Comparison of exercise program and foot orthoses versus exercise program in patients after tibial pilon fracture surgery

Phase 3

Recruiting

• Conditions: Condition 1: Fracture of lower end of tibia. Condition 2: Other abnormalities of gait and mobility.; Fracture of lower end of tibia; Other abnormalities of gait and mobility; S82.3; R26.8

• Registration Number: IRCT20230813059137N1
• Lead Sponsor: Victor Babes” University of Medicine and Pharmacy Timisoara, Romania

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

patients must be adults who have undergone surgery for unilateral tibial pilon fracture;
must show clinical and radiological evidence of fracture healing;
must be able to put full weight on the fractured leg;;
must agree to participate voluntarily
healthy contralateral lower leg that can be used as a healthy control;

Exclusion Criteria

history of traumas or fractures in the lower leg with the tibial pilon fracture;
a history of traumas or fractures in the opposite lower leg used as healthy control
any neurological or other health conditions that may cause difficulty in walking or changes in muscle function
lower leg asymmetry not related to the tibial pilon fracture
psychiatric disorders or other disorders that affect compliance

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcomes will be gait, balance, calf muscle properties and muscle strenght. Timepoint: The evaluation of the primary outcome following the application of intervention is after 3 months. Method of measurement: The assessment involves four different testing procedures: myotonometry, muscle strength testing, gait analysis, and double-leg and single-leg balance tests.

Secondary Outcome Measures

Name	Time	Method
The secondary outcomes will be the quality of life and the severity of pain during sports and daily activities. Timepoint: Secondary outcome will be measured 3 months after the application of intervention. Method of measurement: Assessment questionnaires such as Olerud-Molander Ankle Score ( OMAS) and visual analogue scale (VAS) will be used.