Gait Analysis and Gait Training in Patient With Total Hip or Total Knee Replacement (WVPT)

Gait Analysis and Gait Training in Subjects 1 Year After Total Hip or Total Knee Replacement by Means

The main objective of the present study is the evaluation of the kinematic parameters of gait and distribution of the load, recorded thruogh a sensorized treadmill, on lower limbs in patients at 1 year from Total Hip Replacement or Total Knee Replacement.

The secondary objective is to evaluate the effects of gait training with biofeedback by means of a sensorized treadmill in patients with asymmetry of the kinematic parameters of the step and of distribution of the load on the lower limbs.

Study Overview

• Status: Recruiting
• Conditions: Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
• Intervention / Treatment: Other: Gait training with real time biofeedback

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Federica Bressi, MD; Phone Number: +390622541624; Email: f.bressi@unicampus.it

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00128
      • Recruiting
      • Rehabilitation Department - Campus Bio-Medico University
      • Contact: Federica Bressi, MD; Phone Number: +39 06 22541 624; Email: f.bressi@unicampus.it
      • Principal Investigator: Silvia Sterzi, Full Professor
      • Principal Investigator: Federica Bressi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Mini Mental State Examination ≥ 24
• 12 months after total hip or total knee replacement

Exclusion Criteria:

• impossibility to perform a walking test
• disabling cardiovascular and osteo-arthro-muscular problems that can impair walking tests
• central or peripheral neurological disorders that compromise the sensory-motor skills of the patient under examination and / or the degree of collaboration
• patients who have not signed informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Speed	meters/second	immediately after treatment
Step Length	length in meters	immediately after treatment
Ground Contact Time	Time in seconds	immediately after treatment
Hip Kinematics	angles (degrees) of hip ROM	immediately after treatment
Knee Kinematics	angles (degrees) of knee ROM	immediately after treatment
Ankle Kinematics	angles (degrees) of ankle ROM	immediately after treatment
Lower limb loading	load percentage distribution on lower limbs	immediately after treatment

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2018
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: February 20, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: biofeedback; gait analysis; gait training
• Other Study ID Numbers: 54/18 PAR ComEt CBM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No