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

NCT04803578 | Completed

• 1 other identifier: JP-003
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Keywords

Physical Therapy Modalities; Gait Analysis

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (4)

• Change in Modified Barthel Index

  From Admission (T0) up to 15/21 days (discharge) (T1)

• Change in International Knee Society score

  From Admission (T0) up to 15/21 days (discharge) (T1)

• Change in Merlè D'Aubigne score

  From Admission (T0) up to 15/21 days (discharge) (T1)

• Change in Numerical Pain Rating Scale

  From Admission (T0) up to 15/21 days (discharge) (T1)

Study Arms (3)

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

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

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

Interventions

Conventional physiotherapy OTHER

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; Knee Arthroplasty Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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
• Subjects age-matched with the subjects in the hip and knee group.
• Any disorder that could negatively affect gait perfomance.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

Location

Related Publications (1)

• Pollet J, Pullara R, Bianchi LNC, Falso MV, Gobbo M, Buraschi R. Gait improvements in the early post-surgery rehabilitation phase in subjects receiving a total knee or hip arthroplasty: A prospective study. Gait Posture. 2025 Jul;120:25-33. doi: 10.1016/j.gaitpost.2025.03.024. Epub 2025 Mar 27.

  PMID: 40179654 DERIVED

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 17, 2021
• Study Start: January 1, 2017
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

IT (1)