- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05248854
Effects of Sensorimotor and Core Stabilization Exercises After Total Knee Arthroplasty
Effects of Sensorimotor and Core Stabilization Exercise Programs Following Total Knee Arthroplasty : A Randomize Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Yeditepe University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Sensorimotor exercise training
SM program included combination of traditional hip and knee exercise, various balance and proprioceptive exercises.
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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:
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Experimental: Core Stabilization exercise training
Core stabilization exercise program contained traditional hip and knee ROM exercise combining the core stabilization as mat activities
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Proprioception
Time Frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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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
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change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Range of motion (ROM)
Time Frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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The ROM of knee and hip joints were assessed bilaterally via a universal goniometer.
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change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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Sit to Stand Test
Time Frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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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
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change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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Timed up and Go Test
Time Frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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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.
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change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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Berg Balance Test
Time Frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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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
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change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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KOOS Scale
Time Frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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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
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change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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Tampa Scale of Kinesiophobia
Time Frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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Consist of 17 items, evaluate the fear of movement.
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change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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Oswestry Low Back Disability Questionnaire
Time Frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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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.
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change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Emrah DEMİRBAŞ, Operator, Tuzla Gispir Hospital
- Study Chair: Şule BADILLI HANTAL, PhD, Yeditepe University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YeditepeUPT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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