S93.4
Conditions
Interventions
Group 1: Control group: Patients with acute lateral ankle sprain receive functional non-operative standard rehabilitation including bracing and early physiotherapy. No additional intervention using th
Sponsors
Medizinische Fakultät OWL, Universität Bielefeld
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: Physically active adults aged 18 to 35 years are eligible for inclusion. For the patient groups, additional inclusion criteria are: acute lateral ankle sprain with a conservatively treatable lateral ligament injury, inclusion within 7–10 days after injury, physical activity before injury, and ability to provide informed consent. For the healthy comparison cohort, additional inclusion criteria are: no acute ankle injury, no relevant musculoskeletal pre-existing conditions, no pain at rest, and physical activity.
Exclusion criteria
Exclusion criteria: Exclusion criteria are injuries requiring surgical treatment, in particular open injuries, relevant osteochondral fractures or other severe concomitant injuries, previous relevant injuries or surgery of the affected ankle, chronic musculoskeletal disorders, relevant neurological or internal medical conditions, regular medication with a potential influence on training or outcomes, inability to provide informed consent, and lack of willingness or ability to attend the scheduled assessment and training appointments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ankle-specific function from T0 to T1, assessed using the German version of the Foot and Ankle Outcome Score (FAOS). T0 is defined as the start of rehabilitation or assessment within 7–10 days after injury; T1 is defined as the end of the structured rehabilitation phase. Data are collected using a standardized questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes include pain intensity assessed by a numerical rating scale (NRS), general health-related quality of life assessed by EQ-5D-5L, perceived ankle instability assessed by the Cumberland Ankle Instability Tool (CAIT), return-to-sport readiness assessed by the ALR-RSI, and objective functional parameters obtained with the Huber 360 system. Objective parameters include balance, stability, coordination, mobility, and strength. Outcomes are assessed at T0, T1, and at approximately six months of follow-up. In addition, adherence, training dose, reasons for discontinuation, and adverse events are documented. | — |
Countries
Germany
Contacts
Public ContactSimon Stumpf
Universitätsklinik für Unfallchirurgie und Orthopädie, Evangelisches Klinikum Bethel
Outcome results
None listed