NCT05602233

Brief Summary

Chronic ankle instability (CAI) is defined as the symptoms continuing 12 months after the first sprain and the functional and/or mechanical instability reported by the individual. The number of researches that include a combined treatment approach that will affect both sensory and motor components in rehabilitation strategies applied for CAI is limited. The aim of this study is to isolated sensory, isolated motor and combined targeted approaches for the treatment of chronic ankle instability (CAI); to compare the effects on postural control, range of motion, function and kinesiophobia and to contribute to an effective approach related to the applicability of Sensory-Targeted Ankle Rehabilitation Strategies in the treatment of CAI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

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

October 26, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

October 26, 2022

Last Update Submit

January 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postural control evaluation change

    Star excursion balance test (SEBT): The star excursion balance test is frequently used to evaluate the dynamic balance and postural control of the lower extremities. SEBT, is a test that measures the maximum reach of the individual by maintaining balance and performing a single-leg squat in lines drawn at 45 degrees intervals in eight different directions. The participant stands in the middle of the star shape with bare feet. For the starting position, the ankle should be stationary, the hands on the hips, and the participant should maintain the starting position throughout the test. The participant is asked to reach anteriorly, posteromedially and posterolaterally with the unstable ankle, make a light touch to the line, and rotate the outstretched leg back to the center while maintaining a one-leg stance with the other leg.The participant will be allowed to make 4 trials in each direction

    Change from Baseline postural control at 6 weeks

Secondary Outcomes (3)

  • Ankle dorsiflexion measurement change

    Change from baseline ankle dorsiflexion measurement at 6 weeks

  • Function change

    Change from baseline ankle function measurement at 6 weeks

  • Kinesiophobia change

    Change from baseline kinesiophobia measurement at 6 weeks

Study Arms (3)

Balance training:

EXPERIMENTAL

It is planned to apply hop to stabilization exercises developed by Mckeon et al. The training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors.

Other: Exercise

STARS

EXPERIMENTAL

A combination of STARS developed by Mckeon et al. is planned for the STARS group. The training will be given for 6 weeks, 3 times a week for 5 minutes. STARS includes; joint mobilization, plantar massage and triceps surae stretching.

Other: STARS (Sensory-Targeted Ankle Rehabilitation Strategies)

Combined Training

EXPERIMENTAL

Each participant in the combined training program will receive 4 weeks of balance training after 2 weeks of STARS treatment. STARS and hop to stabilization treatment protocol will be applied in the same way.

Other: ExerciseOther: STARS (Sensory-Targeted Ankle Rehabilitation Strategies)

Interventions

The training will be given for 6 weeks, 3 times a week for 20 minutes. This phased balance training program is based on the participant's ability to maintain a single limb posture while performing balance activities. The program includes: 1) hop to stabilization, 2) hop to stabilization and reach, 3) hop to stabilization box drill, 4) progressive single-limb stance balance activities with eyes open, and 5) progressive single-limb stance activities with eyes closed. Participants will be followed up with a physiotherapist and will be able to proceed to the next stage of the test after completing the previous level without errors.

Balance training:Combined Training

STARS includes; joint mobilization, plantar massage and triceps surae stretching. The training will be given for 6 weeks, 3 times a week for 5 minutes.

Combined TrainingSTARS

Eligibility Criteria

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

You may qualify if:

  • History of first ankle sprain more than 1 year ago
  • Having at least 2 "give away" episodes in the last 6 months
  • Identification of Functional Ankle Instability's score above 11
  • age range
  • Foot and Ankle Ability Measure (FAAM), the score of which is less than %90
  • Foot and Ankle Ability Measure Sports scale (FAAM-S), the score of which is less than %80

You may not qualify if:

  • History of lower extremity surgery
  • History of disease that may affect sensorimotor function in the lower extremity
  • Musculoskeletal disorders that may affect balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir University

Beşiktaş, Istanbul, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

KinesiophobiaAnkle Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pelin Pişirici, PhD, PT

    Bahçeşehir University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department

    STUDY CHAIR
  • Serkan Uzlaşır, PhD, PT

    Nevsehir Haci Bektas Unıversity, Faculty of Sports Sciences, Department of Coaching Education

    STUDY DIRECTOR
  • Aynur Merve Zümre, PT

    Bahçeşehir University, Graduate Education Institute, Physical Therapy and Rehabilitation Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The physiotherapist who made the evaluations will be blind to the groups. He will not know which treatment method will be applied to the participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants between the ages of 18-25, diagnosed with chronic ankle sprain who met the inclusion criteria will be included in the study. Sample size of the study is calculated as 21. All evaluations of the participants, including postural control, weight bearing dorsiflexion angle measurement, function and kinesiophobia will be made by the same physiotherapist. The physiotherapist who made the evaluations will not know which treatment method will be applied to the participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 2, 2022

Study Start

November 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 30, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations