The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty

Arthroplasty, Replacement, Knee Clinical Trial

— Fast-Track2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04803578
• Other study ID #: JP-003
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: November 30, 2022

Study information

• Verified date: August 2023
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)