Arthroplasty, Replacement, KneeWVPTNCT03849638
Gait Analysis and Gait Training in Patient With Total Hip or Total Knee Replacement
A study testing Gait training with real time biofeedback in people with Arthroplasty, Replacement, Knee and Arthroplasty, Replacement, Hip, run by Campus Bio-Medico University at 1 site in Italy.
Trial summary
The main objective of the present study is the evaluation of the kinematic parameters of gait and distribution of the load, recorded thruogh a sensorized treadmill, on lower limbs in patients at 1 year from Total Hip Replacement or Total Knee Replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Hip
- What is being tested?
- Gait training with real time biofeedback
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 6 Dec 2018to 31 Dec 2024
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mini Mental State Examination ≥ 24
- 12 months after total hip or total knee replacement
Who cannot join
- impossibility to perform a walking test
- disabling cardiovascular and osteo-arthro-muscular problems that can impair walking tests
- central or peripheral neurological disorders that compromise the sensory-motor skills of the patient under examination and / or the degree of collaboration
- patients who have not signed informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Rehabilitation Department - Campus Bio-Medico University
Roma, RM, 00128
Federica Bressi, MD, +39 06 22541 624, f.bressi@unicampus.it
Silvia Sterzi, Full Professor
About this study
Official title: Gait Analysis and Gait Training in Subjects 1 Year After Total Hip or Total Knee Replacement by Means
The main objective of the present study is the evaluation of the kinematic parameters of gait and distribution of the load, recorded thruogh a sensorized treadmill, on lower limbs in patients at 1 year from Total Hip Replacement or Total Knee Replacement.
The secondary objective is to evaluate the effects of gait training with biofeedback by means of a sensorized treadmill in patients with asymmetry of the kinematic parameters of the step and of distribution of the load on the lower limbs.
- Being tested
- Gait training with real time biofeedback
- Keywords
- gait analysis, gait training, biofeedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait training with real time biofeedbackOther
Patients presenting asymmetry of the kinematic parameters of the step to the evaluation with sensorized treadmill, will undergo gait training program.
The training program consists of 20 session (1 session/day) of gait training. Daily gait training will last 30 minutes as distributed:
- 5 minutes of heating at a comfortable speed for the patient
- Three 5-minute sessions of gait training with biofeedback interspersed with a break of 5 minutes each.
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Speed
meters/second
Measured: immediately after treatment
Step Length
length in meters
Measured: immediately after treatment
Ground Contact Time
Time in seconds
Measured: immediately after treatment
Hip Kinematics
angles (degrees) of hip ROM
Measured: immediately after treatment
Knee Kinematics
angles (degrees) of knee ROM
Measured: immediately after treatment
Ankle Kinematics
angles (degrees) of ankle ROM
Measured: immediately after treatment
Lower limb loading
load percentage distribution on lower limbs
Measured: immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start6 Dec 2018
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federica Bressi, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849638
- Sponsor's protocol ID
- 54/18 PAR ComEt CBM
- Acronym
- WVPT
- Status last verified
- Apr 2023
- First submitted
- 15 Feb 2019
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Analysis and Gait Training in Subjects 1 Year After Total Hip or Total Knee Replacement by Means
- ClinicalTrials.gov ID
- NCT03849638
- Acronym / sponsor ID
- WVPT / 54/18 PAR ComEt CBM
- Keywords
- gait analysis, gait training, biofeedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Feb 2019 (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.
The main objective of the present study is the evaluation of the kinematic parameters of gait and distribution of the load, recorded thruogh a sensorized treadmill, on lower limbs in patients at 1 year from Total Hip Replacement or Total Knee Replacement.
The secondary objective is to evaluate the effects of gait training with biofeedback by means of a sensorized treadmill in patients with asymmetry of the kinematic parameters of the step and of distribution of the load on the lower limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mini Mental State Examination ≥ 24
- 12 months after total hip or total knee replacement
Key exclusion criteria (4 listed)
- impossibility to perform a walking test
- disabling cardiovascular and osteo-arthro-muscular problems that can impair walking tests
- central or peripheral neurological disorders that compromise the sensory-motor skills of the patient under examination and / or the degree of collaboration
- patients who have not signed informed consent
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 |
|---|---|---|
| Gait training with real time biofeedbackPatients presenting asymmetry of the kinematic parameters of the step to the evaluation with sensorized treadmill, will undergo gait training program. The training program consists of 20 session (1 session/day) of gait training. Daily gait training will last 30 minutes as distributed: * 5 minutes of heating at a comfortable speed for the patient * Three 5-minute sessions of gait training with biofeedback interspersed with a break of 5 minutes each. | Other | – |
Primary outcome
Gait Speed
Time frame: immediately after treatment
meters/second
Step Length
Time frame: immediately after treatment
length in meters
Ground Contact Time
Time frame: immediately after treatment
Time in seconds
Hip Kinematics
Time frame: immediately after treatment
angles (degrees) of hip ROM
Knee Kinematics
Time frame: immediately after treatment
angles (degrees) of knee ROM
Ankle Kinematics
Time frame: immediately after treatment
angles (degrees) of ankle ROM
Lower limb loading
Time frame: immediately after treatment
load percentage distribution on lower limbs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
Related trials for Arthroplasty, Replacement, Knee
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty
Arthroplasty, Replacement, Knee, Pain, Postoperative
Not yet recruitingObservational study
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Arthroplasty, Arthroplasty Replacement, Knee
RecruitingObservational study
Tau Pathology in the Brain After Hip or Knee Replacement Surgery
Postoperative Cognitive Dysfunction, Alzheimer Disease
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training with real time biofeedback in people with Arthroplasty, Replacement, Knee and Arthroplasty, Replacement, Hip, run by Campus Bio-Medico University 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Apr 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federica Bressi, MD (+390622541624, f.bressi@unicampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Speed (time frame: immediately after treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.