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

NCT ID: NCT03230942

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2018-07-30

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.

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.

Conditions

Knee Arthropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Patient education program

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

Group Type: EXPERIMENTAL

Pre-operative education

Intervention Type: OTHER

Verbal and booklet about symptoms and physical conditions pos knee replacement

Pos-operative rehabilitation

Intervention Type: OTHER

Physical therapy treatment

Control - only pos-op rehabilitation

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

Group Type: ACTIVE_COMPARATOR

Pos-operative rehabilitation

Intervention Type: OTHER

Physical therapy treatment

Interventions

Pre-operative education

Verbal and booklet about symptoms and physical conditions pos knee replacement

Intervention Type: OTHER

Pos-operative rehabilitation

Physical therapy treatment

Intervention Type: OTHER

Other Intervention Names

Patient education program

Eligibility Criteria

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of the State of Santa Catarina

OTHER

Sponsor Role: lead

Responsible Party

Gilmar Moraes Santos

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilmar M Santos, PhD

Role: PRINCIPAL_INVESTIGATOR

University of State of Santa Catarina

Locations

Center for Health and Sport Sciences

Florianópolis, Santa Catarina, Brazil

Countries

Brazil

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

UDESantaCatarina

Identifier Type: -

Identifier Source: org_study_id