Total Hip ArthroplastyNCT03624998
The Effects of Cognitive Functioning on Gait Rehabilitation
A study testing Cognitive and physiatric testing in people with Total Hip Arthroplasty, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The present study is designed to investigate whether the behavioral and cognitive functioning might predict the outcome of the rehabilitation of gait related abilities in orthopedic patients submitted to elective surgery (total hip arthroplasty). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- Cognitive and physiatric testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2018to 2 Apr 2020
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age comprised between 50 and 80 years
- Submission to total hip arthroplasty
- Admission to the local rehabilitation program
- Signature of the informed consent
Who cannot join
- Major medical issues (e.g. neurologial or neurodegenerative diseases)
- Assumption of psychiatric drugs
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Galeazzi
Milan, Italia, 20161
Laura Zapparoli, PhD, 02 6621 4444, laura.zapparoli@gmail.com
Laura Zapparoli, PhD
About this study
Official title: The Effects of Cognitive and Behavioral Functioning on Gait Rehabilitation in Orthopedic Patients Submitted to Total Hip Arthroplasty
The present study is designed to investigate whether the behavioral and cognitive functioning might predict the outcome of the rehabilitation of gait related abilities in orthopedic patients submitted to elective surgery (total hip arthroplasty). The evaluation of gait related abilities will be performed with specific physiatric tests, while cognitive functioning will be studied by means of an extended neuropsychological battery.
- Conditions
- Total Hip Arthroplasty
- Being tested
- Cognitive and physiatric testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and physiatric testingOther
Neuropsychological test battery and physiatric tests
| Study group | Role | What they receive |
|---|---|---|
| THA Patients | Experimental | Orthopedic patients submitted to elective surgery (THA - Total Hip Arthroplasty) Receives: Other: Cognitive and physiatric testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between the cognitive functioning and gait rehabilitation
We will measure the patients' cognitive functioning, investigated by means of a extensive neuropsychological and behavioral battery and the outcome of gait rehabilitation, measured at the enrollment, at 7 days after the enrollment and at 15 days after the enrollment.
Measured: The first measures will be taken at the enrollment, at 7 days after the enrollment and at 15 days after the enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start3 Apr 2018
- Primary completion2 Apr 2020 (estimated)
- Study completion2 Apr 2020 (estimated)
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 Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624998
- Sponsor's protocol ID
- L3031
- Status last verified
- Aug 2018
- First submitted
- 23 May 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Negrini F, Preti M, Zirone E, Mazziotti D, Biffi M, Pelosi C, Banfi G, Zapparoli L. The Importance of Cognitive Executive Functions in Gait Recovery After Total Hip Arthroplasty. Arch Phys Med Rehabil. 2020 Apr;101(4):579-586. doi: 10.1016/j.apmr.2019.12.004. Epub 2020 Jan 7.
PubMed 31917194
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cognitive and Behavioral Functioning on Gait Rehabilitation in Orthopedic Patients Submitted to Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03624998
- Acronym / sponsor ID
- L3031
- Conditions
- Total Hip Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 2 Apr 2020 (estimated)
- Study completion
- 2 Apr 2020 (estimated)
- First posted
- 10 Aug 2018 (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 present study is designed to investigate whether the behavioral and cognitive functioning might predict the outcome of the rehabilitation of gait related abilities in orthopedic patients submitted to elective surgery (total hip arthroplasty). The evaluation of gait related abilities will be performed with specific physiatric tests, while cognitive functioning will be studied by means of an extended neuropsychological battery.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| THA Patients | Experimental | Other: Cognitive and physiatric testingOrthopedic patients submitted to elective surgery (THA - Total Hip Arthroplasty) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age comprised between 50 and 80 years
- Submission to total hip arthroplasty
- Admission to the local rehabilitation program
- Signature of the informed consent
Key exclusion criteria (3 listed)
- Major medical issues (e.g. neurologial or neurodegenerative diseases)
- Assumption of psychiatric drugs
- Pregnancy
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 |
|---|---|---|
| Cognitive and physiatric testingNeuropsychological test battery and physiatric tests | Other | THA Patients |
Primary outcome
Relationship between the cognitive functioning and gait rehabilitation
Time frame: The first measures will be taken at the enrollment, at 7 days after the enrollment and at 15 days after the enrollment.
We will measure the patients' cognitive functioning, investigated by means of a extensive neuropsychological and behavioral battery and the outcome of gait rehabilitation, measured at the enrollment, at 7 days after the enrollment and at 15 days after the enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 31917194Negrini F, Preti M, Zirone E, Mazziotti D, Biffi M, Pelosi C, Banfi G, Zapparoli L. The Importance of Cognitive Executive Functions in Gait Recovery After Total Hip Arthroplasty. Arch Phys Med Rehabil. 2020 Apr;101(4):579-586. doi: 10.1016/j.apmr.2019.12.004. Epub 2020 Jan 7.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive and physiatric testing in people with Total Hip Arthroplasty, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio 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 4 inclusion and 3 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 14 Aug 2018. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between the cognitive functioning and gait rehabilitation (time frame: The first measures will be taken at the enrollment, at 7 days after the enrollment and at 15 days after the enrollment.). 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 NCT03624998, 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 14 Aug 2018.