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Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability

Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05868681
Acronym
ANKLE-PRO
Enrollment
11
Registered
2023-05-22
Start date
2018-02-12
Completion date
2019-02-12
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprains, Instability, Joint

Keywords

Ankle instability, Stabilometry

Brief summary

The objective of the study is to evaluate post-operatively the postural control through the Delos system with the Riva method of patients already treated surgically of external capsulo-ligament reconstruction due to ankle instability.

Detailed description

The patients will then be divided into two control groups: one group will undergo reconditioning through the Delos system and one group will undergo standard rehabilitation treatment. Primary outcome: improvement of joint stability and postoperative proprioception after reconditioning with the Delos system. Secondary outcomes: improvement of performance indicators and reduction of disability and satisfaction and assessment of long-term ankle stability after reconditioning with Delos system.

Interventions

DEVICEDelos instrument (computerized balance board)

Proprioceptive training using Delos instrument (computerized balance board). Static and dynamic evaluation through Delos with the Riva method; Physiatric visit; Clinical scores (AOFAs); Functional scores (SPPB); SF12 satisfaction.

Sponsors

Istituto Ortopedico Rizzoli
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* patients already undergoing surgery and with at least 4 months of follow-up; * patients of both sexes aged between 18-40 years; * patients who have given their informed written consent to participate in the study; * patients who have given the willingness to reach the Hospital to carry out the checks.

Exclusion criteria

* patients with BMI\> 30 kg / m2; * patients with rheumatoid arthritis; * patients with chronic inflammatory joint diseases; * patients with pre-existing deambulation kinematics abnormalities (amputations, neuro- muscular diseases, polio, hip dysplasias); * patients with Severe arthrosis of the ankle (Kellgren-Lawrence\> 3); * patients with Severe knee arthritis (Kellgren-Lawrence\> 3); * patients with severe postural instability; * patients with cognitive impairments; * patients with concomitant neurological diseases.

Design outcomes

Primary

MeasureTime frameDescription
Static and Dynamic Stability Index5 weeks from the start of rehabilitation treatmentEvaluation of proprioception and mechanical stability of the post-operative ankle undergoing to reconditioning with a Delos device through Static and Dynamic Stability Index.

Secondary

MeasureTime frameDescription
Personal perception of the patient5 weeks from the start of rehabilitation treatmentSubjective perception of the patient evaluated by administering clinical questionnaires (AOFAS ankle hindfoot)
Clinical test5 weeks from the start of rehabilitation treatmentStability of the ankle operated evaluated by clinical test

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026