Clinical Trials Directory

Trials / Completed

CompletedNCT05202873

Analysis of Spatiotemporal Gait Parameters in Patients With Megaprosthesis.

Comparative Analysis of Spatiotemporal Gait Parameters in Patients With Distal Femoral Megaprosthesis and Healthy Subjects Using an Inertial Measurement Unit (IMU)

Status
Completed
Phase
Study type
Observational
Enrollment
79 (actual)
Sponsor
Cardenal Herrera University · Academic / Other
Sex
All
Age
16 Years – 99 Years
Healthy volunteers
Accepted

Summary

The main objective of the study is to evaluate spatiotemporal parameters of gait in tumoral patients with megaprosthesis of the distal femur.

Detailed description

Patients with distal femoral prostheses treated at La Fe Hospital in Valencia were evaluated and compared with healthy controls. A radiographic study was conducted in cases using telemetric imaging to assess the percentage of remaining bone and the long length limb discrepancy following surgical intervention. Additionally, a gait analysis was performed using the BTS device to obtain objective gait parameters. The gait assessment was conducted with a non-invasive portable device, the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy), which was placed at the S1 level to collect spatio-temporal gait data. The data were analyzed in relation to the values in healthy patients.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTGait analysisGait assessment will be performed using a non-invasive device. It is the BTS G-sensor inertial sensor (BTS Bioengineering, Garbagnate Milanese, Italy). The spatiotemporal variables of gait will be studied from the Walk+ protocol, in which the participant navigates a 7-meter hallway six times, completing three round trips with necessary turns at each end to change direction.

Timeline

Start date
2018-02-08
Primary completion
2024-11-01
Completion
2024-11-01
First posted
2022-01-24
Last updated
2024-12-11

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05202873. Inclusion in this directory is not an endorsement.