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临床试验/NCT03818438
NCT03818438终止不适用

Biomechanical Analysis, Complementary Examinations and Rehabilitative Management of Chronic Ankle Instability

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
4
试验地点
1
主要终点
the Star Excursion Balance Test (SEBT)

研究概览

简要总结

Chronic ankle instability is a common condition in the active adult population and characterized by the occurrence of repeated giving way and/or recurrent ankle sprains. Multiple underlying deficits have been proposed, among which ankle muscle strength deficits, proprioception deficits, ( static and dynamic balance disorders, and articular laxity. Unfortunately, no consensus exists on which clinical tests should be realized to determine if one of these underlying deficits is predominant and as a result could guide the rehabilitation process. The study hypothesis is that people with chronic ankle instability might be heterogenous and could be divided in different subgroups as a function of underlying deficits. Therefore, this study aims to evaluate the capacity of different clinical tests to differentiate people with chronic ankle instability from healthy people as well as between each other.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Case subject : at least one initial lateral ankle sprain more than 12 months before inclusion
  • Case subject : at least one residual symptom among (1) giving way, (2) sensation of instability, (3) recurrent ankle sprain. This item is confirmed by a score inferior than 24 on the Chronic Ankle Instability Tool (CAIT)
  • Case subject : Impact on activities of daily living and sport, confirmed by a score of less than 90% on the Foot and Ankle Ability Measure (FAAM) and less than 80% on FAAM-- - -- Control subject : matched by age and sex to case subjects

排除标准

  • Surgery of one of the lower limbs less than 3 years ago
  • Presence of heavy pain (EVA > 8) regardless of its origin
  • Acute lateral ankle sprain less than 4 months before inclusion
  • Neurological disorders of any kind
  • Medical treatment (drugs) interfering with muscle tone, balance and proprioception disorders
  • Pregnant or breastfeeding women
  • Body mass index > 30
  • Bilateral chronic ankle instability

结局指标

主要结局

the Star Excursion Balance Test (SEBT)

时间窗: Baseline

Dynamic balance test : SEBT (both ankles tested) : are composite measure * Distance reached in anterior direction (% leg length) * Distance reached in posteromedial direction (% leg length) * Distance reached in posterolateral direction (% leg length) * Time used to reach (s) * COP displacement (mm) * COP velocity (s) * COP area (mm²) * COP time-to-boundary (TTB) (s)

Static balance tests

时间窗: Baseline

Static balance tests ( DLS and SLS (both ankles tested) ; Stabilometry) are composite measure * Centre of Pressure (COP) displacement (mm) ; * COP velocity (mm/s) * COP area (mm²) * COP time-to-boundary (TTB) (s) * Number of foot lifts (integer)

Strength tests (both ankles tested)

时间窗: Baseline

Isokinetic strength tests (both ankles tested) : * Plantar flexor peak torque (Nm) * Dorsiflexor peak torque (Nm) * Inversion peak torque (Nm) * Eversion Peak torque (Nm)

Hop tests

时间窗: Baseline

Hop tests (both ankles tested) : SLHD et SH ; are composite measure * Distance reached (m) * Max inversion angle ankle joint (°) * Max internal rotation angle ankle joint (°) * Max vertical Ground Reaction Force (GRF) at landing (N) * Max lateral GRF (N) * Time used to complete 10 hops (s)

次要结局

  • Intra-class correlation coefficients (reproducibility test-retest)(Baseline and 1-4 weeks after baseline)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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