Status:
ACTIVE_NOT_RECRUITING
fMRI Study on Cerebral Localization and Network Mechanisms of rTMS in Chronic Ankle Instability Treatment
Lead Sponsor:
Wuhan University
Conditions:
Chronic Ankle Instability, CAI
Functional Magnetic Resonance Imaging (fMRI)
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Chronic ankle instability (CAI) is a common sports injury that often leads to recurrent injuries and functional deficits. While conventional rehabilitation can restore ankle stability, the underlying ...
Eligibility Criteria
Inclusion
- Age 18-60 years.
- History of at least one significant ankle sprain within the past 12 months, accompanied by inflammatory response (including pain resulting in at least one day of restricted physical activity).
- The most recent ankle sprain must have occurred more than 3 months prior to enrollment.
- Self-reported symptoms of ankle instability, defined by one or more of the following: At least two episodes of "giving way" in the affected ankle within the past 6 months; Recurrent sprains (≥2 documented sprains in the same ankle); Subjective perception of instability confirmed by any one of the following validated instruments: Ankle Instability Instrument (AII): ≥5 affirmative responses; Cumberland Ankle Instability Tool (CAIT): Score \<24; Identification of Functional Ankle Instability (IdFAI): Score \>11.
- Foot and Ankle Ability Measure (FAAM): Activities of Daily Living (ADL) subscale \<90%; FAAM Sports subscale \<80%; Foot and Ankle Outcome Score (FAOS): Scores \<75% in ≥3 subcategories.
Exclusion
- Chronic ankle instability caused by bilateral ankle sprains;
- History of lower extremity musculoskeletal or neurological surgery;
- History of lower extremity fractures;
- Acute musculoskeletal injuries in other lower extremity joints within 3 months that compromised joint integrity and function, resulting in ≥1 day of interrupted daily or sports activities;
- Concomitant severe systemic diseases (cardiac, pulmonary, hepatic, renal, etc.);
- Severe psychiatric disorders or cognitive impairments;
- Presence of metal implants or inability to tolerate MRI examinations.
- Patient refusal to participate.
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06971705
Start Date
March 20 2025
End Date
October 31 2026
Last Update
December 18 2025
Active Locations (1)
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1
Zhongnan hospital of Wuhan University
Wuhan, Hubei, China, 430070