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

Completed

• Conditions: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee
• Interventions: Other: Conventional physiotherapy

• Registration Number: NCT04803578
• Lead Sponsor: Fondazione Don Carlo Gnocchi Onlus

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-17
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Knee Arthroplasty Group	Conventional physiotherapy	Subjects that received knee arthroplasty 2-3 days before admission to undergo a rehabilitation period in our rehabilitation hospital.
Hip Arthroplasty Group	Conventional physiotherapy	Subjects that received hip arthroplasty 2-3 days before admission to undergo a rehabilitation period in our rehabilitation hospital.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

IRCCS Fondazione Don Carlo Gnocchi; 🇮🇹 Milan, Italy