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Completed

NCT Number: NCT05248854

Effects of Sensorimotor and Core Stabilization Exercises After Total Knee Arthroplasty

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Arthroplasty Joint Diseases Joint Replacement Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yeditepe University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sensorimotor exercise training

Other

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.

Other names: SM exercises

Core stabilization exercise training

Other

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

Other names: CS exercises

Primary outcomes

  1. Proprioception

    Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

    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 outcomes

  1. Range of motion (ROM)

    Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

    The ROM of knee and hip joints were assessed bilaterally via a universal goniometer.

  2. Sit to Stand Test

    Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

    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

  3. Timed up and Go Test

    Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

    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.

  4. Berg Balance Test

    Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

    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

  5. KOOS Scale

    Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

    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

  6. Tampa Scale of Kinesiophobia

    Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

    Consist of 17 items, evaluate the fear of movement.

  7. Oswestry Low Back Disability Questionnaire

    Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

    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.

Sponsors and collaborators

Lead sponsor

Yeditepe University

Other

Registry information

Official study title

Effects of Sensorimotor and Core Stabilization Exercise Programs Following Total Knee Arthroplasty : A Randomize Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 21, 2022
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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