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Completed

NCT Number: NCT03230942

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

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.

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Key information

Conditions

Knee Arthropathy Arthritis Joint Diseases Musculoskeletal Diseases

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Health and Sport Sciences

Florianópolis, Santa Catarina, 88080350, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre-operative education

Other

Verbal and booklet about symptoms and physical conditions pos knee replacement

Other names: Patient education program

Pos-operative rehabilitation

Other

Physical therapy treatment

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Other outcomes

  1. kinesiophobia

    Time frame: pre-operative; 6 weeks; 6 months

    Fear of movement. The variable will be measured in points (score).

Sponsors and collaborators

Lead sponsor

University of the State of Santa Catarina

Other

Registry information

Official study title

Effect of Pre-operative Patient Education Program on Functional Outcomes After Total Knee Arthroplasty

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 27, 2017
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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