The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty (Fast-Track2)

The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty: a Pilot Observational Study Based on Kinematic and Kinetic Parameters

This study aims to evaluate the effectiveness of rehabilitation on gait recovery in subjects after knee or hip arthroplasty. Assessment is performed the day after admission (T0) and the day of discharge (T1), in a post-acute rehabilitation hospital, through an optoelectronic system (BTS DX-400). Other functional scales are administered to the subjects. during the rehabilitation period, subjects received conventional physiotherapy.

Study Overview

• Status: Completed
• Conditions: Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Hip
• Intervention / Treatment: Other: Conventional physiotherapy

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20148
    • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

In this study, we included subjects who underwent in the previous 3/4 days for knee or hip arthroplasty subjects, before admission to our post-acute rehabilitation hospital, where they receive conventional physiotherapy.

Description

Knee and Hip Arthroplasty subjects

Inclusion Criteria:

• Subjects > 18 years;
• Both Sexs;
• Knee or Hip Arthroplasty in the previous 3-4 days before admission;
• Subjects with clinical stability at admission (Hemoglobin > 9 g/l).

Exclusion Criteria:

• Fever at admission;
• Any rheumatic or systemic diseases;
• Previous surgery at the lower limbs (6 months before admission) or other arthroplasties at the lower limbs;
• MiniMental State Examination < 24;
• Other neurologic disorders.

For the healthy volunteers

Inclusion Criteria:

• Subjects age-matched with the subjects in the hip and knee group.

Exclusion Criteria:

• Any disorder that could negatively affect gait perfomance.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Knee Arthroplasty Group; Subjects that received knee arthroplasty 2-3 days before admission to undergo a rehabilitation period in our rehabilitation hospital.	Other: Conventional physiotherapy; The subjects will receive rehabilitation according to the guidelines on the management of subjects after knee or hip arthroplasty, recovery of joint Range of Motion, recovery of lower limb strength, education to the crutches management, and stairs climbing and descending
Hip Arthroplasty Group; Subjects that received hip arthroplasty 2-3 days before admission to undergo a rehabilitation period in our rehabilitation hospital.	Other: Conventional physiotherapy; The subjects will receive rehabilitation according to the guidelines on the management of subjects after knee or hip arthroplasty, recovery of joint Range of Motion, recovery of lower limb strength, education to the crutches management, and stairs climbing and descending
Age-Matched healthy Group; Subjects age-matched with those included in the knee and hip group. Subjects are asked to walk at their self-selected speed and at low speed matchable with those of the knee and hip group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Profile Score	Change from Admission of Gait Profile Score untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in Gai Deviation Index	Change from Admission of Gait Deviation Index untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in Gait Variable Scores	Change from Admission of Gait Variable Score untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in gait speed	Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in gait cycle length	Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in step length	Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in gait cadence	Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in gait cycle duration	Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in stance phase duration	Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in swing phase duration	Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in single support phase duration	Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in double support phase duration	Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Modified Barthel Index	Change from Admission of Modified Bathel Index untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in International Knee Society score	Change from Admission of International Knee Society score untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in Merlè D'Aubigne score	Change from Admission of Merlè D'Aubigne score untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)
Change in Numerical Pain Rating Scale	Change from Admission of Numerical Pain Rating Scale untill 15/21 days (Discharge)	From Admission (T0) up to 15/21 days (discharge) (T1)

Collaborators and Investigators

• Sponsor: Fondazione Don Carlo Gnocchi Onlus

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Physical Therapy Modalities; Gait Analysis
• Other Study ID Numbers: JP-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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