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Effects of Sensorimotor and Core Stabilization Exercises After Total Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis, Arthroplasty, Joint Replacement

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sensorimotor exercise training
Core stabilization exercise training
Sponsored by
Yeditepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring total knee replacement, arthroplasty, balance, core stabilization, sensorimotor training

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • being volunteer,
  • 50-85 age range,
  • being diagnosed with unilateral OA and undergoing unilateral TKA surgery

Exclusion Criteria:

  • having previous surgery history of lower limbs,
  • impaired hearing-vision -verbal problems, physical or mental disability,
  • having a neurological or oncologic disease that may affect functional performance.

Sites / Locations

  • Yeditepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sensorimotor exercise training

Core Stabilization exercise training

Arm Description

SM program included combination of traditional hip and knee exercise, various balance and proprioceptive exercises.

Core stabilization exercise program contained traditional hip and knee ROM exercise combining the core stabilization as mat activities

Outcomes

Primary Outcome Measures

Proprioception
Joint Position Sense(JPS) was assessed to proprioception. JPS was evaluated via ability to reproduce joint angles using position-matching with active or passive movements (21, 22). Therapist showed each reference 30 and 60 degree flexion angles passively three times, held it for 10 second and returned to starting position during sitting. Then, patients were asked to show the target angles with eyes-closed, three deviated angles were recorded and the mean of errors was used for statistics

Secondary Outcome Measures

Range of motion (ROM)
The ROM of knee and hip joints were assessed bilaterally via a universal goniometer.
Sit to Stand Test
The STS test was applied by recording the elapsed time between the patients who were asked to sit and stand up 5 times as fast as possible
Timed up and Go Test
In the TUG test, patients were asked to stand up independently from the chair, walk 3 m, turn around and sit at the starting point; the time elapsed between them was recorded (25). The minimum 2.49 seconds change indicates good clinical properties and below the 14 sec during performance indicate higher risk of falling.
Berg Balance Test
Berg Balance Test was also used to assess the static balance and falling risk of the participants. The test includes 14 different tasks scored between 0-4 points. Total scores were recorded between 0-56 points, higher score indicates better balance level
KOOS Scale
KOOS consists of 42 items and five subscales: pain, symptom, activities of daily life, quality of life, sport and recreation. All questions are scored 0-4 points and subscales points are converted separately to 0-100 points. Higher point indicates no knee problems
Tampa Scale of Kinesiophobia
Consist of 17 items, evaluate the fear of movement.
Oswestry Low Back Disability Questionnaire
The Oswestry Disability Index is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

Full Information

First Posted
January 11, 2022
Last Updated
February 28, 2023
Sponsor
Yeditepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05248854
Brief Title
Effects of Sensorimotor and Core Stabilization Exercises After Total Knee Arthroplasty
Official Title
Effects of Sensorimotor and Core Stabilization Exercise Programs Following Total Knee Arthroplasty : A Randomize Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2019 (Actual)
Primary Completion Date
May 16, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yeditepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Tha aim of the study is to investigate the effects of core stabilization and sensorimotor exercise program on range of motion, proprioception, balance and functional status in patients with total knee arthroplasty. The study lasts prospective randomized controlled trial. Participants were randomly divided into sensorimotor training (SM,n=17) and core stabilization training group (CS,n=19). The exercise training program was administered for home exercise as 3-5 times a week and for a 6-week duration.
Detailed Description
Objective : To investigate the effects of core stabilization and sensorimotor exercise program on range of motion, proprioception, balance and functional status in patients with total knee arthroplasty. Design : Prospective randomized controlled trial Subjects : A total of 36 Ostearthritis patients (69.8 ± 5.1 years) who underwent unilateral knee arthroplasty. Participants were performed TKA surgery by the same physician and followed by the same therapist. The following inclusion criteria were used: being volunteer, 50-85 age range, being diagnosed with stage 4 OA and undergoing unilateral TKA surgery. The following exclusion criteria were applied: having previous surgery history of affected lower limb, impaired hearing, vision or verbal problems, physical or mental disability, having a neurological or oncologic disease that may affect functional performance. Patients who met inclusion criteria and were willing to join the study (n=52) were evaluated after being diagnosed with OA and before the operation at the clinic. A total 40 patients undergoing TKA surgery participated in our study and were randomly separated to the Sensorimotor Training Group (SM, n=20) and the Core Stabilization Training Group (CS, n=20). Group allocation was randomized in two blocks of 40 sealed envelopes without external marks, which were mixed and numbered from 1 to 40, containing a piece of paper with the group allocation. All participants were blinded to the treatment type. As a result, 36 patients completed the process. Outcome Measures : Patients were assessed on three separate occasions (presurgery, 2 weeks and 8 weeks postsurgery). The primary outcome was proprioception and seconder outcomes were range of motion, Knee Injury and Osteoarthritis Outcome Scale (KOOS), Berg Balance Test, Timed-up & Go test and Sit & Stand -Up tests. Interventions : Participants were randomized into two intervention groups: sensorimotor training group (SM, n=17) and Core Stabilization training group (CS, n=19). Both groups were prescribed a 6-week home based exercise programme for 3-5 sessions/week between 2 and 8 weeks postsurgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Arthroplasty, Joint Replacement
Keywords
total knee replacement, arthroplasty, balance, core stabilization, sensorimotor training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial , prospective, single bllinded.
Masking
Participant
Masking Description
Participants did not know the their grup.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensorimotor exercise training
Arm Type
Experimental
Arm Description
SM program included combination of traditional hip and knee exercise, various balance and proprioceptive exercises.
Arm Title
Core Stabilization exercise training
Arm Type
Experimental
Arm Description
Core stabilization exercise program contained traditional hip and knee ROM exercise combining the core stabilization as mat activities
Intervention Type
Other
Intervention Name(s)
Sensorimotor exercise training
Other Intervention Name(s)
SM exercises
Intervention Description
The program included side stepping, tandem walking, perturbation exercise, overcoming mini obstacles, walking different surfaces and traditional hip and knee exercise. Participants applied these exercise as home program between postoperative second weeks and 8th weeks, 3-5 day /week , 20 25 min every session.
Intervention Type
Other
Intervention Name(s)
Core stabilization exercise training
Other Intervention Name(s)
CS exercises
Intervention Description
Core stabilization exercise program was also prepared parallel to the sensorimotor training group intensity; the program contained traditional hip and knee exercise combining the core stabilization as mat activities depending on previous research.core stabilization exercise program was also prepared parallel to the sensorimotor training group intensity; the program contained traditional hip and knee exercise combining the core stabilization as mat activities depending on previous research
Primary Outcome Measure Information:
Title
Proprioception
Description
Joint Position Sense(JPS) was assessed to proprioception. JPS was evaluated via ability to reproduce joint angles using position-matching with active or passive movements (21, 22). Therapist showed each reference 30 and 60 degree flexion angles passively three times, held it for 10 second and returned to starting position during sitting. Then, patients were asked to show the target angles with eyes-closed, three deviated angles were recorded and the mean of errors was used for statistics
Time Frame
change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Secondary Outcome Measure Information:
Title
Range of motion (ROM)
Description
The ROM of knee and hip joints were assessed bilaterally via a universal goniometer.
Time Frame
change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Title
Sit to Stand Test
Description
The STS test was applied by recording the elapsed time between the patients who were asked to sit and stand up 5 times as fast as possible
Time Frame
change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Title
Timed up and Go Test
Description
In the TUG test, patients were asked to stand up independently from the chair, walk 3 m, turn around and sit at the starting point; the time elapsed between them was recorded (25). The minimum 2.49 seconds change indicates good clinical properties and below the 14 sec during performance indicate higher risk of falling.
Time Frame
change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Title
Berg Balance Test
Description
Berg Balance Test was also used to assess the static balance and falling risk of the participants. The test includes 14 different tasks scored between 0-4 points. Total scores were recorded between 0-56 points, higher score indicates better balance level
Time Frame
change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Title
KOOS Scale
Description
KOOS consists of 42 items and five subscales: pain, symptom, activities of daily life, quality of life, sport and recreation. All questions are scored 0-4 points and subscales points are converted separately to 0-100 points. Higher point indicates no knee problems
Time Frame
change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Title
Tampa Scale of Kinesiophobia
Description
Consist of 17 items, evaluate the fear of movement.
Time Frame
change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Title
Oswestry Low Back Disability Questionnaire
Description
The Oswestry Disability Index is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.
Time Frame
change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: being volunteer, 50-85 age range, being diagnosed with unilateral OA and undergoing unilateral TKA surgery Exclusion Criteria: having previous surgery history of lower limbs, impaired hearing-vision -verbal problems, physical or mental disability, having a neurological or oncologic disease that may affect functional performance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emrah DEMİRBAŞ, Operator
Organizational Affiliation
Tuzla Gispir Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Şule BADILLI HANTAL, PhD
Organizational Affiliation
Yeditepe University
Official's Role
Study Chair
Facility Information:
Facility Name
Yeditepe University
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

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Effects of Sensorimotor and Core Stabilization Exercises After Total Knee Arthroplasty

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