Ankle InstabilityNCT07376915
Acute Effect of Graded Motor Imagery on Ankle Rehabilitation: A Pilot Study
A study testing graded motor imagery in people with Ankle Instability and Healthy Controls, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankle Instability, Healthy Controls
- What is being tested?
- graded motor imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Feb 2026to 9 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Vestibular or neurological disorders
- Other lower extremity injuries
- History of surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Üniversitesi-Cerrahpaşa
Istanbul
About this study
Official title: The Acute Effect of Graded Motor Imagery-Based Mental Preparation on Ankle Rehabilitation: A Pilot Clinical Study
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.
- Conditions
- Ankle Instability, Healthy Controls
- Being tested
- graded motor imagery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| instability group | Experimental | Not described Receives: Other: graded motor imagery |
| control group | Active comparator | Not described Receives: Other: graded motor imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1-week post-intervention
Ground Reaction Force & Static Balance (ForceDecks)
Device: ForceDecks dual force platform.
- Single-Leg Jump Test* Values: Net vertical ground reaction force (N·kg-¹), flight time (ms), asymmetry (%).
- 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.
Measured: baseline
Ground Reaction Force & Static Balance (ForceDecks)
Device: ForceDecks dual force platform.
- Single-Leg Jump Test* Values: Net vertical ground reaction force (N·kg-¹), flight time (ms), asymmetry (%).
- 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.
Measured: 1-week post-intervention
Secondary outcomes (8)
Muscle Stiffness (Myoton PRO)
Tonic stiffness (N·m-¹) reflects the passive mechanical properties of muscle tissue. The device applies a 0.4 N mechanical impulse to the skin and records the resulting tissue oscillation response. In this study, data will be recorded as the average of 3 impulses.
Clinical Importance: Acute changes in stiffness are considered an indirect indicator of neuroplastic responses in proprioception and motor control.
Measured: baseline
Muscle Stiffness (Myoton PRO)
Tonic stiffness (N·m-¹) reflects the passive mechanical properties of muscle tissue. The device applies a 0.4 N mechanical impulse to the skin and records the resulting tissue oscillation response. In this study, data will be recorded as the average of 3 impulses.
Clinical Importance: Acute changes in stiffness are considered an indirect indicator of neuroplastic responses in proprioception and motor control.
Measured: 1-week post-intervention
Muscle Strength Assessment - Isokinetic dynamometer (Isoforce)
Parameter: Concentric inversion-eversion peak torque (Nm) at 60°·s-¹ Objectively measures agonist-antagonist muscle performance around the ankle joint.
Clinical Significance:* Improvements in strength contribute to functional stability and a reduced risk of re-injury.
Measured: baseline
Muscle Strength Assessment - Isokinetic dynamometer (Isoforce)
Parameter: Concentric inversion-eversion peak torque (Nm) at 60°·s-¹ Objectively measures agonist-antagonist muscle performance around the ankle joint.
Clinical Significance:* Improvements in strength contribute to functional stability and a reduced risk of re-injury.
Measured: 1-week post-intervention
Pain Level
Visual Analog Scale (VAS, 0-10 cm): 0 = "no pain," 10 = "unbearable pain"; the participant marks the scale before and after the session.
Measured: baseline
Pain Level
Visual Analog Scale (VAS, 0-10 cm): 0 = "no pain," 10 = "unbearable pain"; the participant marks the scale before and after the session.
Measured: 1-week post-intervention
Functional Performance
Star Excursion Balance Test (SEBT) Parameter: Normalized reach distance in three primary directions (anteromedial, medial, posteromedial), expressed as a percentage of leg length.
Clinical Significance: Assesses dynamic balance and lateral load-transfer capacity; asymmetries in individuals with chronic ankle instability (CAI) may serve as prognostic indicators.
Measured: baseline
Functional Performance
Star Excursion Balance Test (SEBT) Parameter: Normalized reach distance in three primary directions (anteromedial, medial, posteromedial), expressed as a percentage of leg length.
Clinical Significance: Assesses dynamic balance and lateral load-transfer capacity; asymmetries in individuals with chronic ankle instability (CAI) may serve as prognostic indicators.
Measured: 1-week post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start9 Feb 2026
- Primary completion9 Jun 2026 (estimated)
- Study completion9 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ankle InstabilityStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Ateş, Istanbul University - Cerrahpasa
- Investigators
- SEZEN KARABÖRKLÜ ARGUT, Assistant Professor, PhD, Study director, Istanbul University-Cerrahpaşa, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376915
- Sponsor's protocol ID
- 2025/377
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim KM, Estepa-Gallego A, Estudillo-Martinez MD, Castellote-Caballero Y, Cruz-Diaz D. Comparative Effects of Neuromuscular- and Strength-Training Protocols on Pathomechanical, Sensory-Perceptual, and Motor-Behavioral Impairments in Patients with Chronic Ankle Instability: Randomized Controlled Trial. Healthcare (Basel). 2022 Jul 22;10(8):1364. doi: 10.3390/healthcare10081364.
PubMed 35893186Naderi 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 controlled trial. BMC Sports Sci Med Rehabil. 2025 Jan 20;17(1):9. doi: 10.1186/s13102-024-01049-3.
PubMed 39828772David P, Halimi M, Mora I, Doutrellot 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.
PubMed 23343782Wright 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. Epub 2017 Jan 27.
PubMed 28137476Moseley GL. Graded motor imagery for pathologic pain: a randomized controlled trial. Neurology. 2006 Dec 26;67(12):2129-34. doi: 10.1212/01.wnl.0000249112.56935.32. Epub 2006 Nov 2.
PubMed 17082465
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Graded Motor Imagery-Based Mental Preparation on Ankle Rehabilitation: A Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT07376915
- Acronym / sponsor ID
- 2025/377
- Conditions
- Ankle Instability, Healthy Controls
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 9 Jun 2026 (estimated)
- Study completion
- 9 Jun 2026 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| instability group | Experimental | Other: graded motor imagery |
| control group | Active comparator | Other: graded motor imagery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Vestibular or neurological disorders
- Other lower extremity injuries
- History of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| graded motor imageryThe 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. | Other | control group, instability group |
Primary outcome
Subjective Instability (CAIT)
Time frame: baseline
A valid-reliable questionnaire that questions the perceived instability in daily life and sports activities. Clinical Significance: ≥ 3 point increase is considered clinically significant
Subjective Instability (CAIT)
Time frame: 1-week post-intervention
A valid-reliable questionnaire that questions the perceived instability in daily life and sports activities. Clinical Significance: ≥ 3 point increase is considered clinically significant
Ground Reaction Force & Static Balance (ForceDecks)
Time frame: baseline
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.
Ground Reaction Force & Static Balance (ForceDecks)
Time frame: 1-week post-intervention
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.
8 secondary outcomes
Muscle Stiffness (Myoton PRO)
Time frame: baseline
Muscle Stiffness (Myoton PRO)
Time frame: 1-week post-intervention
Muscle Strength Assessment - Isokinetic dynamometer (Isoforce)
Time frame: baseline
Muscle Strength Assessment - Isokinetic dynamometer (Isoforce)
Time frame: 1-week post-intervention
Pain Level
Time frame: baseline
Pain Level
Time frame: 1-week post-intervention
Functional Performance
Time frame: baseline
Functional Performance
Time frame: 1-week post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Background: PubMed 35893186Kim KM, Estepa-Gallego A, Estudillo-Martinez MD, Castellote-Caballero Y, Cruz-Diaz D. Comparative Effects of Neuromuscular- and Strength-Training Protocols on Pathomechanical, Sensory-Perceptual, and Motor-Behavioral Impairments in Patients with Chronic Ankle Instability: Randomized Controlled Trial. Healthcare (Basel). 2022 Jul 22;10(8):1364. doi: 10.3390/healthcare10081364.
- Background: PubMed 39828772Naderi 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 controlled trial. BMC Sports Sci Med Rehabil. 2025 Jan 20;17(1):9. doi: 10.1186/s13102-024-01049-3.
- Background: PubMed 23343782David P, Halimi M, Mora I, Doutrellot 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.
- Background: PubMed 28137476Wright 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. Epub 2017 Jan 27.
- Background: PubMed 17082465Moseley GL. Graded motor imagery for pathologic pain: a randomized controlled trial. Neurology. 2006 Dec 26;67(12):2129-34. doi: 10.1212/01.wnl.0000249112.56935.32. Epub 2006 Nov 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SEZEN KARABÖRKLÜ ARGUT, Assistant Professor, PhD study director
Istanbul University-Cerrahpaşa, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing graded motor imagery in people with Ankle Instability and Healthy Controls, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEDA ATEŞ, Bachelor degree (90+ 5388543087, seda.ates@ogr.iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Instability (CAIT) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07376915, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.