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Not yet recruiting NCT07051018

Radiological and Clinical Measures as Predictors of Dynamic Postural Control Deficits in Chronic Ankle Instability

Observational Chronic Ankle Instability, CAI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Ankle Instability, CAI. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The purpose of this study is to investigate the association between dynamic postural control and clinical measures of (ankle and hip strength, ankle DFROM and position sense) and radiological measures in patients with unilateral CAI.

Detailed description

Ankle sprains are among the most frequent injuries seen in emergency departments and in sports injury clinics. Among all ankle injuries, ankle sprains are the most common and account for approximately 80% of which 77% are lateral sprains. Ankle sprain incidence ranges from 5.3- 7.0 sprained ankles per one thousand persons per year in Europe and is estimated to be 23,000 ankle sprains occur per day in the United States. Up to 74% of individuals who sprained their ankle experience ongoing problems that prevent them from participating in sports and other physical activities. Lateral ankle sprain (LAS) typically occurs when the rear foot is supinated, and the leg is externally rotated. Inversion injuries affect the lateral ankle ligaments and subtalar ligaments concomitantly; around 73% of lateral ankle sprains are due to rupture or tear of the Anterior Talo-Fibular Ligament (ATFL), followed by Calcaneo Fibular Ligament (CFL) and cervical ligament of the subtalar joint with the interosseous talocalcaneal ligament respectively.

HYPOTHESES:

It will be hypothesized that:

1. There will be no relation between the radiological measures of the ankle joint and dynamic postural control in patients with unilateral CAI. 2. There will be no relation between hip muscles strength and dynamic postural control in patients with unilateral CAI. 3. There will be no relation between ankle performance (muscle strength, DFROM and position sense) and dynamic postural control in patients with unilateral CAI. 4. There will be a non-significant difference in the dynamic postural control between affected and normal lower limb. 5. There will be a non-significant difference in the radiological measures between affected and normal lower limb. 6. There will be a non-significant difference in the ankle performance between affected and normal lower limb. 7. There will be a non-significant difference in the muscle strength around the hip joint between the affected and normal lower limb.

Primary outcome measures

  • Y- balance test [Time frame: baseline]
Secondary outcome measures (1)
  • Radiographic measurements validated for non weight bearing radiographs (Talocrural Angle and Talar Tilt) [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • Participants will be screened for eligibility and only those who meet the inclusion criteria according to Delahunt et al. (2010) and Gribble et al. (2013) will be enrolled in our study, i.e., they will participate if they have:
  • At least one significant unilateral lateral ankle sprain in which the subject was unable to walk independently without the aid of crutches (the first sprain occurred more than 12 months ago).
  • Repeated bouts of lateral ankle injury (last injury had to be more than three months prior to inclusion in the study).
  • Feeling of ankle instability "giving way", at least 2 episodes in the last 6 months (Terada et al., 2014).
  • Pain during intense loading.
  • The Cumberland Ankle Instability Tool (CAIT) ≤ 24.
  • Age range of 18-30 years (Delahunt et al., 2010).

Exclusion criteria

  • \*Patients will be excluded if they didn't meet the inclusion criteria mentioned above, such as:
  • A previous trauma or surgery to the trunk or lower extremities other than an ankle sprain.
  • Neurological or vestibular impairments with remaining deficits.
  • No participant with CAI had acutely sprained his or her ankle in the 3 months prior to the testing.
  • Participants will be excluded if they have participated in any rehabilitation in the past 6 months.
  • Concussion or head injury or lower back pain in the past 6 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07051018 · P.T.REC/012/005628

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗