Analysis of Spatiotemporal Gait Parameters in Patients With Megaprosthesis. (MP-GP)

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

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

Study Overview

• Status: Completed
• Conditions: Distal Femoral Musculoskeletal Tumors; Megaprosthesis
• Intervention / Treatment: Diagnostic test: Gait analysis

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.

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46006
    • Universidad CEU Cardenal Herrera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent a megaprosthesis of the lower limb (distal femur) at Hospital La Fe by the orthopedic surgery and traumatology service, due to a tumor cause

Description

Inclusion Criteria:

• Megaprosthesis of the distal femur
• Tumor cause
• Surgery at Hospital la Fe.
• Traditional stem or biological ossteointegration system
• Minimum postoperative follow-up period of 3 months

Exclusion Criteria:

• Neurological alterations prior to the intervention that affect the lower limbs or general movement.
• Patient incapable of ambulation due to progression of his/her pathology
• Patient at home with palliative treatment for advanced tumor disease
• Any ipsilateral or contralateral prosthesis.
• Infectious or traumatic cause

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; Healthy subjects	Diagnostic test: Gait analysis; Gait 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.
Cases; Patients with distal femoral megaprosthesis due to musculoskeletal tumor	Diagnostic test: Gait analysis; Gait 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antero-posterior acceleration symmetry index	This metric serves as a quantifiable measure of the symmetry exhibited in movements along the antero-posterior axis, thereby illustrating the equilibrium and coordination inherent in the body's kinetic activities.	3 months
Stance Phase	Refers to the portion of the gait cycle during which a foot is in contact with the ground. It begins with the initial contact (heel strike) and ends when the same foot leaves the ground (toe-off). The stance phase is a critical component of walking and running, contributing to balance, propulsion, and weight-bearing. Measured as a percentage of the total gait cycle, 60% of the cycle in typical walking.	3 months
Swing Phase	Refers to the portion of the gait cycle during which a foot is not in contact with the ground. It begins when the foot lifts off the ground (toe-off) and ends when the same foot makes contact again (heel strike). The swing phase allows the leg to advance forward and position itself for the next step. Measured as a percentage of the total gait cycle, 40% of the cycle in normal walking.	3 months
Gait Quality Index	The stance-swing phase ratio	3 months
First Double support phase	Refers to the portion of the gait cycle during walking when both feet are in contact with the ground simultaneously. It occurs at the beginning of the stance phase for one leg, immediately after heel strike, and ends when the opposite foot lifts off (toe-off). This phase contributes to stability during gait. Measured as a percentage of the total gait cycle.	3 months
Single Support Phase	Refers to the portion of the gait cycle during which only one foot is in contact with the ground bearing the entire body weight while the other foot is in the swing phase. It is essential for maintaining balance and forward progression during walking. Measured as a percentage of the total gait cycle.	3 months
Propulsion Index	This measures the subject's ability to propel the centre of mass forward during the single support stance phase.	3 months
Pelvic tilt range	Refers to the total angular movement of the pelvis in the sagittal plane during a specific activity, such as walking. It represents the difference between the maximum anterior tilt (forward rotation) and maximum posterior tilt (backward rotation) of the pelvis within a given cycle. Measured in degrees (°) to quantify the extent of pelvic rotation.	3 months
Pelvic obliquity range	Refers to the total angular movement of the pelvis in the coronal (frontal) plane during activities such as walking. It describes the difference between the maximum upward tilt (hip hike) and maximum downward tilt (hip drop) of one side of the pelvis relative to the opposite side. Measured in degrees (°) to quantify the range of motion.	3 months
Pelvic rotation range	Refers to the total angular movement of the pelvis in the transverse (horizontal) plane during activities such as walking. It represents the difference between the maximum forward rotation and maximum backward rotation of the pelvis around a vertical axis within a given cycle. Measured in degrees (°) to quantify the range of rotational motion.	3 months
Pelvic symmetry tilt index	Is a quantitative measure that evaluates the symmetry of pelvic tilt during movement. It assesses the degree of deviation in pelvic tilt between the left and right sides in the sagittal plane, providing insight into potential imbalances or asymmetries. Expressed as a percentage (%) to indicate the level of symmetry.	3 months
Pelvic symmetry obliquity index	Is a quantitative measure used to evaluate the symmetry of pelvic obliquity during movement. It quantifies the degree of deviation in upward or downward tilt of the pelvis on one side compared to the other in the coronal (frontal) plane, helping to identify potential imbalances or asymmetries. Expressed as a percentage (%) to represent the level of symmetry.	3 months
Pelvic symmetry rotation index	Is a quantitative measure used to assess the symmetry of pelvic rotation during movement, particularly in the transverse (horizontal) plane. It calculates the difference in rotational movement between the left and right sides of the pelvis, helping to identify any imbalances or asymmetries in pelvic motion during activities like walking.Expressed as a percentage (%) to indicate the level of symmetry.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone remmant (%)	Bone remment respect a healthy femur in percentage (%)	3 months
Long discrepancy (mm)	Long discrepancy in milimeters (mm) between healthy and tumoral leg. Positive discrepancy (tumoral leg longer) or negative discrepancy (tumoral leg shorter).	3 months

Collaborators and Investigators

• Sponsor: Cardenal Herrera University
• Investigators: Study Director: JUAN FRANCISCO LISÓN, PhD, Cardenal Herrera University

Publications and helpful links

General Publications

• Wilson PJ, Steadman P, Beckman EM, Connick MJ, Carty CP, Tweedy SM. Fitness, Function, and Exercise Training Responses after Limb Salvage With a Lower Limb Megaprosthesis: A Systematic Review. PM R. 2019 May;11(5):533-547. doi: 10.1002/pmrj.12045. Epub 2019 Mar 7.
• Morri M, Forni C, Ruisi R, Giamboi T, Giacomella F, Donati DM, Benedetti MG. Postoperative function recovery in patients with endoprosthetic knee replacement for bone tumour: an observational study. BMC Musculoskelet Disord. 2018 Oct 2;19(1):353. doi: 10.1186/s12891-018-2280-7.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2018
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Gait Analysis; Case-control study; Inertial Measurement Unit; Distal femur; Megaprosthesis; Orthopedic oncology; Musculoskeletal tumour
• Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA-62

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
• product manufactured in and exported from the U.S.: No