- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02786121
The Role of Kinesiophobia in the Functional Recovery After Hip Replacement (kinesiofob)
August 4, 2017 updated by: Istituto Ortopedico Rizzoli
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
200
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
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Bologna, Italy, 40136
- Istituto Ortopedico Rizzoli
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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
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Total hip arthroplasties patients following chronic joint disease
Description
Inclusion Criteria:
- Primary hip joint replacement
- Clinical symptoms from more than 3 months
Exclusion Criteria:
- 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.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Iowa Level of Assistance (ILOA) Score
Time Frame: 5 days after surgery
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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.
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5 days after surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mattia Morri, Istituto Ortopedico Rizzoli
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2016
Primary Completion (Actual)
April 1, 2017
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
April 15, 2016
First Submitted That Met QC Criteria
May 25, 2016
First Posted (Estimate)
May 30, 2016
Study Record Updates
Last Update Posted (Actual)
August 7, 2017
Last Update Submitted That Met QC Criteria
August 4, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0008317
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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