

Primary Outcomes (3)

  • balance,isokinetic muscle strength,proprioception

    Dynamic balance evaluation with star excursion balance test recorded in centimeters.

    1 hours

  • isokinetic muscle strength

    ankle evertor- inverter concentric muscle strength by using isokinetic dynamometer at angular velocities of 60 degree/s, 120 degree /s and 180 degree/s were recorded.

    1 hours

  • proprioception

    Proprioception was evaluated by measuring joint position sense with a goniometer, and deviations in proprioception were recorded as degrees.

    1 hours

Secondary Outcomes (2)

  • weight

    1 hours

  • height

    1 hours

Study Arms (2)

Neuromuscular Training

EXPERIMENTAL

The neuromuscular exercise training group includes single-leg stance, single leg hop and strength exercise.Each training session took approximately 60 minutes and 3 times a week for 4 weeks.The neuromuscular group included supervised, strength, balance and hop stabilization exercises on the different surfaces that focus on the restoring of static and dynamic balance. Both groups completed strength exercises in the same way. Strength exercises include ;4-way ankle theraband exercises,foot intrinsic strengthening (toe curl, doming),heel raises exercise,squat, lunge activities.Balance exercises include single-leg stance single leg hop and unticipated hop to stabilization activities.

Other: exercise

Vestibulo-Ocular Reflex Training

EXPERIMENTAL

The vestibulo ocular reflex training group includes head and gaze stability exercises in addition to single le stance,single leg hop and strength exercise.Each training session took approximately 60 minutes and 3 times a week for 4 weeks.In the vestibulo- ocular exercise program, individuals tried to maintain their balance with head and eye movements in addition to balance and hop stabilization activities. Both groups completed strength exercises in the same way. Strength exercises include ;4-way ankle theraband exercises,foot intrinsic strengthening (toe curl, doming),heel raises exercise,squat, lunge activities.Balance exercises include single-leg stance single leg hop and unticipated hop to stabilization activities.

Other: exercise

Interventions

neuromuscular and vestibulo-ocular training

Neuromuscular TrainingVestibulo-Ocular Reflex Training

Eligibility Criteria

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

You may qualify if:

  • Being 18-30 years old
  • At least 2 lateral sprains to the same ankle in the past
  • At least 1 episode of "giving way" that had occurred within the past 6 months
  • The presence of residual symptoms during functional activities and had to be free from symptoms of any other previous injury to the lower extremity.
  • No other injuries to the lower limbs

You may not qualify if:

  • Having a bilateral ankle instability
  • Having a history of ankle fracture
  • Having a history of fracture or surgery to the involved lower extremity
  • Having a history of balance and vestibular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sportomed

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

June 10, 2022

First Posted

July 13, 2022

Study Start

March 10, 2021

Primary Completion

September 16, 2021

Study Completion

February 4, 2022

Last Updated

July 13, 2022

Record last verified: 2022-06

Locations