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OpenTrials
Completed

NCT Number: NCT05868681

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rizzoli Orthopedic Institute (IOR)

Bologna, 40136, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Static and Dynamic Stability Index

    Time frame: 5 weeks from the start of rehabilitation treatment

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

Secondary outcomes

  1. Personal perception of the patient

    Time frame: 5 weeks from the start of rehabilitation treatment

    Subjective perception of the patient evaluated by administering clinical questionnaires (AOFAS ankle hindfoot)

  2. Clinical test

    Time frame: 5 weeks from the start of rehabilitation treatment

    Stability of the ankle operated evaluated by clinical test

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: ANKLE-PRO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 22, 2023
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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