Knee OsteoarthritisNCT05287802
The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis
A study testing Balance and proprioception exercises and Home exercises program in people with Knee Osteoarthritis and Balance; Distorted, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aime to investigate the effects of balance and proprioception exercises using two different methods (classical balance training and Balance System™ SD) in addition to strengthening exercises on dynamic balance, pain, functional status and quality of life in patients with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 to 70 years, women only
- Conditions the study is for
- Knee Osteoarthritis, Balance; Distorted, Proprioceptive Disorders
- What is being tested?
- Balance and proprioception exercises and Home exercises program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- May 2014to Jun 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 40 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were included if they had a knee OA diagnosis according to the American College of Rheumatology (ACR) diagnostic criteria, had suffered from knee pain for at least six months, had radiologically verified bilateral knee OA of grade II or III according to the Kellgren-Lawrence classification and had not previously participated in a regular exercise program.
Who cannot join
- Patients who had undergone knee surgery, who had received hyaluronic acid or corticosteroid injections into the knee within six months, and patients with conditions that might affect balance were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Research and Training Hostpital
Izmir
About this study
Official title: The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis: a Randomized Controlled Study
This study aime to investigate the effects of balance and proprioception exercises using two different methods (classical balance training and Balance System™ SD) in addition to strengthening exercises on dynamic balance, pain, functional status and quality of life in patients with knee osteoarthritis (OA).
Read the detailed description
It is known that knee OA leads to a decrease in proprioception and balance disturbances. Falls due to balance disorders often occur during dynamic activities such as walking and stair climbing. Therefore, correction of balance disorders is of great importance to prevent falls and associated fractures in the elderly population, in which knee OA is common. In addition, loss of proprioception in the knee joint, muscle weakness, and balance disorders are also known to contribute to the development of knee OA itself. Therefore, treatment of balance disorders may also slow the progression of the disease. This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This is a single-center randomized trial with 3 parallel arms.
- Being tested
- Balance and proprioception exercises, Home exercises program
- Medical subject headings
- Osteoarthritis, Knee, Somatosensory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance and proprioception exercisesOther
Balance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises
Home exercises programOther
Isometric exercises for the quadriceps and hamstrings at home
| Study group | Role | What they receive |
|---|---|---|
| Biodex Training (BT) group | Active comparator | Biodex Balance System features a platform that can move simultaneously in the anteroposterior (AP) or medio-lateral (ML) direction in 12 different levels of stability within a 20-degree range of inclination, as well as a locked position for static environments. For this platform, 1 represents the least stable level and 12 represents the most stable level. Interactive, game-like training modes are provided with the on-screen grid and score-keeping functions. Patients in the BT group performed exercises with the Balance SystemTM SD once a day, three days a week for 10 weeks under the physicians' supervision. Furthermore this group received closed kinetic chain exercises (CKCE) in addition to their own exercise program, which was applied in exactly the same way. The CKCE were performed in three sets of 10 repetitions with five seconds rest between each exercise. The exercises consisted of mini-squats, wall sits, and lunges. Receives: Other: Balance and proprioception exercises |
| Classical balance training group (CT group) | Active comparator | Patients in the CT group completed the exercise program once a day and three days a week during the 10-week period under the physicians' supervision. The exercises consisted of standing on one leg, tandem walking (heel-to-toe), balance board exercises, Romberg exercise, backward walking, and side-to-side stepping exercises. The total duration of these exercises was 20-30 minutes. Furthermore this group also received CKCE in addition to their own exercise program, which was applied in exactly the same way. The CKCE were performed in three sets of 10 repetitions with five seconds rest between each exercise. The exercises consisted of mini-squats, wall sits, and lunges. Receives: Other: Balance and proprioception exercises |
| Control group | Active comparator | Isometric home exercises, which can be considered the most basic and feasible strengthening program, were selected to compare the effects they had when added to the intervention groups and administered alone. All patients in the study performed isometric exercises for the quadriceps and hamstrings at home once a day, three days a week for 10 weeks. The exercises were performed as 10 repetitive cycles of six-second contractions and two-second rest periods. All patients were given a daily exercise chart to mark the home program, and adherence to the exercises was monitored weekly by telephone call. Receives: Other: Home exercises program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance
The postural stability test, was performed with the following parameters: Duration: 20 seconds, Stability level: 8, and Stance: two legs. The value of overall stability index (OSI) is obtained by calculating the standard deviations of the degrees of inclination with respect to the zero point (locked position). Higher values indicate poorer equilibrium.
Measured: Baseline
Dynamic balance
The postural stability test, was performed with the following parameters: Duration: 20 seconds, Stability level: 8, and Stance: two legs. The value of overall stability index (OSI) is obtained by calculating the standard deviations of the degrees of inclination with respect to the zero point (locked position). Higher values indicate poorer equilibrium.
Measured: 10th week
Dynamic balance
The modified Clinical Test of Sensory Interaction and Balance (mCTSIB).The entire test is performed with the platform in the locked position. The test consists of 4 conditions: Condition 1: eyes open firm surface, Condition 2: eyes closed firm surface, Condition 3: eyes open dynamic (foam) surface, and Condition 4: eyes closed dynamic (foam) surface. The firm and dynamic surface tests assess static and dynamic balance, respectively. The conditions under which visual data are blocked are designed to detect even minor balance disturbances caused by the sensorimotor system. The sway index obtained as a result of the test represents the average position of the patient's center of mass relative to the center of the platform. Higher values indicate poorer balance. mCTSIB Condition-3, and mCTSIB Condition-4 dynamic balance assessment tests were used to assess dynamic balance.
Measured: Baseline
Dynamic balance
The modified Clinical Test of Sensory Interaction and Balance (mCTSIB).The entire test is performed with the platform in the locked position. The test consists of 4 conditions: Condition 1: eyes open firm surface, Condition 2: eyes closed firm surface, Condition 3: eyes open dynamic (foam) surface, and Condition 4: eyes closed dynamic (foam) surface. The firm and dynamic surface tests assess static and dynamic balance, respectively. The conditions under which visual data are blocked are designed to detect even minor balance disturbances caused by the sensorimotor system. The sway index obtained as a result of the test represents the average position of the patient's center of mass relative to the center of the platform. Higher values indicate poorer balance. mCTSIB Condition-3, and mCTSIB Condition-4 dynamic balance assessment tests were used to assess dynamic balance.
Measured: 10th week
Secondary outcomes (8)
Pain score
Patients' pain scores at night, at rest, and during movement were measured using visual analogue scale (VAS) (0-10 cm; 0 indicates no pain and 10 indicates severe pain).
Measured: Baseline
Pain score
Patients' pain scores at night, at rest, and during movement were measured using visual analogue scale (VAS) (0-10 cm; 0 indicates no pain and 10 indicates severe pain).
Measured: 10th week
Physical function
Physical function was assessed using the 30-second chair stand test (30CST) , which is recommended by the Osteoarthritis Research Society International (OARSI). Patients sit in a chair with the knees bent slightly more than 90 degrees and the feet on the floor at an angle behind the knees. While arms are crossed in front of the chest, patients stand up with lower limbs fully extended and sit back down with full contact to the chair. The movement of standing up and sitting down is counted as one cycle. The number of cycles during the 30-second period is recorded. Increasing values indicate good performance.
Measured: Baseline
Physical function
Physical function was assessed using the 30-second chair stand test (30CST) , which is recommended by the Osteoarthritis Research Society International (OARSI). Patients sit in a chair with the knees bent slightly more than 90 degrees and the feet on the floor at an angle behind the knees. While arms are crossed in front of the chest, patients stand up with lower limbs fully extended and sit back down with full contact to the chair. The movement of standing up and sitting down is counted as one cycle. The number of cycles during the 30-second period is recorded. Increasing values indicate good performance
Measured: 10th week
Physical function
Physical function was assessed using the 40-meter fast-paced walk test (40-m-FPWT) , which is recommended by the Osteoarthritis Research Society International (OARSI). Two cones are used to mark the start and stop lines of a 10-meter walkway. Patients are asked to walk as fast as they can along the walkway without running, and then turn around four times, and the total time recorded. Decreasing values indicate good performance
Measured: Baseline
Physical function
Physical function was assessed using the 40-meter fast-paced walk test (40-m-FPWT) , which is recommended by the Osteoarthritis Research Society International (OARSI). Two cones are used to mark the start and stop lines of a 10-meter walkway. Patients are asked to walk as fast as they can along the walkway without running, and then turn around four times, and the total time recorded. Decreasing values indicate good performance
Measured: 10th week
Quality of life (QoL)
QoL of patients was assessed using the QoL subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS consists of five subscales assessing pain, other symptoms, activities of daily living, sports and leisure time, and QoL. Each question is scored on a five-point scale ranging from 0 to 4. Scores close to 100 represent good outcomes, while scores close to 0 represent poor outcomes
Measured: Baseline
Quality of life (QoL)
QoL of patients was assessed using the QoL subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS consists of five subscales assessing pain, other symptoms, activities of daily living, sports and leisure time, and QoL. Each question is scored on a five-point scale ranging from 0 to 4. Scores close to 100 represent good outcomes, while scores close to 0 represent poor outcomes
Measured: 10th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study startMay 2014
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This was a single-center randomized trial with 3 parallel arms
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BUGRA INCE, MD, Principal investigator, Bozyaka Training and Research HospitalALTINAY GOKSEL KARATEPE, MD, Study director, University of Health Sciences Izmır Faculty, Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287802
- Sponsor's protocol ID
- BI1422
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: upon request
Publications
Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
PubMed 17216685Anwer S, Alghadir A, Brismee JM. Effect of Home Exercise Program in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. J Geriatr Phys Ther. 2016 Jan-Mar;39(1):38-48. doi: 10.1519/JPT.0000000000000045.
PubMed 25695471Niino N, Tsuzuku S, Ando F, Shimokata H. Frequencies and circumstances of falls in the National Institute for Longevity Sciences, Longitudinal Study of Aging (NILS-LSA). J Epidemiol. 2000 Apr;10(1 Suppl):S90-4. doi: 10.2188/jea.10.1sup_90.
PubMed 10835834Khan SJ, Khan SS, Usman J, Mokhtar AH, Abu Osman NA. Effects of different foot progression angles and platform settings on postural stability and fall risk in healthy and medial knee osteoarthritic adults. Proc Inst Mech Eng H. 2018 Feb;232(2):163-171. doi: 10.1177/0954411917750409. Epub 2017 Dec 28.
PubMed 29283019Jan MH, Lin CH, Lin YF, Lin JJ, Lin DH. Effects of weight-bearing versus nonweight-bearing exercise on function, walking speed, and position sense in participants with knee osteoarthritis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Jun;90(6):897-904. doi: 10.1016/j.apmr.2008.11.018.
PubMed 19480863
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Balance and Proprioception Exercises in Patients With Knee Osteoarthritis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05287802
- Acronym / sponsor ID
- BI1422
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 18 Mar 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.
This study aime to investigate the effects of balance and proprioception exercises using two different methods (classical balance training and Balance System™ SD) in addition to strengthening exercises on dynamic balance, pain, functional status and quality of life in patients with knee osteoarthritis (OA).
Detailed description
It is known that knee OA leads to a decrease in proprioception and balance disturbances. Falls due to balance disorders often occur during dynamic activities such as walking and stair climbing. Therefore, correction of balance disorders is of great importance to prevent falls and associated fractures in the elderly population, in which knee OA is common. In addition, loss of proprioception in the knee joint, muscle weakness, and balance disorders are also known to contribute to the development of knee OA itself. Therefore, treatment of balance disorders may also slow the progression of the disease. This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This is a single-center randomized trial with 3 parallel arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This study was planned to compare the effects of isometric strengthening exercises plus balance and proprioception exercises performed by two different methods with isometric strengthening exercises alone. This was a single-center randomized trial with 3 parallel arms
| Arm | Type | Receives |
|---|---|---|
| Biodex Training (BT) group | Active comparator | Other: Balance and proprioception exercisesBiodex Balance System features a platform that can move simultaneously in the anteroposterior (AP) or medio-lateral (ML) direction in 12 different levels of stability within a 20-degree range of inclination, as well as a locked position for static environments. For this platform, 1 represents the least stable level and 12 represents the most stable level. Interactive, game-like training modes are provided with the on-screen grid and score-keeping functions. Patients in the BT group performed exercises with the Balance SystemTM SD once a day, three days a week for 10 weeks under the physicians' supervision. Furthermore this group received closed kinetic chain exercises (CKCE) in addition to their own exercise program, which was applied in exactly the same way. The CKCE were performed in three sets of 10 repetitions with five seconds rest between each exercise. The exercises consisted of mini-squats, wall sits, and lunges. |
| Classical balance training group (CT group) | Active comparator | Other: Balance and proprioception exercisesPatients in the CT group completed the exercise program once a day and three days a week during the 10-week period under the physicians' supervision. The exercises consisted of standing on one leg, tandem walking (heel-to-toe), balance board exercises, Romberg exercise, backward walking, and side-to-side stepping exercises. The total duration of these exercises was 20-30 minutes. Furthermore this group also received CKCE in addition to their own exercise program, which was applied in exactly the same way. The CKCE were performed in three sets of 10 repetitions with five seconds rest between each exercise. The exercises consisted of mini-squats, wall sits, and lunges. |
| Control group | Active comparator | Other: Home exercises programIsometric home exercises, which can be considered the most basic and feasible strengthening program, were selected to compare the effects they had when added to the intervention groups and administered alone. All patients in the study performed isometric exercises for the quadriceps and hamstrings at home once a day, three days a week for 10 weeks. The exercises were performed as 10 repetitive cycles of six-second contractions and two-second rest periods. All patients were given a daily exercise chart to mark the home program, and adherence to the exercises was monitored weekly by telephone call. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were included if they had a knee OA diagnosis according to the American College of Rheumatology (ACR) diagnostic criteria, had suffered from knee pain for at least six months, had radiologically verified bilateral knee OA of grade II or III according to the Kellgren-Lawrence classification and had not previously participated in a regular exercise program.
Key exclusion criteria (1 listed)
- Patients who had undergone knee surgery, who had received hyaluronic acid or corticosteroid injections into the knee within six months, and patients with conditions that might affect balance were excluded from the study.
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 |
|---|---|---|
| Balance and proprioception exercisesBalance and proprioception exercises using two different methods (classical balance training and Biodex) in addition to strengthening exercises | Other | Biodex Training (BT) group, Classical balance training group (CT group) |
| Home exercises programIsometric exercises for the quadriceps and hamstrings at home | Other | Control group |
Primary outcome
Dynamic balance
Time frame: Baseline
The postural stability test, was performed with the following parameters: Duration: 20 seconds, Stability level: 8, and Stance: two legs. The value of overall stability index (OSI) is obtained by calculating the standard deviations of the degrees of inclination with respect to the zero point (locked position). Higher values indicate poorer equilibrium.
Dynamic balance
Time frame: 10th week
The postural stability test, was performed with the following parameters: Duration: 20 seconds, Stability level: 8, and Stance: two legs. The value of overall stability index (OSI) is obtained by calculating the standard deviations of the degrees of inclination with respect to the zero point (locked position). Higher values indicate poorer equilibrium.
Dynamic balance
Time frame: Baseline
The modified Clinical Test of Sensory Interaction and Balance (mCTSIB).The entire test is performed with the platform in the locked position. The test consists of 4 conditions: Condition 1: eyes open firm surface, Condition 2: eyes closed firm surface, Condition 3: eyes open dynamic (foam) surface, and Condition 4: eyes closed dynamic (foam) surface. The firm and dynamic surface tests assess static and dynamic balance, respectively. The conditions under which visual data are blocked are designed to detect even minor balance disturbances caused by the sensorimotor system. The sway index obtained as a result of the test represents the average position of the patient's center of mass relative to the center of the platform. Higher values indicate poorer balance. mCTSIB Condition-3, and mCTSIB Condition-4 dynamic balance assessment tests were used to assess dynamic balance.
Dynamic balance
Time frame: 10th week
The modified Clinical Test of Sensory Interaction and Balance (mCTSIB).The entire test is performed with the platform in the locked position. The test consists of 4 conditions: Condition 1: eyes open firm surface, Condition 2: eyes closed firm surface, Condition 3: eyes open dynamic (foam) surface, and Condition 4: eyes closed dynamic (foam) surface. The firm and dynamic surface tests assess static and dynamic balance, respectively. The conditions under which visual data are blocked are designed to detect even minor balance disturbances caused by the sensorimotor system. The sway index obtained as a result of the test represents the average position of the patient's center of mass relative to the center of the platform. Higher values indicate poorer balance. mCTSIB Condition-3, and mCTSIB Condition-4 dynamic balance assessment tests were used to assess dynamic balance.
8 secondary outcomes
Pain score
Time frame: Baseline
Pain score
Time frame: 10th week
Physical function
Time frame: Baseline
Physical function
Time frame: 10th week
Physical function
Time frame: Baseline
Physical function
Time frame: 10th week
Quality of life (QoL)
Time frame: Baseline
Quality of life (QoL)
Time frame: 10th 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 18 Mar 2022.
- Background: PubMed 17216685Jordan JM, Helmick CG, Renner JB, Luta G, Dragomir AD, Woodard J, Fang F, Schwartz TA, Abbate LM, Callahan LF, Kalsbeek WD, Hochberg MC. Prevalence of knee symptoms and radiographic and symptomatic knee osteoarthritis in African Americans and Caucasians: the Johnston County Osteoarthritis Project. J Rheumatol. 2007 Jan;34(1):172-80.
- Background: PubMed 25695471Anwer S, Alghadir A, Brismee JM. Effect of Home Exercise Program in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. J Geriatr Phys Ther. 2016 Jan-Mar;39(1):38-48. doi: 10.1519/JPT.0000000000000045.
- Background: PubMed 10835834Niino N, Tsuzuku S, Ando F, Shimokata H. Frequencies and circumstances of falls in the National Institute for Longevity Sciences, Longitudinal Study of Aging (NILS-LSA). J Epidemiol. 2000 Apr;10(1 Suppl):S90-4. doi: 10.2188/jea.10.1sup_90.
- Background: PubMed 29283019Khan SJ, Khan SS, Usman J, Mokhtar AH, Abu Osman NA. Effects of different foot progression angles and platform settings on postural stability and fall risk in healthy and medial knee osteoarthritic adults. Proc Inst Mech Eng H. 2018 Feb;232(2):163-171. doi: 10.1177/0954411917750409. Epub 2017 Dec 28.
- Background: PubMed 19480863Jan MH, Lin CH, Lin YF, Lin JJ, Lin DH. Effects of weight-bearing versus nonweight-bearing exercise on function, walking speed, and position sense in participants with knee osteoarthritis: a randomized controlled trial. Arch Phys Med Rehabil. 2009 Jun;90(6):897-904. doi: 10.1016/j.apmr.2008.11.018.
- Individual participant dataSharing planned: No. upon request
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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.
BUGRA INCE, MD principal investigator
Bozyaka Training and Research Hospital
ALTINAY GOKSEL KARATEPE, MD study director
University of Health Sciences Izmır Faculty, Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance and proprioception exercises and Home exercises program in people with Knee Osteoarthritis and Balance; Distorted, run by Bozyaka Training and Research Hospital 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 1 inclusion and 1 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 18 Mar 2022. 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?
Dynamic balance (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287802, which also lists 5 linked publications.
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 18 Mar 2022.