- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03230942
Effect of Pre-op Patient Education on Functional Outcomes After TKA
Effect of Pre-operative Patient Education Program on Functional Outcomes After Total Knee Arthroplasty
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Santa Catarina
-
Florianópolis, Santa Catarina, Brésil, 88080350
- Center for Health and Sport Sciences
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Patient education program
Pre-operative education and pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
|
Verbal and booklet about symptoms and physical conditions pos knee replacement
Autres noms:
Physical therapy treatment
|
|
Comparateur actif: Control - only pos-op rehabilitation
Pos-operative rehabilitation in individuals will be undergo knee arthroplasty.
|
Physical therapy treatment
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Timed up And Go Test score
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
EMG activity
Délai: 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
Délai: 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
Délai: 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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
kinesiophobia
Délai: pre-operative; 6 weeks; 6 months
|
Fear of movement.
The variable will be measured in points (score).
|
pre-operative; 6 weeks; 6 months
|
Collaborateurs et enquêteurs
Les enquêteurs
- Chercheur principal: Gilmar M Santos, PhD, University of State of Santa Catarina
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UDESantaCatarina
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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