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Effect of Pre-op Patient Education on Functional Outcomes After TKA

Primary Purpose

Knee Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pre-operative education
Pos-operative rehabilitation
Sponsored by
University of the State of Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Arthropathy focused on measuring patient education, arthritis, knee, arthroplasty, gait

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Center for Health and Sport Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient education program

Control - only pos-op rehabilitation

Arm Description

Pre-operative education and pos-operative rehabilitation in individuals will be undergo knee arthroplasty.

Pos-operative rehabilitation in individuals will be undergo knee arthroplasty.

Outcomes

Primary Outcome Measures

Timed up And Go Test score
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.

Secondary Outcome Measures

EMG activity
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.
Kinematics
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.
Kinetics
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

Full Information

First Posted
July 24, 2017
Last Updated
April 16, 2019
Sponsor
University of the State of Santa Catarina
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1. Study Identification

Unique Protocol Identification Number
NCT03230942
Brief Title
Effect of Pre-op Patient Education on Functional Outcomes After TKA
Official Title
Effect of Pre-operative Patient Education Program on Functional Outcomes After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the State of Santa Catarina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study aims to evaluate the effect of preoperative patient education program on functional mobility, gait, postural control, and kinesiophobia level in subjects with TKA. Patients of both gender will be recruited unilaterally in the city of Florianopolis and referred by an orthopedist to the Physiotherapy Clinic of UDESC. They are divided into two groups: one that will receive verbal guidance and a booklet with related information such as your physical condition as well as signs and symptoms in the postoperative period and a group that will receive only verbal guidance.Both groups will be evaluated by a blind evaluator in the preoperative and postoperative periods (6 weeks and 6 months). The evaluations will be divided into five stages. Anthropometric measurements of the individual will be made and then the WOMAC functionality questionnaire and the Kinesiophobia Cover Scale will be applied.Then the individual will walk for 5 meters for three-dimensional gait analysis and electromyographic analysis of the quadriceps and femoral biceps. The evaluation of functional mobility by Timed Up And Go and assessment of postural control in an equilibrium platform will also be performed. Statistical data will be analyzed by analysis of variance 3x2 considering factor time (pre, post 6 weeks and post 6 months) and groups (with and without information leaflet). The value of p will be 0.05.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthropathy
Keywords
patient education, arthritis, knee, arthroplasty, gait

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
All patients will be assessed for functional outcomes by a rater blinded to the study arm
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient education program
Arm Type
Experimental
Arm Description
Pre-operative education and pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
Arm Title
Control - only pos-op rehabilitation
Arm Type
Active Comparator
Arm Description
Pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
Intervention Type
Other
Intervention Name(s)
Pre-operative education
Other Intervention Name(s)
Patient education program
Intervention Description
Verbal and booklet about symptoms and physical conditions pos knee replacement
Intervention Type
Other
Intervention Name(s)
Pos-operative rehabilitation
Intervention Description
Physical therapy treatment
Primary Outcome Measure Information:
Title
Timed up And Go Test score
Description
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.
Time Frame
pre-operative; 6 weeks; 6 months
Secondary Outcome Measure Information:
Title
EMG activity
Description
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.
Time Frame
pre-operative; 6 weeks; 6 months
Title
Kinematics
Description
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.
Time Frame
pre-operative; 6 weeks; 6 months
Title
Kinetics
Description
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
Time Frame
pre-operative; 6 weeks; 6 months
Other Pre-specified Outcome Measures:
Title
kinesiophobia
Description
Fear of movement. The variable will be measured in points (score).
Time Frame
pre-operative; 6 weeks; 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilmar M Santos, PhD
Organizational Affiliation
University of State of Santa Catarina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health and Sport Sciences
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88080350
Country
Brazil

12. IPD Sharing Statement

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Effect of Pre-op Patient Education on Functional Outcomes After TKA

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