Chronic ankle instability, ankle pain
Conditions
Interventions
Control group:Classic rehabilitation plan
Experimental group:New rehabilitation plan
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Comply with the trial process and voluntarily sign the informed consent form; 2. Male or female subjects between the ages of 18 and 50 years (inclusive) at screening; 3. The diagnostic criteria were carried out in accordance with the "Expert Consensus on the Surgical Treatment of Chronic Lateral Ankle Instability" published by the Chinese Medical Journal in 2021. At the screening period and baseline, there are clinical symptoms of chronic ankle instability, defined as: history of recurrent ankle sprains/ankle pain after exercise and exertion/radiographically confirmed lateral ankle ligaments (including anterior talofibular ligament and calcaneofibular ligament) with poor continuity and poor tone; 4. No systematic rehabilitation therapy for chronic ankle instability has been carried out before screening. (Definition of systemic rehabilitation: includes ankle balance training, continuous peroneal tendon function exercises, Achilles tendon and calf triceps strengthening exercises, BAPS balance training, and ankle-specific interference training.) Receive more than 1 of the above rehabilitation trainings and persist for more than 6 weeks); 5. The patient was an exercise population, and the Tegner exercise score was >=5 points; 6. If it is a female subject, it should be a postmenopausal or surgically sterilized or negative blood pregnancy test during the screening period and a female of childbearing age who agrees to use contraception during rehabilitation.
Exclusion criteria
Exclusion criteria: 1.According to subject records or medical records, the affected ankle joint has undergone previous surgical treatment or systematic rehabilitation therapy; 2.The proposed subject has poor ankle and hind foot joint force lines and osteoarthritis; 3.Both lower limbs have a history of fractures, ligament ruptures, joint injuries, etc. that have not been cured, and there are clinical sequelae; 4.There is no plan to return to sports afterwards; 5.Previously existing any other neuromuscular diseases, physical examination results, or clinical laboratory test results indicating reasonable suspicion of contraindications to rehabilitation therapy, or diseases or conditions that affect the interpretation of research results, or put subjects at risk of treatment (including but not limited to: generalized allergic dermatitis, myasthenia gravis, Chacot Marie Tooth disease, systemic multiple ligament laxity, etc.); 6.Researchers believe that due to other reasons, participants are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankle joint function score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical indicators;Recurrence rate of ankle sprain;Safety; | — |
Countries
China
Contacts
Public ContactBai Lu
Peking University Shenzhen Hospital
Outcome results
None listed