- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03230942
Effect of Pre-op Patient Education on Functional Outcomes After TKA
Effect of Pre-operative Patient Education Program on Functional Outcomes After Total Knee Arthroplasty
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study will be developed in the dependencies of the Laboratory of Biomechanics of the Center for Health Sciences and Sports of UDESC. In the preoperative period the subjects will be informed about their physical conditions as well as signs and symptoms of the postoperative period. One group (GI) will receive this information verbally and one leaflet while the other group (GC) will receive only verbal information. The allocation in these groups will be through a lottery, carried out by a member of the team who will not participate in the evaluation stages.
This staff member will read the booklet individually for each GI participant, in a reserved room, before handing out the leaflet to take home. GI participants will be encouraged to reread the information in the home environment and will be asked about the completion of this in the following steps by the staff member responsible for the blinding.
All participants included in the study will perform the kinematic, kinetic and electromyographic gait analysis as well as evaluation of fear of movement, functional mobility and self-perceived functionality in the pre (baseline)-and postoperative period (6 weeks and after 6 months).
The total duration of each evaluation will be approximately 2 (two) hours and 30 (thirty) minutes and all collections will be carried out by the same team. The participant will be allowed to stop the test if they feel pain or become fatigued.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Santa Catarina
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Florianópolis, Santa Catarina, Brazil, 88080350
- Center for Health and Sport Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Literate;
- Elective submission of unilateral total knee arthroplasty (TKA) due to osteoarthrosis
- Individuals without other arthroplasties in the lower limb in the last 6 months;
- Range of motion greater than 90 degrees or operated contralateral knee.
Exclusion Criteria:
- Associated condition that impedes performance in gait tests, including significant osteoarthrosis in the contralateral knee or hips (defined as pain greater than or equal to 5 on the analog visual pain scale);
- Absence or abandonment in the study follow-up sessions.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient education program
Pre-operative education and pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
|
Verbal and booklet about symptoms and physical conditions pos knee replacement
Other Names:
Physical therapy treatment
|
Active Comparator: Control - only pos-op rehabilitation
Pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
|
Physical therapy treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed up And Go Test score
Time Frame: pre-operative; 6 weeks; 6 months
|
The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.
The TUG has good inter-rater and intra-rater reliability and validity for functional testing in older adults at risk for falls.
The test is easy to administer and can be completed in two to three minutes.Change from baseline (pre-operative) in the functional mobility.
The variable will be measured in seconds.
|
pre-operative; 6 weeks; 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EMG activity
Time Frame: pre-operative; 6 weeks; 6 months
|
Electromyographic activity of rectus femoris, vastus lateralis, vastus medialis, vastus medial and gastrocnemius by NORAXON WIRELESS EMG.
Change from baseline (pre-operative).The variable will be measured in % of maximal voluntary contraction.
|
pre-operative; 6 weeks; 6 months
|
Kinematics
Time Frame: pre-operative; 6 weeks; 6 months
|
Gait analysis by VICON three-dimensional ,10-camera motion capture system.The outcome measurement is assessed at pre-operation, six weeks and six month after operation.
Change from baseline (pre-operative).
The variable will be measured in degrees.
|
pre-operative; 6 weeks; 6 months
|
Kinetics
Time Frame: pre-operative; 6 weeks; 6 months
|
Gait analysis by AMTI plate force.
The outcome measurement is assessed at pre-operation, six weeks and six month after operation.
Change from baseline (pre-operative).
The variable will be measured in newtons
|
pre-operative; 6 weeks; 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
kinesiophobia
Time Frame: pre-operative; 6 weeks; 6 months
|
Fear of movement.
The variable will be measured in points (score).
|
pre-operative; 6 weeks; 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Gilmar M Santos, PhD, University of State of Santa Catarina
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UDESantaCatarina
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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