NCT07319403

Brief Summary

Chronic ankle instability refers to a combination of persistent mechanical and functional instability symptoms following an ankle sprain. Along with these symptoms, decreased proprioception, reduced neuromuscular control, poor postural control, limited dorsiflexion range of motion, decreased ankle strength, and altered lower-extremity biomechanics during functional activities are also observed. In addition, individuals with chronic ankle instability have been shown to exhibit limitations in energy transfer across the lower extremity. These symptoms may hinder patients' physical activity levels and athletic performance and negatively affect their quality of life. Since the lower extremity functions as a unit, changes in adaptive strategies at the ankle can lead to kinematic alterations in proximal joints. Although the instability originates at the ankle, higher-level joints are also affected, and it has even been reported that in this population, lower-extremity stability is primarily achieved through the hip joint. While the effectiveness of hip-focused exercises has begun to be investigated in the literature, the superiority of different muscle groups has not yet been compared.

Trial Health

63
Monitor

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
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress56%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

December 21, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2026

Expected
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 21, 2025

Last Update Submit

December 21, 2025

Conditions

Keywords

Ankle InjuriesMuscle StrengthExercise Training

Outcome Measures

Primary Outcomes (1)

  • Cumberland Ankle Instability Tool (CAIT)

    The Cumberland Ankle Instability Tool (CAIT) is a self-reported questionnaire designed to assess the severity of chronic ankle instability. It consists of 9 items evaluating ankle stability during daily and sports-related activities. Scores range from 0 to 30, with lower scores indicating greater perceived ankle instability. An increase in the CAIT score reflects clinical improvement in ankle stability.

    Baseline and after 6 weeks

Secondary Outcomes (7)

  • Functional Ankle Instability Questionnaire

    Baseline and after 6 weeks

  • Hip Muscle Strength

    Baseline and after 6 weeks

  • Side Hop Test

    Baseline and after 6 weeks

  • Step-Down Test

    Baseline and after 6 weeks

  • Y-Balance Test

    Baseline and after 6 weeks

  • +2 more secondary outcomes

Study Arms (3)

Gluteus Maximus

EXPERIMENTAL

Participants with chronic ankle instability will participate in a 6-week hip-focused exercise program emphasizing gluteus maximus activation.

Other: Gluteus Maximus

Gluteus Medius

EXPERIMENTAL

Participants with chronic ankle instability will participate in a 6-week hip-focused exercise program emphasizing gluteus medius activation.

Other: Gluteus Medius

Control

ACTIVE COMPARATOR

Participants with chronic ankle instability will participate in a 6-week exercise program commonly used in the rehabilitation of ankle instability

Other: Control

Interventions

Participants with chronic ankle instability will undergo a 6-week hip-focused strengthening exercise program specifically targeting the gluteus medius muscle. The intervention aims to improve hip muscle strength and lower extremity stability.

Gluteus Medius

Participants with chronic ankle instability will participate in a 6-week hip-focused strengthening exercise program targeting the gluteus maximus muscle. The program aims to enhance hip extension strength and overall lower extremity stability.

Gluteus Maximus
ControlOTHER

Participants with chronic ankle instability will perform a 6-week standard strengthening exercise program commonly used in the rehabilitation of ankle instability, without specific emphasis on targeted hip muscle strengthening.

Control

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Professional athletes aged between 18 and 40 years
  • Participation in sports for at least 3 years
  • History of at least one lateral ankle sprain that occurred at least 12 months prior to enrollment
  • At least two episodes of perceived ankle "giving way" and/or at least two recurrent lateral ankle sprains within the past 6 months, and/or a subjective feeling of ankle instability on the injured side

You may not qualify if:

  • History of lower extremity surgery
  • History of fracture involving the lower extremity
  • Any lower extremity injury within the past 3 months that limited physical activity for more than one day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Çankaya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • İrem Düzgün

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Gülcan Harput

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants with chronic ankle instability will be randomly assigned into three parallel groups: a gluteus medius strengthening group, a gluteus maximus strengthening group, and a control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

December 21, 2025

First Posted

January 6, 2026

Study Start

January 15, 2026

Primary Completion

April 1, 2026

Study Completion (Estimated)

August 4, 2026

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Law on the Protection of Personal Data (LPPD)

Locations