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CompletedNCT03230942Updated Apr 18, 2019

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

An interventional study of Pre-operative education and Pos-operative rehabilitation in Knee Arthropathy, sponsored by University of the State of Santa Catarina. Completed at 1 site in Brazil. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-04-18.

Sponsored by University of the State of Santa Catarina · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
55 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Knee Arthropathy

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Keywords

  • patient education
  • arthritis
  • knee
  • arthroplasty
  • gait
03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 470 interventional studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

University of the State of Santa Catarina is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Patient education program

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

    Other: Pre-operative education · Other: Pos-operative rehabilitation

  • Active comparator
    Control - only pos-op rehabilitation

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

    Other: Pos-operative rehabilitation

Interventions

  • OtherPre-operative education

    Verbal and booklet about symptoms and physical conditions pos knee replacement

    Also known as: Patient education program

  • OtherPos-operative rehabilitation

    Physical therapy treatment

06

What researchers measure

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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

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

Other outcomes

  1. kinesiophobia

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

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

07

Study locations

1 site
  • Center for Health and Sport Sciences
    Florianópolis, Santa Catarina 88080350, Brazil
08

References and documents

Study documents

  • Informed consent form · Jul 24, 2017
  • Statistical analysis plan · Jul 24, 2017
  • Study protocol · Jul 26, 2017

Documents are hosted by the registry — open the source record to download them.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03230942
Lead sponsor
University of the State of Santa Catarina
Responsible party
Gilmar Moraes Santos (PhD, University of the State of Santa Catarina) — Principal investigator
First posted
Jul 27, 2017
Start date
Oct 1, 2017
Primary completion
Apr 30, 2018
Completion
Jul 30, 2018
Last update
Apr 18, 2019

Study contacts

Gilmar M Santos, PhD
principal investigator · University of State of Santa Catarina

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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