- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07376915
Acute Effect of Graded Motor Imagery on Ankle Rehabilitation: A Pilot Study
The Acute Effect of Graded Motor Imagery-Based Mental Preparation on Ankle Rehabilitation: A Pilot Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: SEDA ATEŞ, Bachelor degree
- Phone Number: 90+ 5388543087
- Email: seda.ates@ogr.iuc.edu.tr
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Recruiting
- İstanbul Üniversitesi-Cerrahpaşa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Vestibular or neurological disorders
- Other lower extremity injuries
- History of surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control group
|
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. |
|
Experimental: instability group
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
baseline
|
|
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 |
1-week post-intervention
|
|
Ground Reaction Force & Static Balance (ForceDecks)
Time Frame: baseline
|
Device: ForceDecks dual force platform.
Clinical Importance:* Captures short-term changes in neuromuscular control and explosive strength in a detailed manner. |
baseline
|
|
Ground Reaction Force & Static Balance (ForceDecks)
Time Frame: 1-week post-intervention
|
Device: ForceDecks dual force platform.
Clinical Importance:* Captures short-term changes in neuromuscular control and explosive strength in a detailed manner. |
1-week post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle Stiffness (Myoton PRO)
Time Frame: baseline
|
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. |
baseline
|
|
Muscle Stiffness (Myoton PRO)
Time Frame: 1-week post-intervention
|
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. |
1-week post-intervention
|
|
Muscle Strength Assessment - Isokinetic dynamometer (Isoforce)
Time Frame: baseline
|
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. |
baseline
|
|
Muscle Strength Assessment - Isokinetic dynamometer (Isoforce)
Time Frame: 1-week post-intervention
|
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. |
1-week post-intervention
|
|
Pain Level
Time Frame: baseline
|
Visual Analog Scale (VAS, 0-10 cm): 0 = "no pain," 10 = "unbearable pain"; the participant marks the scale before and after the session.
|
baseline
|
|
Pain Level
Time Frame: 1-week post-intervention
|
Visual Analog Scale (VAS, 0-10 cm): 0 = "no pain," 10 = "unbearable pain"; the participant marks the scale before and after the session.
|
1-week post-intervention
|
|
Functional Performance
Time Frame: baseline
|
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. |
baseline
|
|
Functional Performance
Time Frame: 1-week post-intervention
|
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. |
1-week post-intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: SEZEN KARABÖRKLÜ ARGUT, Assistant Professor, PhD, Istanbul University-Cerrahpasa, Faculty of Health Sciences
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025/377
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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