NCT07376915

Brief Summary

The primary aim of this study is to evaluate the immediate and short-term effects of the Graded Motor Imagery (GMI) method on individuals with chronic ankle instability (CAI). In this context, the effects of the Graded Motor Imagery intervention on pain level, muscle stiffness, muscle strength, functional performance, and subjective instability level will be investigated. Additionally, these effects will be comparatively analyzed with an age- and sex-matched control group consisting of healthy individuals.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

December 17, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2026

Completed
Last Updated

February 11, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

December 17, 2025

Last Update Submit

February 9, 2026

Conditions

Ankle InstabilityHealthy Controls

Outcome Measures

Primary Outcomes (4)

  • Subjective Instability (CAIT)

    A valid-reliable questionnaire that questions the perceived instability in daily life and sports activities. Clinical Significance: ≥ 3 point increase is considered clinically significant

    baseline

  • Subjective Instability (CAIT)

    A valid-reliable questionnaire that questions the perceived instability in daily life and sports activities. Clinical Significance: ≥ 3 point increase is considered clinically significant

    1-week post-intervention

  • Ground Reaction Force & Static Balance (ForceDecks)

    Device: ForceDecks dual force platform. 1. Single-Leg Jump Test\* Values: Net vertical ground reaction force (N·kg-¹), flight time (ms), asymmetry (%). 2. Single-Leg Static Balance\* Values: Total sway path (mm), ellipse area (mm²). Clinical Importance:\* Captures short-term changes in neuromuscular control and explosive strength in a detailed manner.

    baseline

  • Ground Reaction Force & Static Balance (ForceDecks)

    Device: ForceDecks dual force platform. 1. Single-Leg Jump Test\* Values: Net vertical ground reaction force (N·kg-¹), flight time (ms), asymmetry (%). 2. Single-Leg Static Balance\* Values: Total sway path (mm), ellipse area (mm²). Clinical Importance:\* Captures short-term changes in neuromuscular control and explosive strength in a detailed manner.

    1-week post-intervention

Secondary Outcomes (8)

  • Muscle Stiffness (Myoton PRO)

    baseline

  • Muscle Stiffness (Myoton PRO)

    1-week post-intervention

  • Muscle Strength Assessment - Isokinetic dynamometer (Isoforce)

    baseline

  • Muscle Strength Assessment - Isokinetic dynamometer (Isoforce)

    1-week post-intervention

  • Pain Level

    baseline

  • +3 more secondary outcomes

Study Arms (2)

instability group

EXPERIMENTAL
Other: graded motor imagery

control group

ACTIVE COMPARATOR
Other: graded motor imagery

Interventions

graded motor imageryOTHER

The Graded Motor Imagery (GMI) program will be applied six consecutive days nd will consist of three progressive stages: Laterality Training: Participants will perform right-left ankle discrimination tasks using validated foot and ankle images. Accuracy and response time will be recorded. Motor Imagery: Participants will mentally rehearse ankle movements such as dorsiflexion, plantarflexion, inversion, and eversion without performing the motion. Imagery tasks will progress from simple movements to functional patterns based on tolerance. Mirror Therapy: A mirror will be placed in the midsagittal plane, allowing participants to view the reflection of the non-affected ankle while performing movements. The visual illusion of normal movement is intended to improve motor control and proprioception.

control groupinstability group

Eligibility Criteria

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

You may qualify if:

  • Aged between 18 and 40 years.
  • Diagnosed with chronic ankle instability (CAIT ≤ 24).
  • History of an acute ankle sprain occurring more than 3 months prior to enrollment.
  • Has not received ankle rehabilitation treatment.
  • Voluntarily participated in this study

You may not qualify if:

  • Vestibular or neurological disorders
  • Other lower extremity injuries
  • History of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul Üniversitesi-Cerrahpaşa

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • Kim KM, Estepa-Galego A, Estudilo-Martínez MD, Castelote-Cabalero Y, Cruz-Díaz D. Comparative Effects of Neuromuscular- and Strength-Training Protocols on Pathomechanical, Sensory-Perceptual, and Motor-Behavioral Impairments in Patients with Chronic Ankle Instability: Randomized Contro led Trial. Healthcare (Basel). 2022 Jul 22;10(8):1364. doi: 10.3390/healthcare10081364. PMID: 35893186; PMCID: PMC9394255.

    BACKGROUND

  • Naderi A, Ahi K. Comparative analysis of land-based vs. water-based balance training on quality of life and physical and psychological deficits in athletes with chronic ankle instability: a randomized contro led trial. BMC Sports Sci Med Rehabil. 2025 Jan 20;17(1):9. doi: 10.1186/s13102-024-01049-3. PMID: 39828772; PMCID: PMC11744859.

    BACKGROUND

  • David P, Halimi M, Mora I, Doutrelot PL, Petitjean M. Isokinetic testing of evertor and invertor muscles in patients with chronic ankle instability. J Appl Biomech. 2013 Dec;29(6):696-704. doi: 10.1123/jab.29.6.696. Epub 2013 Jan 18. PMID: 23343782.

    BACKGROUND

  • Wright CJ, Linens SW, Cain MS. Establishing the Minimal Clinical Important Difference and Minimal Detectable Change for the Cumberland Ankle Instability Tool. Arch Phys Med Rehabil. 2017 Sep;98(9):1806-1811. doi: 10.1016/j.apmr.2017.01.003.

    BACKGROUND

  • Moseley GL. Graded motor imagery for pathologic pain: a randomized controled trial. Neurology. 2006 Dec 26;67(12):2129 34. doi: 10.1212/01.wnl.0000249112.56935.32. Epub 2006 Nov 2. PMID: 17082465.

    BACKGROUND

Study Officials

  • SEZEN KARABÖRKLÜ ARGUT, Assistant Professor, PhD

    Istanbul University-Cerrahpaşa, Faculty of Health Sciences

    STUDY DIRECTOR

Central Study Contacts

SEDA ATEŞ, Bachelor degree

CONTACT

90+ 5388543087seda.ates@ogr.iuc.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

December 17, 2025

First Posted

January 29, 2026

Study Start

February 9, 2026

Primary Completion

June 9, 2026

Study Completion

June 9, 2026

Last Updated

February 11, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)