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Clinical Trials/NCT04803578
NCT04803578
Completed
Not Applicable

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

Fondazione Don Carlo Gnocchi Onlus1 site in 1 country90 target enrollmentJanuary 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arthroplasty, Replacement, Hip
Sponsor
Fondazione Don Carlo Gnocchi Onlus
Enrollment
90
Locations
1
Primary Endpoint
Change in Gait Variable Scores
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2017
End Date
November 30, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in Gait Variable Scores

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

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

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Change in step length

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

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

Change from Admission of Gait Deviation Index untill 15/21 days (Discharge)

Change in gait cadence

Time Frame: 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

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

Change from Admission of Spatio-Temporal parameters untill 15/21 days (Discharge)

Secondary Outcomes

  • Change in Modified Barthel Index(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 International Knee Society 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 Sites (1)

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