Clinical trial NCT04803578: The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty
Official title: The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty: a Pilot Observational Study Based on Kinematic and Kinetic Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Keywords: Physical Therapy Modalities
Gait Analysis
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Gait Profile Score
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in Gai Deviation Index
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in Gait Variable Scores
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in gait speed
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in gait cycle length
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in step length
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in gait cadence
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in gait cycle duration
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in stance phase duration
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in swing phase duration
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in single support phase duration
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in double support phase duration
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
Secondary outcomes:
measure: Change in Modified Barthel Index
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in International Knee Society score
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in Merlè D'Aubigne score
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
measure: Change in Numerical Pain Rating Scale
timeFrame: From Admission (T0) up to 15/21 days (discharge) (T1)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
Study officials:
References: