Arthroplasty, Replacement, HipFast-Track2NCT04803578
The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty
An observational study of Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- Conventional physiotherapy
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2017to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
- Subjects age-matched with the subjects in the hip and knee group.
Who cannot join
- 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
- Any disorder that could negatively affect gait perfomance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Conventional physiotherapy
- Keywords
- Physical Therapy Modalities, Gait Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physiotherapyOther
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
| Study group | Role | What they receive |
|---|---|---|
| Knee Arthroplasty Group | Subjects that received knee arthroplasty 2-3 days before admission to undergo a rehabilitation period in our rehabilitation hospital. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gait Profile Score
Change from Admission of Gait Profile Score untill 15/21 days (Discharge)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: From Admission (T0) up to 15/21 days (discharge) (T1)
Secondary outcomes (4)
Change in Modified Barthel Index
Change from Admission of Modified Bathel Index untill 15/21 days (Discharge)
Measured: From Admission (T0) up to 15/21 days (discharge) (T1)
Change in International Knee Society score
Change from Admission of International Knee Society score untill 15/21 days (Discharge)
Measured: From Admission (T0) up to 15/21 days (discharge) (T1)
Change in Merlè D'Aubigne score
Change from Admission of Merlè D'Aubigne score untill 15/21 days (Discharge)
Measured: From Admission (T0) up to 15/21 days (discharge) (T1)
Change in Numerical Pain Rating Scale
Change from Admission of Numerical Pain Rating Scale untill 15/21 days (Discharge)
Measured: From Admission (T0) up to 15/21 days (discharge) (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Jan 2017
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
- More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803578
- Sponsor's protocol ID
- JP-003
- Acronym
- Fast-Track2
- Status last verified
- Aug 2023
- First submitted
- 4 Mar 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40179654
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Rehabilitation in Gait Recovery After Knee or Hip Arthroplasty: a Pilot Observational Study Based on Kinematic and Kinetic Parameters
- ClinicalTrials.gov ID
- NCT04803578
- Acronym / sponsor ID
- Fast-Track2 / JP-003
- Keywords
- Physical Therapy Modalities, Gait Analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Knee Arthroplasty Group | – | Other: Conventional physiotherapySubjects that received knee arthroplasty 2-3 days before admission to undergo a rehabilitation period in our rehabilitation hospital. |
| Hip Arthroplasty Group | – | Other: Conventional physiotherapySubjects that received hip arthroplasty 2-3 days before admission to undergo a rehabilitation period in our rehabilitation hospital. |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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).
- Subjects age-matched with the subjects in the hip and knee group.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional physiotherapyThe 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 | Other | Hip Arthroplasty Group, Knee Arthroplasty Group |
Primary outcome
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 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 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 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 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 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 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 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 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 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)
4 secondary outcomes
Change in Modified Barthel Index
Time frame: 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 in Merlè D'Aubigne score
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Derived from this study: PubMed 40179654Pollet 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gait Profile Score (time frame: From Admission (T0) up to 15/21 days (discharge) (T1)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04803578, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.