Arthroplasty ComplicationsNCT04433962
Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty
A study testing Exercise training in people with Arthroplasty Complications and Physical Disability, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to investigate the effects of balance training in patients with THA until 26 weeks postoperatively. Thirty-two patients with hip osteoarthritis who were candidates for THA were recruited to the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroplasty Complications, Physical Disability, Osteoarthritis, Hip
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2014to 25 Dec 2016
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Total hip arthroplasty due to osteoarthritis
- First time hip surgery/prothesis
- no involvement in any exercise program in the past 12 months
Who cannot join
- THA due to hip fracture,
- revision hip prothesis,
- arthritis in other joints limited function
- neurologic problems that limited function and balance,
- body mass index greater than 40 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of balance training in patients with THA until 26 weeks postoperatively. Thirty-two patients with hip osteoarthritis who were candidates for THA were recruited to the study. Sixteen patients with THA completed the study protocol and the patients were randomized into 2 groups: conventional rehabilitation (CR, n=8) or conventional rehabilitation plus balance training (CR + BT, n=8) groups. The patients were evaluated by hand-held dynamometer, single leg stance test (SLST), Tetrax balance system, Harris hip score, lower extremity function scale, 5 times sit-to-stand test and 50 foot timed walk test preoperatively and in the 8th, 14th and 26th weeks postoperatively.
- Being tested
- Exercise training
- Keywords
- osteoarthritis, hip, total hip arthroplasty, balance training, function, assessment
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Also called conventional rehabilitation, conventional rehabilitation and balance training
| Study group | Role | What they receive |
|---|---|---|
| conventional rehabilitation group | Active comparator | the conventional rehabilitation group completed hip joint range of motion and muscle strengthening exercises Receives: Other: Exercise training |
| conventional rehabilitation + balance training group | Experimental | The conventional rehabilitation + balance training group completed hip joint range of motion and muscle strengthening exercises and 12 balance exercises. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
single leg test
Patients were tested first with eyes opened and then with eyes closed; they were asked to stand on either their left or right leg and tried to keep their legs from touching and to maintain single-leg stance for as long as possible. The test and time began once the foot was lifted off the floor, and ended when placing the lifted foot on the floor or with arm movements. The test was terminated following a maximum of 45 s, and each leg was tested three times with eyes opened and eyes closed and the best of the three trials were recorded
Measured: Pre-op to post-op 26. week
Tetrax Balance Assessment
Tetrax Balance Assessment System (Sunlight Medical Ltd.Ramat Gan, Israel); is a valid, reliable and objective method to evaluate balance and fall risk. The system obtains data by using 4 different platforms which measure vertical pressure fluctuations arising from two heels and two fingertips. Patients were instructed an immobile posture for 32 s for each of the eight sensory conditions.The fall risks of the patients were calculated as percentage (%) by a posturographic program considering the oscillation rates. A value between 0% and 36% is judged as mild risk; a value between 37% and 58%, as moderate risk; and between 59% and 100%, as high risk. The higher score is showed the greater falling risk
Measured: Pre-op to post-op 26. week
Sit to stand test
STS; is an objective functional measure of strength correlating with ambulatory independence. Sit-to-stand (such as the 5 STS) activities are recommended as the minimal core set of performance-based outcome measures in OA research and clinical practice [21]. Patients sit on a height adjustable chair such that a 90⁰ angle is formed when the femur is horizontal and tibia vertical with their feet shoulder width apart and their arms crossed against their chest. Patients are timed as they 5 times stand up from chair and sit down again without using their hand, time was recorded as second
Measured: Pre-op to post-op 26. week
50 feet walk test
50 FWT; is a reliable measurement method and commonly used in studies of exercise based OA. All patients are asked to walk as quickly as possible in 50 feet length distance. The physiotherapist counted number of steps and as soon as the patient finished to walking 50 feet length distance and the time was recorded as seconds
Measured: Pre-op to post-op 26. week
Harris hip score
Many different hip scoring scales are used in assessment of THA's results [23]. HHS is a joint specific outcome measurements and the most frequently used in assessment of THA patients. It has been used in a number of studies over the years and has been shown to have high validity and reliability [23,24]. HHS was recorded, a score commonly used in this context, which contains questions about pain, function, absence of deformity, and range-of-motion. The best possible score is 100 points
Measured: Pre-op to post-op 26. week
Lower extremity function scale
is a region specific measure, was conceived to assess the lower extremity functional status of patients and the reliability estimates have been high when investigated in the THA and TKA population. The LEFS is composed of 20 items each scored on a 5 point adjectival scale with '0' extreme difficulty or unable to perform the activity and '4' no difficulty. The items are summed to produce a total LEFS score, which can vary from 0 to 80.
Measured: Pre-op to post-op 26. week
Secondary outcomes (3)
Pain assessment
Visual analog scale was used to determine to degree of pain. The patient was asked to choose a number 0 and 10 on a chart. 0 indicates "no pain" and 10 indicates "very severe pain".
Measured: Pre-op to post-op 26. week
Range of motion
Hip extension, hipflexion, hip abduction and hip adduction was measured with goniometer.
Measured: Pre-op to post-op 26. week
Muscle strength
Maximal isometric muscle strength was measured with a handheld dynamometer (HHD) (Lafayette Instrument Company).
Measured: Pre-op to post-op 26. week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Sep 2014
- Primary completion20 Oct 2015
- Study completion25 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuray Elibol, Ege University
- Investigators
- Nuray Elibol, PhD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433962
- Sponsor's protocol ID
- 2012/22-01
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Balance Training on Balance and Functional Status Patients With Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04433962
- Acronym / sponsor ID
- 2012/22-01
- Keywords
- osteoarthritis, hip, total hip arthroplasty, balance training, function, assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 20 Oct 2015 (actual)
- Study completion
- 25 Dec 2016 (actual)
- First posted
- 16 Jun 2020 (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.
The purpose of this study is to investigate the effects of balance training in patients with THA until 26 weeks postoperatively. Thirty-two patients with hip osteoarthritis who were candidates for THA were recruited to the study. Sixteen patients with THA completed the study protocol and the patients were randomized into 2 groups: conventional rehabilitation (CR, n=8) or conventional rehabilitation plus balance training (CR + BT, n=8) groups. The patients were evaluated by hand-held dynamometer, single leg stance test (SLST), Tetrax balance system, Harris hip score, lower extremity function scale, 5 times sit-to-stand test and 50 foot timed walk test preoperatively and in the 8th, 14th and 26th weeks postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional rehabilitation group | Active comparator | Other: Exercise trainingthe conventional rehabilitation group completed hip joint range of motion and muscle strengthening exercises |
| conventional rehabilitation + balance training group | Experimental | Other: Exercise trainingThe conventional rehabilitation + balance training group completed hip joint range of motion and muscle strengthening exercises and 12 balance exercises. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total hip arthroplasty due to osteoarthritis
- First time hip surgery/prothesis
- no involvement in any exercise program in the past 12 months
Key exclusion criteria (5 listed)
- THA due to hip fracture,
- revision hip prothesis,
- arthritis in other joints limited function
- neurologic problems that limited function and balance,
- body mass index greater than 40 kg/m2.
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 |
|---|---|---|
| Exercise trainingAlso: conventional rehabilitation, conventional rehabilitation and balance training | Other | conventional rehabilitation + balance training group, conventional rehabilitation group |
Primary outcome
single leg test
Time frame: Pre-op to post-op 26. week
Patients were tested first with eyes opened and then with eyes closed; they were asked to stand on either their left or right leg and tried to keep their legs from touching and to maintain single-leg stance for as long as possible. The test and time began once the foot was lifted off the floor, and ended when placing the lifted foot on the floor or with arm movements. The test was terminated following a maximum of 45 s, and each leg was tested three times with eyes opened and eyes closed and the best of the three trials were recorded
Tetrax Balance Assessment
Time frame: Pre-op to post-op 26. week
Tetrax Balance Assessment System (Sunlight Medical Ltd.Ramat Gan, Israel); is a valid, reliable and objective method to evaluate balance and fall risk. The system obtains data by using 4 different platforms which measure vertical pressure fluctuations arising from two heels and two fingertips. Patients were instructed an immobile posture for 32 s for each of the eight sensory conditions.The fall risks of the patients were calculated as percentage (%) by a posturographic program considering the oscillation rates. A value between 0% and 36% is judged as mild risk; a value between 37% and 58%, as moderate risk; and between 59% and 100%, as high risk. The higher score is showed the greater falling risk
Sit to stand test
Time frame: Pre-op to post-op 26. week
STS; is an objective functional measure of strength correlating with ambulatory independence. Sit-to-stand (such as the 5 STS) activities are recommended as the minimal core set of performance-based outcome measures in OA research and clinical practice [21]. Patients sit on a height adjustable chair such that a 90⁰ angle is formed when the femur is horizontal and tibia vertical with their feet shoulder width apart and their arms crossed against their chest. Patients are timed as they 5 times stand up from chair and sit down again without using their hand, time was recorded as second
50 feet walk test
Time frame: Pre-op to post-op 26. week
50 FWT; is a reliable measurement method and commonly used in studies of exercise based OA. All patients are asked to walk as quickly as possible in 50 feet length distance. The physiotherapist counted number of steps and as soon as the patient finished to walking 50 feet length distance and the time was recorded as seconds
Harris hip score
Time frame: Pre-op to post-op 26. week
Many different hip scoring scales are used in assessment of THA's results [23]. HHS is a joint specific outcome measurements and the most frequently used in assessment of THA patients. It has been used in a number of studies over the years and has been shown to have high validity and reliability [23,24]. HHS was recorded, a score commonly used in this context, which contains questions about pain, function, absence of deformity, and range-of-motion. The best possible score is 100 points
Lower extremity function scale
Time frame: Pre-op to post-op 26. week
is a region specific measure, was conceived to assess the lower extremity functional status of patients and the reliability estimates have been high when investigated in the THA and TKA population. The LEFS is composed of 20 items each scored on a 5 point adjectival scale with '0' extreme difficulty or unable to perform the activity and '4' no difficulty. The items are summed to produce a total LEFS score, which can vary from 0 to 80.
3 secondary outcomes
Pain assessment
Time frame: Pre-op to post-op 26. week
Range of motion
Time frame: Pre-op to post-op 26. week
Muscle strength
Time frame: Pre-op to post-op 26. week
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 16 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Nuray Elibol, PhD principal investigator
Ege 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 Exercise training in people with Arthroplasty Complications and Physical Disability, run by Ege 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 5 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 16 Jun 2020. 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?
single leg test (time frame: Pre-op to post-op 26. week). The study lists 6 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 16 Jun 2020.