Clinical trial NCT03230942: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthropathy
Keywords: patient education
arthritis
knee
arthroplasty
gait
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Timed up And Go Test score
timeFrame: pre-operative; 6 weeks; 6 months
Secondary outcomes:
measure: EMG activity
timeFrame: pre-operative; 6 weeks; 6 months
measure: Kinematics
timeFrame: pre-operative; 6 weeks; 6 months
measure: Kinetics
timeFrame: pre-operative; 6 weeks; 6 months
Other outcomes:
measure: kinesiophobia
timeFrame: pre-operative; 6 weeks; 6 months
Locations:
city: Florianópolis
country: Brazil
facility: Center for Health and Sport Sciences
state: Santa Catarina
Study officials:
affiliation: University of State of Santa Catarina
name: Gilmar M Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References: