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

Ankle Sprains Clinical Trial

— ANKLE-PRO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05868681
• Other study ID #: 0012824
• Status: Completed
• Phase: N/A
• Start date: February 12, 2018
• Est. completion date: February 12, 2019

Study information

• Verified date: April 2020
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 12, 2019
• Est. primary completion date: February 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Injuries
• Ankle Sprains
• Instability, Joint
• Joint Instability

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	Rizzoli Orthopedic Institute (IOR)	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Personal perception of the patient	Subjective perception of the patient evaluated by administering clinical questionnaires (AOFAS ankle hindfoot)	5 weeks from the start of rehabilitation treatment
Secondary	Clinical test	Stability of the ankle operated evaluated by clinical test	5 weeks from the start of rehabilitation treatment