the Methodology of the Balance TestNCT05703594
Analyzing of the Reliability, Validity and Responsiveness Levels of Performance Tests
A study testing performance based balance test in people with the Methodology of the Balance Test, run by Dokuz Eylul University.
Trial summary
Purpose: To examine the validity, reliability and responsiveness of three performance tests evaluating fall risk and balance in patients undergoing total knee arthroplasty (TKA). Method: At least 50 patients with TKA will be included in the study. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- the Methodology of the Balance Test
- What is being tested?
- performance based balance test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 May 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having primary total knee arthroplasty (TKA) for knee osteoarthritis
- Having completed at least 6 months after primary TKA
- Being able to stand and walk without the need for any assistive device
- Being able to understand written or spoken commands
- Having grade 3-4 radiological knee osteoarthritis
Who cannot join
- Other existing pain problem or central or peripheral nervous system condition causing sensory dysfunction (eg stroke, multiple sclerosis, spinal cord disorders or peripheral nerve lesion)
- Different lower extremity surgeries before or after primary TKA
- Neurological or orthopedic disorder that may affect gait and balance
- Other unstable diseases (eg cancer, acute trauma or infection)
- Presence of inflammatory arthritis or other systemic connective tissue disease
- Those who have lost their walking function
- Body mass index > 40 (morbidly obese)
About this study
Official title: Analyzing of the Reliability, Validity and Responsiveness Levels of Performance Tests Assessing Fall Risk and Balance in Patients Undergoing Total Knee Arthroplasty
Purpose: To examine the validity, reliability and responsiveness of three performance tests evaluating fall risk and balance in patients undergoing total knee arthroplasty (TKA).
Method: At least 50 patients with TKA will be included in the study. Participants will be voluntary individuals who meet the inclusion criteria. Within the scope of the evaluations, the duration of the patients to perform the 360° Turn Test (360°TT), Alternative Step Test (AST), and Pen Pickup Test (PPT) will be measured. These tests will be repeated after the patients rest for 1 hour. Hospital For Special Surgery (HSS) Knee Score to determine the functional level of patients, Timed Up and Go Test (TUGT) to determine fall risk and balance status, 5-Repeat Stand Up and Sit Test (5RSST) and 10-meter Walk Test (10MWT) will be used. In addition, the fall history of the patients will be questioned. For the construct validity of the 360°TT, AST and PPT tests, it will be investigated whether at least 75% of the predetermined hypotheses are met. For the discriminative validity of the 360°TT, AST and PPT tests, the values in the homogeneous demographic patient population with grade 3-4 knee osteoarthritis and the patient population undergoing knee arthroplasty will be compared and cut-off values will be calculated. In addition, sensitivity and specificity values will be calculated. In addition, test values will be compared and cut-off values will be calculated in patients who have undergone knee arthroplasty with and without a history of falling. In addition, sensitivity and specificity values will be calculated. Reliability will be examined by examining the test-retest intra-class correlation. In addition, in order to examine the responsiveness of the tests, patients will be taught lower extremity strengthening exercises and balance exercises in the form of a home program after the initial assessment. The second evaluation will be repeated between 6-8 weeks following the first evaluation, and the responsiveness of the tests will be determined according to the average change in the outcome measurements and the fulfillment of the hypotheses.
Read the detailed description
Hospital For Special Surgery (HSS) Knee Scoring This scoring includes the parameters of pain (30 points), function (22 points), range of motion (18 points), muscle strength (10 points), knee joint flexion deformity (10 points), instability (10 points) and a total of 100 points. The HSS score is obtained by subtracting up to 3 points for walking aids, up to 5 points for loss of extension, and 1 point for each 5 degree varus/valgus angle from the total score. The score ranges obtained are classified as excellent for 85-100 points, good for 70-84 points, moderate for 60-69 points, and bad for less than 60 points.
360° Turn Test In this test, which is used to measure dynamic balance, the participant rotates 360° all round. The time the participant completes the turn and the number of steps are recorded. If the cut-off value is > 3.8 seconds in the elderly population, there is a risk of falling.
Alternative Step Test It is a test used to test body weight transfer and lateral stability. The participant -height 18 cm, width 60 cm, width 40 cm- comes into contact with the sole of the foot in rows of right and left. A total of 8 step times, 4 right and 4 left, are recorded in seconds.
Pen Pickup Test In this test, in which mobility, flexibility and dynamic balance are evaluated, the participant bends down and picks up a pencil 30 cm from the tip of the foot while standing and comes back to the upright position. The duration of the movement is recorded in seconds.
Timed Get Up and Go Test It is a physical performance test often used to assess fall risk and balance. The participant gets up from a standard-height chair without support, returns after walking 3 meters, and sits down again without support. The time is saved. A value > 14 sec is considered a fall risk. Its validity and reliability have been demonstrated in different populations.
5 Repetitive Stand Up and Sit Test (5RSST) It is a performance test in which the dynamic balance is evaluated by recording the performance of people getting up and sitting in a standard chair 5 times in a series of time.
10 Meter Walk Test (10MWT) It is a performance test in which dynamic balance is evaluated by recording the 10-meter walking performance of individuals in terms of time.
- Conditions
- the Methodology of the Balance Test
- Being tested
- performance based balance test
- Keywords
- balance, total knee arthroplasty, test, reliability, validity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
performance based balance testDiagnostic test
Also called lower extremity strengthening exercises, balance exercises
Performance based balance test; 360° Turn Test, Alternative Step Test, Pen Pickup Test,5 Repetitive Stand Up and Sit Test, 10 Meter Walk Test Lower extremity strengthening exercises; Quadriceps femoris strengthening exercise Hamstring strengthening exercise Gluteus medius muscle strengthening exercise Strengthening exercise for hip adductor muscles Balance exercises; Standing tandem walk Standing side walks Standing cross walks Standing back walking
| Study group | Role | What they receive |
|---|---|---|
| Dokuz Eylul University | Other | Dokuz Eylul University Clinic Receives: Diagnostic Test: performance based balance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
360° Turn Test
In this test, which is used to measure dynamic balance, the participant rotates 360° all round. The time the participant completes the turn and the number of steps are recorded. If the cut-off value is > 3.8 seconds in the elderly population, there is a risk of falling.
Measured: up to 2 months
Alternative Step Test
It is a test used to test body weight transfer and lateral stability. The participant -height 18 cm, width 60 cm, width 40 cm- comes into contact with the sole of the foot in rows of right and left. A total of 8 step times, 4 right and 4 left, are recorded in seconds.
Measured: up to 2 months
Pen Pickup Test
In this test, in which mobility, flexibility and dynamic balance are evaluated, the participant bends down and picks up a pencil 30 cm from the tip of the foot while standing and comes back to the upright position. The duration of the movement is recorded in seconds.
Measured: up to 2 months
Secondary outcomes (4)
Timed Up and Go Test
It is a physical performance test often used to assess fall risk and balance. The participant gets up from a standard-height chair without support, returns after walking 3 meters, and sits down again without support. The time is saved. A value > 14 sec is considered a fall risk. Its validity and reliability have been demonstrated in different populations.
Measured: up to 2 months
5 Repetitive Stand Up and Sit Test
It is a performance test in which the dynamic balance is evaluated by recording the performance of people getting up and sitting in a standard chair 5 times in a series of time.
Measured: up to 2 months
10 Meter Walk Test
It is a performance test in which dynamic balance is evaluated by recording the 10-meter walking performance of individuals in terms of time.
Measured: up to 2 months
Hospital For Special Surgery (HSS) Knee Scoring
This scoring includes the parameters of pain (30 points), function (22 points), range of motion (18 points), muscle strength (10 points), knee joint flexion deformity (10 points), instability (10 points) and a total of 100 points. The HSS score is obtained by subtracting up to 3 points for walking aids, up to 5 points for loss of extension, and 1 point for each 5 degree varus/valgus angle from the total score. The score ranges obtained are classified as excellent for 85-100 points, good for 70-84 points, moderate for 60-69 points, and bad for less than 60 points.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Methodology of the Balance TestStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective methodological study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacı Ahmet YARAR, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703594
- Sponsor's protocol ID
- 0000-0003-2719-3255
- Status last verified
- Jan 2023
- First submitted
- 29 Dec 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not consider data sharing
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing of the Reliability, Validity and Responsiveness Levels of Performance Tests Assessing Fall Risk and Balance in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05703594
- Acronym / sponsor ID
- 0000-0003-2719-3255
- Conditions
- the Methodology of the Balance Test
- Keywords
- balance, total knee arthroplasty, test, reliability, validity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 30 Jan 2023 (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.
Purpose: To examine the validity, reliability and responsiveness of three performance tests evaluating fall risk and balance in patients undergoing total knee arthroplasty (TKA).
Method: At least 50 patients with TKA will be included in the study. Participants will be voluntary individuals who meet the inclusion criteria. Within the scope of the evaluations, the duration of the patients to perform the 360° Turn Test (360°TT), Alternative Step Test (AST), and Pen Pickup Test (PPT) will be measured. These tests will be repeated after the patients rest for 1 hour. Hospital For Special Surgery (HSS) Knee Score to determine the functional level of patients, Timed Up and Go Test (TUGT) to determine fall risk and balance status, 5-Repeat Stand Up and Sit Test (5RSST) and 10-meter Walk Test (10MWT) will be used. In addition, the fall history of the patients will be questioned. For the construct validity of the 360°TT, AST and PPT tests, it will be investigated whether at least 75% of the predetermined hypotheses are met. For the discriminative validity of the 360°TT, AST and PPT tests, the values in the homogeneous demographic patient population with grade 3-4 knee osteoarthritis and the patient population undergoing knee arthroplasty will be compared and cut-off values will be calculated. In addition, sensitivity and specificity values will be calculated. In addition, test values will be compared and cut-off values will be calculated in patients who have undergone knee arthroplasty with and without a history of falling. In addition, sensitivity and specificity values will be calculated. Reliability will be examined by examining the test-retest intra-class correlation. In addition, in order to examine the responsiveness of the tests, patients will be taught lower extremity strengthening exercises and balance exercises in the form of a home program after the initial assessment. The second evaluation will be repeated between 6-8 weeks following the first evaluation, and the responsiveness of the tests will be determined according to the average change in the outcome measurements and the fulfillment of the hypotheses.
Detailed description
Hospital For Special Surgery (HSS) Knee Scoring This scoring includes the parameters of pain (30 points), function (22 points), range of motion (18 points), muscle strength (10 points), knee joint flexion deformity (10 points), instability (10 points) and a total of 100 points. The HSS score is obtained by subtracting up to 3 points for walking aids, up to 5 points for loss of extension, and 1 point for each 5 degree varus/valgus angle from the total score. The score ranges obtained are classified as excellent for 85-100 points, good for 70-84 points, moderate for 60-69 points, and bad for less than 60 points.
360° Turn Test In this test, which is used to measure dynamic balance, the participant rotates 360° all round. The time the participant completes the turn and the number of steps are recorded. If the cut-off value is > 3.8 seconds in the elderly population, there is a risk of falling.
Alternative Step Test It is a test used to test body weight transfer and lateral stability. The participant -height 18 cm, width 60 cm, width 40 cm- comes into contact with the sole of the foot in rows of right and left. A total of 8 step times, 4 right and 4 left, are recorded in seconds.
Pen Pickup Test In this test, in which mobility, flexibility and dynamic balance are evaluated, the participant bends down and picks up a pencil 30 cm from the tip of the foot while standing and comes back to the upright position. The duration of the movement is recorded in seconds.
Timed Get Up and Go Test It is a physical performance test often used to assess fall risk and balance. The participant gets up from a standard-height chair without support, returns after walking 3 meters, and sits down again without support. The time is saved. A value > 14 sec is considered a fall risk. Its validity and reliability have been demonstrated in different populations.
5 Repetitive Stand Up and Sit Test (5RSST) It is a performance test in which the dynamic balance is evaluated by recording the performance of people getting up and sitting in a standard chair 5 times in a series of time.
10 Meter Walk Test (10MWT) It is a performance test in which dynamic balance is evaluated by recording the 10-meter walking performance of individuals in terms of time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective methodological study
| Arm | Type | Receives |
|---|---|---|
| Dokuz Eylul University | Other | Diagnostic Test: performance based balance testDokuz Eylul University Clinic |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Having primary total knee arthroplasty (TKA) for knee osteoarthritis
- Having completed at least 6 months after primary TKA
- Being able to stand and walk without the need for any assistive device
- Being able to understand written or spoken commands
- Having grade 3-4 radiological knee osteoarthritis
Key exclusion criteria (7 listed)
- Other existing pain problem or central or peripheral nervous system condition causing sensory dysfunction (eg stroke, multiple sclerosis, spinal cord disorders or peripheral nerve lesion)
- Different lower extremity surgeries before or after primary TKA
- Neurological or orthopedic disorder that may affect gait and balance
- Other unstable diseases (eg cancer, acute trauma or infection)
- Presence of inflammatory arthritis or other systemic connective tissue disease
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 |
|---|---|---|
| performance based balance testAlso: lower extremity strengthening exercises, balance exercisesPerformance based balance test; 360° Turn Test, Alternative Step Test, Pen Pickup Test,5 Repetitive Stand Up and Sit Test, 10 Meter Walk Test Lower extremity strengthening exercises; Quadriceps femoris strengthening exercise Hamstring strengthening exercise Gluteus medius muscle strengthening exercise Strengthening exercise for hip adductor muscles Balance exercises; Standing tandem walk Standing side walks Standing cross walks Standing back walking | Diagnostic test | Dokuz Eylul University |
Primary outcome
360° Turn Test
Time frame: up to 2 months
In this test, which is used to measure dynamic balance, the participant rotates 360° all round. The time the participant completes the turn and the number of steps are recorded. If the cut-off value is > 3.8 seconds in the elderly population, there is a risk of falling.
Alternative Step Test
Time frame: up to 2 months
It is a test used to test body weight transfer and lateral stability. The participant -height 18 cm, width 60 cm, width 40 cm- comes into contact with the sole of the foot in rows of right and left. A total of 8 step times, 4 right and 4 left, are recorded in seconds.
Pen Pickup Test
Time frame: up to 2 months
In this test, in which mobility, flexibility and dynamic balance are evaluated, the participant bends down and picks up a pencil 30 cm from the tip of the foot while standing and comes back to the upright position. The duration of the movement is recorded in seconds.
4 secondary outcomes
Timed Up and Go Test
Time frame: up to 2 months
5 Repetitive Stand Up and Sit Test
Time frame: up to 2 months
10 Meter Walk Test
Time frame: up to 2 months
Hospital For Special Surgery (HSS) Knee Scoring
Time frame: up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No. We do not consider data sharing
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing performance based balance test in people with the Methodology of the Balance Test, run by Dokuz Eylul University.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
360° Turn Test (time frame: up to 2 months). The study lists 3 primary outcomes in all. 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 30 Jan 2023.