chronic ankle instability
Conditions
Interventions
Smart Insole Group:Insoles continuously monitor the pressure distribution on the soles of the feet during gait and exercise. The accompanying application will display the pressure map and key gait par
(3D printed insole) Control Group:Participants accept 3D printed custom insoles, which have arch support and pressure dispersion functions but no electronic components. Its shape and material are high
Sponsors
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-50 years old (Adult patients must be able to use smartphone applications and cooperate with rehabilitation training); 2. History of ankle sprain: At least one history of severe lateral ankle sprain before enrollment (time from enrollment >=12 months), and the most recent sprain occurred 3 months ago. A "severe" sprain is defined as an acute injury to the lateral ankle ligament, accompanied by pain, swelling and functional impairment, and restricted movement for at least one day; 3. Subjective instability: Self-reported persistent ankle instability and/or repeated "weakness in the legs". Specifically, the patient needs to report at least two instances of ankle weakness or repeated ankle sprains on the same side within the past six months; 4. Functional ankle instability score: Instability is evaluated through a verified ankle instability questionnaire. We will adopt the Cumberland Ankle Instability Scale (CAIT), and require a CAIT score of less than 24 points (out of 30). (Note: Research shows that CAIT11 points or the Ankle Instability Scale (with >=5 "yes" responses) can also be referred to as supplementary criteria; 5. Baseline functional status: The subject must still have functional deficits, such as less than 80% of the physical activity sub-item of the Foot and Ankle Strength Measurement Scale (FAAM) or less than 90% of the activities of daily living sub-item (this criterion is recommended for assessing the severity of chronic ankle instability), to ensure that the patient has room for improvement through intervention; 6. Willingness and Ability: The subjects must be willing to cooperate with the 6-month intervention and follow-up plan, be able to visit the clinic for regular check-ups, complete the designated training as required, and use the smart insoles and mobile phone applications correctly. A compatible smart phone or tablet (or provided by the research party) is required.
Exclusion criteria
Exclusion criteria: 1. Acute injury: Acute ankle injury was present at the time of enrollment, or any significant lower extremity musculoskeletal injury (such as recent sprain, fracture or leg surgery) that significantly affected gait or function within the past 3 months. Patients who experienced ankle sprains within 3 months were excluded to ensure that the study focused on chronic (non-acute) instability and that the subjects had completed initial healing; 2. Previous ankle joint surgery: Has undergone surgery on the affected ankle joint (such as lateral ligament repair) or other major lower limb surgeries. Surgical reconstruction may alter the mechanical and sensory functions of the ankle joint and interfere with the evaluation of intervention effects centered on rehabilitation; 3. History of fractures: The affected limb has experienced fractures that require reduction or internal fixation (excluding simple avulsion fractures without complications). Severe fractures may lead to mechanical instability or arthritis, which goes beyond the typical range of chronic ankle instability; 4. Other vestibular/neurological disorders: Any neurological or vestibular disorders that affect balance (such as peripheral neuropathy, multiple sclerosis), or other conditions that may independently impair gait (such as severe knee osteoarthritis or hip joint disorders). These factors may interfere with the interpretation of the results; 5. Simultaneous intervention is required for bilateral ankle instability: If a patient has bilateral ankle instability, they can still participate in the study (with the side with more severe symptoms as the "target ankle" assessment result), but they must not be excluded just because the contralateral ankle needs intervention measures that conflict with the study protocol. Those who are unable to safely complete rehabilitation training due to bilateral problems will be excluded (case-by-case assessment decision); 6. Medical contraindications: Uncontrolled chronic diseases (such as uncontrolled diabetes that affects foot sensation, rheumatoid arthritis involving the ankle joint, etc.) or sports contraindications (such as severe heart problems). Pregnant women were also excluded because pregnancy might alter ligament laxity and balance ability, and the impact of the device on the fetus was unknown; 7. Allergy or skin problems: Known allergy to insole materials (such as silicone), or severe skin problems on the feet that prevent the device from being worn for a long time; 8. Inability to give informed consent or cooperate: There is cognitive or language impairment that makes it impossible to understand the research instructions or use technical equipment (unless there is a reliable caregiver to assist).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumberland Ankle Instability Tool (CAIT) questionaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Foot and Ankle Ability Measure (FAAM) questionaire;Single leg balance test;Recurrent ankle sprain log;Double cross jump test;Health Survey Questionnaire-36; | — |
Countries
China
Contacts
Public ContactLu Shengdi
Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed