The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty (Fast-Track2)

August 29, 2023 updated by: Fondazione Don Carlo Gnocchi Onlus

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20148
        • IRCCS Fondazione Don Carlo Gnocchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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
Subjects that received hip arthroplasty 2-3 days before admission to undergo a rehabilitation period in our rehabilitation hospital.
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)
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)
From Admission (T0) up to 15/21 days (discharge) (T1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Modified Barthel Index
Time Frame: From Admission (T0) up to 15/21 days (discharge) (T1)
Change from Admission of Modified Bathel Index untill 15/21 days (Discharge)
From Admission (T0) up to 15/21 days (discharge) (T1)
Change in International Knee Society score
Time Frame: From Admission (T0) up to 15/21 days (discharge) (T1)
Change from Admission of International Knee Society score untill 15/21 days (Discharge)
From Admission (T0) up to 15/21 days (discharge) (T1)
Change in Merlè D'Aubigne score
Time Frame: From Admission (T0) up to 15/21 days (discharge) (T1)
Change from Admission of Merlè D'Aubigne score untill 15/21 days (Discharge)
From Admission (T0) up to 15/21 days (discharge) (T1)
Change in Numerical Pain Rating Scale
Time Frame: From Admission (T0) up to 15/21 days (discharge) (T1)
Change from Admission of Numerical Pain Rating Scale untill 15/21 days (Discharge)
From Admission (T0) up to 15/21 days (discharge) (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione Don Carlo Gnocchi Onlus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JP-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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