Back to resultsEvaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability (ANKLE-PRO)
Primary Purpose
Ankle Sprains, Instability, Joint
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Delos instrument (computerized balance board)
Sponsored by
About this trial
This is an interventional diagnostic trial for Ankle Sprains focused on measuring Ankle instability, Stabilometry
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.
Sites / Locations
- Rizzoli Orthopedic Institute (IOR)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Study group
Control group
Arm Description
Proprioceptive training, which will be carried out 1 session lasting one hour twice per week for 5 weeks using Delos instrument with Riva method
Normal physiotherapy performed according to standard protocols.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Personal perception of the patient
Subjective perception of the patient evaluated by administering clinical questionnaires (AOFAS ankle hindfoot)
Clinical test
Stability of the ankle operated evaluated by clinical test
Full Information
NCT ID
NCT05868681
First Posted
April 12, 2018
Last Updated
May 19, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT05868681
Brief Title
Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability
Acronym
ANKLE-PRO
Official Title
Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
February 12, 2019 (Actual)
Study Completion Date
February 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Sprains, Instability, Joint
Keywords
Ankle instability, Stabilometry
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
Proprioceptive training, which will be carried out 1 session lasting one hour twice per week for 5 weeks using Delos instrument with Riva method
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Normal physiotherapy performed according to standard protocols.
Intervention Type
Device
Intervention Name(s)
Delos instrument (computerized balance board)
Intervention Description
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 Outcome Measure Information:
Title
Static and Dynamic Stability Index
Description
Evaluation of proprioception and mechanical stability of the post-operative ankle undergoing to reconditioning with a Delos device through Static and Dynamic Stability Index.
Time Frame
5 weeks from the start of rehabilitation treatment
Secondary Outcome Measure Information:
Title
Personal perception of the patient
Description
Subjective perception of the patient evaluated by administering clinical questionnaires (AOFAS ankle hindfoot)
Time Frame
5 weeks from the start of rehabilitation treatment
Title
Clinical test
Description
Stability of the ankle operated evaluated by clinical test
Time Frame
5 weeks from the start of rehabilitation treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rizzoli Orthopedic Institute (IOR)
City
Bologna
ZIP/Postal Code
40136
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability
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