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

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ClinicalTrials.gov Identifier: NCT04961892
Recruitment Status : Completed
First Posted : July 14, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

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

Condition or disease Intervention/treatment
Chronic Ankle Instability Procedure: surgical treatment Procedure: conservative 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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Difference of Plantar Pressure Distribution Between Surgical Treatment and Conservative Treatment for Chronic Ankle Instability
Actual Study Start Date : April 1, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : June 1, 2020

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




Primary Outcome Measures :
  1. FAAM [ Time Frame: pre-surgery, one year after sugery ]
    Foot and Ankle Ability Measure Activity


Secondary Outcome Measures :
  1. IDFAI [ Time Frame: pre-surgery, one year after sugery ]
    Identification of Functional Ankle Instability questionnaire

  2. Ligament injury by MRI [ Time Frame: pre-surgery, one year after sugery ]
    To evaluate the condition of lateral collateral ligament using magnetic resonance imaging



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Accompanied by other musculoskeletal injuries

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04961892


Locations
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China
Peking University Third Hospital
Beijing, China
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Chair: Yuelin Hu, bachelor Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04961892    
Other Study ID Numbers: M2019164
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No