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

Comparison of the effects of foot orthoses and exercise program in improving gait, balance and ankle muscle properties in patients after tibial pilon fracture surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230813059137N1
Enrollment
36
Registered
2023-08-28
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Intervention 1: Intervention group 1: that will wear foot orthoses in addition to physical exercise. Intervention 2: Intervention group 2: will only perform physical exercise training.

Sponsors

“Victor Babes” University of Medicine and Pharmacy Timisoara, Romania
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Romania

Contacts

Public ContactAndrei-Daniel Bolovan

"Victor Babes” University of Medicine and Pharmacy Timisoara, Romania

andrei.bolovan@umft.ro+40 256 204 250

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026