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

NCT05868681 | Completed

• 1 other identifier: 0012824
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Sprains; Instability, Joint

Keywords

Ankle instability; Stabilometry

Outcome Measures

Primary Outcomes (1)

• Static and Dynamic Stability Index

  Evaluation of proprioception and mechanical stability of the post-operative ankle undergoing to reconditioning with a Delos device through Static and Dynamic Stability Index.

  5 weeks from the start of rehabilitation treatment

Secondary Outcomes (2)

• Personal perception of the patient

  5 weeks from the start of rehabilitation treatment

• Clinical test

  5 weeks from the start of rehabilitation treatment

Study Arms (2)

Study group

EXPERIMENTAL

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

Device: Delos instrument (computerized balance board)

Control group

NO INTERVENTION

Normal physiotherapy performed according to standard protocols.

Interventions

Delos instrument (computerized balance board) 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.

Study group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Rizzoli Orthopedic Institute (IOR)

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Ankle Injuries; Joint Instability

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 22, 2023
• Study Start: February 12, 2018
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: May 22, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)