Analysis of Spatiotemporal Gait Parameters in Patients With Megaprosthesis.

NCT05202873 | Completed

• 1 other identifier: UNIVERSITY CARDENAL HERRERA-62
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Distal Femoral Musculoskeletal Tumors; Megaprosthesis

Keywords

Gait Analysis; Case-control study; Megaprosthesis; Orthopedic oncology; Musculoskeletal tumour; Distal femur; Inertial Measurement Unit

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (2)

• Bone remmant (%)

  3 months

• Long discrepancy (mm)

  3 months

Study Arms (2)

Cases

Patients with distal femoral megaprosthesis due to musculoskeletal tumor

Diagnostic Test: Gait analysis

Control

Healthy subjects

Diagnostic Test: Gait analysis

Interventions

Gait analysis DIAGNOSTIC_TEST

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; Control

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardenal Herrera University: lead

Study Sites (1)

Universidad Ceu Cardenal Herrera

Valencia, 46006, Spain

Location

Related Publications (2)

• 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.

  PMID: 30844129 BACKGROUND

• 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.

  PMID: 30285683 BACKGROUND

MeSH Terms

Interventions

Gait Analysis

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• JUAN FRANCISCO LISÓN, PhD

  Cardenal Herrera University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Deparment of Biomedical Sciences

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 24, 2022
• Study Start: February 8, 2018
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)