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

NCT03849638 | Unknown

• 1 other identifier: 54/18 PAR ComEt CBM
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip

Keywords

gait analysis; gait training; biofeedback

Outcome Measures

Primary Outcomes (7)

• 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

Interventions

Gait training with real time biofeedback OTHER

Patients presenting asymmetry of the kinematic parameters of the step to the evaluation with sensorized treadmill, will undergo gait training program. The training program consists of 20 session (1 session/day) of gait training. Daily gait training will last 30 minutes as distributed: * 5 minutes of heating at a comfortable speed for the patient * Three 5-minute sessions of gait training with biofeedback interspersed with a break of 5 minutes each.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Rehabilitation Department - Campus Bio-Medico University

Roma, RM, 00128, Italy

RECRUITING

Central Study Contacts

Federica Bressi, MD

CONTACT

+390622541624; f.bressi@unicampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 21, 2019
• Study Start: December 6, 2018
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

IT (1)