NCT03230942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

July 24, 2017

Last Update Submit

April 16, 2019

Conditions

Knee Arthropathy

Keywords

patient educationarthritiskneearthroplastygait

Outcome Measures

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.

    pre-operative; 6 weeks; 6 months

Secondary Outcomes (3)

  • EMG activity

    pre-operative; 6 weeks; 6 months

  • Kinematics

    pre-operative; 6 weeks; 6 months

  • Kinetics

    pre-operative; 6 weeks; 6 months

Other Outcomes (1)

  • kinesiophobia

    pre-operative; 6 weeks; 6 months

Study Arms (2)

Patient education program

EXPERIMENTAL

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

Other: Pre-operative educationOther: Pos-operative rehabilitation

Control - only pos-op rehabilitation

ACTIVE COMPARATOR

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

Other: Pos-operative rehabilitation

Interventions

Pre-operative educationOTHER

Verbal and booklet about symptoms and physical conditions pos knee replacement

Also known as: Patient education program
Patient education program
Pos-operative rehabilitationOTHER

Physical therapy treatment

Control - only pos-op rehabilitationPatient education program

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health and Sport Sciences

Florianópolis, Santa Catarina, 88080350, Brazil

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Gilmar M Santos, PhD

    University of State of Santa Catarina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All patients will be assessed for functional outcomes by a rater blinded to the study arm
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 27, 2017

Study Start

October 1, 2017

Primary Completion

April 30, 2018

Study Completion

July 30, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

BR(1)