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

Arthroplasty, Replacement, Knee Clinical Trial

— WVPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03849638
• Other study ID #: 54/18 PAR ComEt CBM
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Campus Bio-Medico University
• Contact: Federica Bressi, MD
• Phone: +390622541624
• Email: f.bressi[@]unicampus.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Hip
• Arthroplasty, Replacement, Knee

Intervention

Other:
• Gait training with real time biofeedback
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.

Locations

Country	Name	City	State
Italy	Rehabilitation Department - Campus Bio-Medico University	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

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