Knee OsteoarthritisNCT05248854
Effects of Sensorimotor and Core Stabilization Exercises After Total Knee Arthroplasty
A study testing Sensorimotor exercise training and Core stabilization exercise training in people with Knee Osteoarthritis and Arthroplasty, run by Yeditepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Arthroplasty, Joint Replacement
- What is being tested?
- Sensorimotor exercise training and Core stabilization exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2019to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- being volunteer,
- 50-85 age range,
- being diagnosed with unilateral OA and undergoing unilateral TKA surgery
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Sensorimotor and Core Stabilization Exercise Programs Following Total Knee Arthroplasty : A Randomize Controlled Trial
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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Arthroplasty, Joint Replacement
- Being tested
- Sensorimotor exercise training, Core stabilization exercise training
- Keywords
- total knee replacement, arthroplasty, balance, core stabilization, sensorimotor training
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor exercise trainingOther
Also called SM exercises
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.
Core stabilization exercise trainingOther
Also called CS exercises
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
| Study group | Role | What they receive |
|---|---|---|
| Sensorimotor exercise training | Experimental | SM program included combination of traditional hip and knee exercise, various balance and proprioceptive exercises. Receives: Other: Sensorimotor exercise training |
| Core Stabilization exercise training | Experimental | Core stabilization exercise program contained traditional hip and knee ROM exercise combining the core stabilization as mat activities Receives: Other: Core stabilization exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Secondary outcomes (7)
Range of motion (ROM)
The ROM of knee and hip joints were assessed bilaterally via a universal goniometer.
Measured: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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
Measured: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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.
Measured: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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
Measured: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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
Measured: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Tampa Scale of Kinesiophobia
Consist of 17 items, evaluate the fear of movement.
Measured: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
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.
Measured: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start28 Nov 2019
- Primary completion16 May 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial , prospective, single bllinded.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emrah DEMİRBAŞ, Operator, Study chair, Tuzla Gispir HospitalŞule BADILLI HANTAL, PhD, Study chair, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248854
- Sponsor's protocol ID
- YeditepeUPT
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2022
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sensorimotor and Core Stabilization Exercise Programs Following Total Knee Arthroplasty : A Randomize Controlled Trial
- ClinicalTrials.gov ID
- NCT05248854
- Acronym / sponsor ID
- YeditepeUPT
- Conditions
- Knee Osteoarthritis, Arthroplasty, Joint Replacement
- Keywords
- total knee replacement, arthroplasty, balance, core stabilization, sensorimotor training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- 16 May 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized controlled trial , prospective, single bllinded.
| Arm | Type | Receives |
|---|---|---|
| Sensorimotor exercise training | Experimental | Other: Sensorimotor exercise trainingSM program included combination of traditional hip and knee exercise, various balance and proprioceptive exercises. |
| Core Stabilization exercise training | Experimental | Other: Core stabilization exercise trainingCore stabilization exercise program contained traditional hip and knee ROM exercise combining the core stabilization as mat activities |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being volunteer,
- 50-85 age range,
- being diagnosed with unilateral OA and undergoing unilateral TKA surgery
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensorimotor exercise trainingAlso: SM exercisesThe 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 | Sensorimotor exercise training |
| Core stabilization exercise trainingAlso: CS exercisesCore 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 | Core Stabilization exercise training |
Primary outcome
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
7 secondary outcomes
Range of motion (ROM)
Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Sit to Stand Test
Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Timed up and Go Test
Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Berg Balance Test
Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
KOOS Scale
Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Tampa Scale of Kinesiophobia
Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Oswestry Low Back Disability Questionnaire
Time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emrah DEMİRBAŞ, Operator study chair
Tuzla Gispir Hospital
Şule BADILLI HANTAL, PhD study chair
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensorimotor exercise training and Core stabilization exercise training in people with Knee Osteoarthritis and Arthroplasty, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proprioception (time frame: change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.