NCT05799885

Brief Summary

Chronic ankle instability was first defined by Freeman as recurrent ankle sprains following an ankle sprain and the feeling of dislocation in the ankle lasting longer than six months. The recurrence of ankle sprains in athletes leads to the realization of ankle instability. Functional ankle instability gives the feeling that a re-sprain will occur at any time due to decreased static and dynamic support in the joint.Neuro-vestibular-ocular exercises is an approach that combines neuromuscular training and vestibular-ocular training techniques.At the same time, we are doing this study because of the mixed studies on the effect of fascial relaxation on the performance and proprioception of a specific group of football players.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 2, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

April 5, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

February 13, 2023

Last Update Submit

March 22, 2023

Conditions

Ankle Inversion SprainAnkle Injuries

Outcome Measures

Primary Outcomes (1)

  • CAIT Scale

    Participants will be included based on the CAIT questionnaire and who get 27 points or less from this questionnaire. In the test, cut off score of less or equal to 27 as indicate of chronic ankle instability. The precision of the instrument is increased as it is a multiple answer option instrument. The CAIT is able to measure the severity of instability by using a numeric value and also can be filled out for both the left and right ankle, making it possible to assess both ankles individually.

    a day before the rehabilitation-at the time of discharge(8 weeks)

Secondary Outcomes (5)

  • proprioception evaluation

    a day before the rehabilitation-at the time of discharge(8 weeks)

  • Landing Error Scoring System (LESS)

    a day before the rehabilitation-at the time of discharge(8 weeks)

  • 30 meters Sprint Test

    a day before the rehabilitation-at the time of discharge(8 weeks)

  • Zigzag agility test(with and without the ball)

    a day before the rehabilitation-at the time of discharge(8 weeks)

  • Kick Speed

    a day before the rehabilitation-at the time of discharge(8 weeks)

Study Arms (2)

31 players with ankle instability

EXPERIMENTAL

2 sessions per week for 8 weeks, total training time 30 min

Other: Myofascial Release group

30 players with ankle instability

EXPERIMENTAL

2 sessions per week for 8 weeks, total training time 30-40 min

Other: Neuro-vestibular-ocular group

Interventions

Neuro-vestibular-ocular groupOTHER

Neuro-vestibular-ocular exercise group (30 footballers)will do the exercises given in addition to their training

30 players with ankle instability
Myofascial Release groupOTHER

Manual myofascial release will be applied by the physiotherapist.(30 football players)

31 players with ankle instability

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • a history of 'giving way' and/or recurrent sprains and/or 'feeling of instability' in the injured ankle joint within the last 6 months.
  • decreased function due to ankle sprain history
  • "feeling of instability" will be defined as ≤27 points on the Cumberland ankle instability scale (CAIT) and the most affected side will be determined as the relevant limb for testing. CAIT score between right and left foot The dominant ankle will be selected.
  • Having had at least two previous lateral sprains in the same ankle.

You may not qualify if:

  • history of musculoskeletal surgery and/or fractures in the lower extremities;
  • acute injury to the musculoskeletal structures of other lower extremity joints in the last three months that affects joint integrity and function and causes interruption of desired physical activity for at least one day;
  • having a history of balance and vestibular disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Büşra

Istanbul, Maltepe, 34776, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Büşra Kocakılıç, master

    Yeditepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elif Tuğçe Çil, doctor

CONTACT

05544811092elif.cil@yeditepe.edu.tr

Büşra Kocakılıç, master

CONTACT

05388548632busrakocakilic@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

April 5, 2023

Study Start

April 2, 2023

Primary Completion

September 3, 2023

Study Completion

September 30, 2023

Last Updated

April 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)