Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for CAI

July 4, 2021 updated by: Peking University Third Hospital

Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for Chronic Ankle Instability

The objective of this study was to compare the difference of plantar pressure distribution between surgical treatment and conservative treatment for CAI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The data of 20 patients who underwent surgery after reconstruction of the lateral collateral ligament of the ankle joint and 20 patients who underwent balance rehabilitation training were analyzed to compare the clinical effects of surgical treatment and conservative treatment for chronic ankle instability, in order to better guide the selection of the optimal intervention program for patients with chronic ankle joint.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking University Third Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From April 1, 2019, information of 20 patients diagnosed with CAI that underwent surgical treatment in our institute and 20 patients that underwent conservative treatment was collected and evaluated.

Description

Inclusion Criteria:

  • Patients diagnosed with CAI
  • The contralateral ankle joint is healthy

Exclusion Criteria:

  • Accompanied by other musculoskeletal injuries

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
surgical treatment
Patients with CAI undergoing surgical treatment
Procedure: surgical treatment
Anatomical contraction and termination reconstruction of the lateral ligament
conservative treatment
Patients with CAI undergoing conservative treatment
Procedure: conservative treatment
Rehabilitation intervention training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FAAM
Time Frame: pre-surgery, one year after sugery
Foot and Ankle Ability Measure Activity
pre-surgery, one year after sugery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IDFAI
Time Frame: pre-surgery, one year after sugery
Identification of Functional Ankle Instability questionnaire
pre-surgery, one year after sugery
Ligament injury by MRI
Time Frame: pre-surgery, one year after sugery
To evaluate the condition of lateral collateral ligament using magnetic resonance imaging
pre-surgery, one year after sugery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Investigators

  • Study Chair: Yuelin Hu, bachelor, Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 4, 2021

First Posted (Actual)

July 14, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2021

Last Update Submitted That Met QC Criteria

July 4, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • M2019164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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