Hip OsteoarthritiskinesiofobNCT02786121
The Role of Kinesiophobia in the Functional Recovery After Hip Replacement
An observational study of Hip Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Several authors explain as the kinesiophobia plays an important role for the recovery after orthopaedic surgery. The aim of the investigators study is to investigate if the kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early recovery will be measured by the ILOA Score. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hip Osteoarthritis
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to May 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Total hip arthroplasties patients following chronic joint disease
Who may be able to join
- Primary hip joint replacement
- Clinical symptoms from more than 3 months
Who cannot join
- other orthopaedic surgery on the lower limb In the last year
- Not italian speaking
- Hip arthroplasty following fractures, revision surgery, and partial replacement
- Patients with concomitant neurologic (Parkinson, ictus), rheumatologic (rheumatoid arthritis) diseases,
- cognitive impaired.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Kinesiophobia a Predictive Factor of the Early Functional Recovery After Total Hip Replacement? - An Observational Study
Several authors explain as the kinesiophobia plays an important role for the recovery after orthopaedic surgery. The aim of the investigators study is to investigate if the kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will measure the fear level of movement. All the other variable that could influence the ILOA Score are identified and collected: age, sex, body max index, ability of patient pre-surgery, type of anesthesia, length of stay, pain, haemoglobin, possible complications.
- Conditions
- Hip Osteoarthritis
- Keywords
- hip replacement,, rehabilitation,, early ambulation,
- Medical subject headings
- Osteoarthritis, Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
Iowa Level of Assistance (ILOA) Score
The outcome considered was the level of autonomy achieved by the patients at the 5th days after surgery, measured by the Iowa Level of Assistance (ILOA) scale that took into account the patient's autonomy in carrying out functional 5 activities: supine-to-sitting, sitting-to-standing, walking, climbing 3 steps, and gait speed. The total score ranged from 0 to 50, where 0 was the patient's complete autonomy and 50 the maximum dependence. The score was based on the level of help that was supplied to the patient by the operator for the safe execution of activities, with a range between 0 and 30, and the type of assistive device used with a range between 0 and 20. The physiotherapist will collect the ILOA Score.
Measured: 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2017
- Study completionMay 2017
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 Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mattia Morri, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786121
- Sponsor's protocol ID
- 0008317
- Acronym
- kinesiofob
- Status last verified
- Aug 2017
- First submitted
- 15 Apr 2016
- Last updated
- 7 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Morri M, Venturini E, Franchini N, Ruisi R, Culcasi A, Ruggiero A, Govoni C, Benedetti MG. Is kinesiophobia a predictor of early functional performance after total hip replacement? A prospective prognostic cohort study. BMC Musculoskelet Disord. 2020 Nov 7;21(1):724. doi: 10.1186/s12891-020-03748-7.
PubMed 33160343
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Kinesiophobia a Predictive Factor of the Early Functional Recovery After Total Hip Replacement? - An Observational Study
- ClinicalTrials.gov ID
- NCT02786121
- Acronym / sponsor ID
- kinesiofob / 0008317
- Conditions
- Hip Osteoarthritis
- Keywords
- hip replacement,, rehabilitation,, early ambulation,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 30 May 2016 (estimated)
- 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.
Several authors explain as the kinesiophobia plays an important role for the recovery after orthopaedic surgery. The aim of the investigators study is to investigate if the kinesiophobia is able to influence the early recovery after total hip arthroplasty. The early recovery will be measured by the ILOA Score. The Tampa Scale of Kinesiophobia will measure the fear level of movement. All the other variable that could influence the ILOA Score are identified and collected: age, sex, body max index, ability of patient pre-surgery, type of anesthesia, length of stay, pain, haemoglobin, possible complications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Total hip arthroplasties patients following chronic joint disease
Key inclusion criteria (2 listed)
- Primary hip joint replacement
- Clinical symptoms from more than 3 months
Key exclusion criteria (5 listed)
- other orthopaedic surgery on the lower limb In the last year
- Not italian speaking
- Hip arthroplasty following fractures, revision surgery, and partial replacement
- Patients with concomitant neurologic (Parkinson, ictus), rheumatologic (rheumatoid arthritis) diseases,
- cognitive impaired.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Iowa Level of Assistance (ILOA) Score
Time frame: 5 days after surgery
The outcome considered was the level of autonomy achieved by the patients at the 5th days after surgery, measured by the Iowa Level of Assistance (ILOA) scale that took into account the patient's autonomy in carrying out functional 5 activities: supine-to-sitting, sitting-to-standing, walking, climbing 3 steps, and gait speed. The total score ranged from 0 to 50, where 0 was the patient's complete autonomy and 50 the maximum dependence. The score was based on the level of help that was supplied to the patient by the operator for the safe execution of activities, with a range between 0 and 30, and the type of assistive device used with a range between 0 and 20. The physiotherapist will collect the ILOA Score.
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 7 Aug 2017.
- Derived from this study: PubMed 33160343Morri M, Venturini E, Franchini N, Ruisi R, Culcasi A, Ruggiero A, Govoni C, Benedetti MG. Is kinesiophobia a predictor of early functional performance after total hip replacement? A prospective prognostic cohort study. BMC Musculoskelet Disord. 2020 Nov 7;21(1):724. doi: 10.1186/s12891-020-03748-7.
- Individual participant dataSharing planned: No
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Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
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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.
Mattia Morri principal investigator
Istituto Ortopedico Rizzoli
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 Hip Osteoarthritis, run by Istituto Ortopedico Rizzoli 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 5 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 7 Aug 2017. 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?
Iowa Level of Assistance (ILOA) Score (time frame: 5 days after surgery). 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 NCT02786121, 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 7 Aug 2017.