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

16. april 2019 opdateret af: Gilmar Moraes Santos, University of the State of Santa Catarina

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

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brasilien, 88080350
        • Center for Health and Sport Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

55 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Patient education program
Pre-operative education and pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
Andet: Pre-operative education
Verbal and booklet about symptoms and physical conditions pos knee replacement
Andre navne:
  • Patient education program
Andet: Pos-operative rehabilitation
Physical therapy treatment
Aktiv komparator: Control - only pos-op rehabilitation
Pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
Andet: Pos-operative rehabilitation
Physical therapy treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Timed up And Go Test score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
EMG activity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
kinesiophobia
Tidsramme: pre-operative; 6 weeks; 6 months
Fear of movement. The variable will be measured in points (score).
pre-operative; 6 weeks; 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of the State of Santa Catarina

Efterforskere

  • Ledende efterforsker: Gilmar M Santos, PhD, University of State of Santa Catarina

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2017

Primær færdiggørelse (Faktiske)

30. april 2018

Studieafslutning (Faktiske)

30. juli 2018

Datoer for studieregistrering

Først indsendt

24. juli 2017

Først indsendt, der opfyldte QC-kriterier

25. juli 2017

Først opslået (Faktiske)

27. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UDESantaCatarina

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