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

NCT ID: NCT05868681

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-12
• Study Completion Date: 2019-02-12

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.

Conditions

Ankle Sprains; Instability, Joint

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Study group

Proprioceptive training, which will be carried out 1 session lasting one hour twice per week for 5 weeks using Delos instrument with Riva method

Group Type: EXPERIMENTAL

Delos instrument (computerized balance board)

Intervention Type: DEVICE

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.

Control group

Normal physiotherapy performed according to standard protocols.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Delos 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rizzoli Orthopedic Institute (IOR)

Bologna, , Italy

Countries

Italy

Other Identifiers

0012824

Identifier Type: -

Identifier Source: org_study_id