Type 2 Diabetes MellitusNCT03885869
Joint Position Sense, Plantar Sensation, Balance and Dual Task Performance in Individuals With Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus and Balance, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
Diabetes is a chronic disease characterized by hyperglycemia, which occurs when insulin is inadequate or the body's produced insulin cannot be used effectively, but according to the World Health Organization 2016 Global Report on Diabetes, it is an important public health problem that is one of the four priority… Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Balance
- What is being tested?
- Ankle Joint Position Sensation Evaluation, Knee Joint Position Sensation Evaluation and The Evaluation of Plantar Sensation
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2019to 25 Mar 2020
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetic individuals between the ages of 30-65
Who may be able to join
- to accept to participate in the study voluntarily,
- to being diagnosed with type 2 diabetes,
- to being 30-65 age range.
Who cannot join
- refuse to participate in the study,
- Not cooperating,
- Being orthopedic, neurological and any other systemic disease,
- Being pregnant,
- Loss of vision,
- Loss of hearing,
- To be a standing diabetic ulcer,
- A Mini Mental Test score of 23 or less.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
Ankara
About this study
Official title: Investigation of Relationships Between Joint Position Sense, Plantar Sensation, Balance and Dual Task Performance in Individuals With Type 2 Diabetes
Diabetes is a chronic disease characterized by hyperglycemia, which occurs when insulin is inadequate or the body's produced insulin cannot be used effectively, but according to the World Health Organization 2016 Global Report on Diabetes, it is an important public health problem that is one of the four priority non-infectious diseases. In addition to high mortality rates caused by diabetes-related complications, it is known that it can cause low quality of life and many additional problems in individuals. These complications and damage, which may be caused by diabetes, may result in reduced blood flow combined with neuropathy; As a result, foot ulcers, infections and consequently the need for amputation may increase. In addition to the additional complications caused by diabetic neuropathy, protective plantar sensory loss and decreased joint position have been reported in the literature. In particular, investigators did not find any comprehensive studies examining the relationship between these sensory changes and the dual task performance in diabetic subjects. In this study, investigators aimed to investigate the relationship between joint position sense, plantar sensation, balance and dual task performance in individuals with type 2 diabetes and to contribute to the literature with evidence-based, objective results.
Read the detailed description
The aim of this study is to investigate that the relationships between joint position sensation, plantar sensation, balance and dual task performance in type 2 diabetic patients.
First of all, a general evaluation form including demographic information and physical characteristics of the individuals who voluntarily agree to participate in the study and approve the informed consent form, will be filled. Then, with the first findings to be obtained, determination of sample size was planned. Bilateral ankle joint position sensation with goniometer, bilateral knee joint position sensation with an analog inclinometer (BASELINE® Bubble inclinometer-USA), plantar sensation with Semmens-Wenstein monofilaments, equilibrium with Prokin Isokinetic Balance System, dual task performance will be evaluated with adding motor and cognitive secondary tasks to the Time Up and Go Test and single leg balance tests.
- Conditions
- Type 2 Diabetes Mellitus, Balance
- Being tested
- Ankle Joint Position Sensation Evaluation, Knee Joint Position Sensation Evaluation, The Evaluation of Plantar Sensation, The Evaluation of Balance, Evaluation of Dual Task Performance
- Keywords
- Type 2 Diabetes Mellitus, Joint Position Sense, Plantar Sensation, Balance, Dual Task Performance
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Joint Position Sensation EvaluationOther
In this test, individuals are placed in the supine position with their eyes closed for prevent visual cues; measurements are performed with the plex of the goniometer, 1.5 cm below the lateral malleol, the fixed arm parallel to the long axis of the fibula and the movable arm parallel to the long axis of the 5th metatarsal. Desired target angles were defined as 10 ° dorsi flexion, 10 ° plantar flexion and 20 ° plantar flexion. Individuals are instructed to focus on the position of the ankle joints in space for 5 s by bringing the feet in neutral position to the target position by the researcher. This procedure is repeated 3 times and the patient is expected to learn this position. The target angle is then asked to repeat in the testing phase. The measurement is repeated 3 times for each target angle. As a result criterion; By recording the absolute value of the deviation amounts from the target angles; The averages of the deviations during the 3 repetitions are averaged.
Knee Joint Position Sensation EvaluationOther
Bilateral knee joint position sensation will be evaluated in the literature with an analogue inclinometer(BASELINE®),which is a valid and reliable method for measuring joint position sensations.Measurements were planned to made in the sitting position,with the eyes of the individual closed and the joint to be evaluated bare,without any socks or shoes worn,fixing the inclinometer with a strap to the lower leg perpendicular to the knee flexion axis.In this measurement,the knees of the participants are passively shifted from the initial (90°flexion)position to the 30°flexion position,at this point 5 sec is waited and after they are told to keep this angle in mind,the starting position is returned.This procedure is repeated 3 times and the patient is expected to learn this position.After the individuals are rested for 5 s,they are asked to actively perform the target angle again.The same procedure was planned to be repeated 3 times for each angle at 45° and 60° knee flexion target angles.
The Evaluation of Plantar SensationOther
In the plantar sensory evaluation of the participants, Semmes-Wenstein Monofilament, which is frequently used in the literature and to be a reliable method in the diagnosis of neuropathy, was aimed to be tested by touching 7 regions on the foot base .
In this evaluation, the individual is in the supine position, the physiotherapist is at the foot end of the patient; monofilament should be applied 90⁰ to the surface.
The filament thickness which is the first feeling of the individual is recorded by being asked whether the individual is feeling. The 3 most commonly used monofilaments for patients with diabetic neuropathy are 4.17, 5.07 and 6.10 monofilaments. The highest monofilament value is the hardest and most difficult bending monofilament.
The Evaluation of BalanceOther
In order to evaluate the static and dynamic balances of the participants, determination of open and closed postural oscillations and stability limits were planned with Prokin branded isokinetic balance system.
Evaluation of Dual Task PerformanceOther
In order to evaluate double task performances, it is planned to evaluate 1 dynamic and 1 static 2 different performances, including Time Up and Go Test (TUG) and single leg standing time. For each performance; the single task, the motor second task and cognitive seconder tasks separately, and again for each application to be performed in such a way that two trials, the average time was planned to record. Motor and cognitive tasks for each test are planned as described below.
Motor Task (TUG): Carrying cup full of water on tray. Cognitive Task (TUG): Counting the days of the week backwards from the current day Motor Task (Single Leg Standing Time): Hand-Over ball transfer Cognitive Task (Single Leg Standing Time): Counting backward month names from the current month
General Evaluation FormOther
A form, which is prepared by us, including demographic information and physical characteristics of the individuals.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetics | Type 2 diabetic individuals aged 30-65 years Receives: Other: Ankle Joint Position Sensation Evaluation; Other: Knee Joint Position Sensation Evaluation; Other: The Evaluation of Plantar Sensation; Other: The Evaluation of Balance; Other: Evaluation of Dual Task Performance; Other: General Evaluation Form |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Evaluation of Ankle Joint Position Sensation
In this test, individuals are placed in the supine position with their eyes closed for prevent visual cues; measurements are performed with the plex of the goniometer, 1.5 cm below the lateral malleol, the fixed arm parallel to the long axis of the fibula and the movable arm parallel to the long axis of the 5th metatarsal. Desired target angles were defined as 10 ° dorsi flexion, 10 ° plantar flexion and 20 ° plantar flexion. Individuals are instructed to focus on the position of the ankle joints in space for 5 s by bringing the feet in neutral position to the target position by the researcher. This procedure is repeated 3 times and the patient is expected to learn this position. The target angle is then asked to repeat in the testing phase. The measurement is repeated 3 times for each target angle. As a result criterion; By recording the absolute value of the deviation amounts from the target angles; The averages of the deviations during the 3 repetitions are averaged.
Measured: 1 month
The Evaluation of Knee Joint Position Sensation
Bilateral knee joint position sensation will be evaluated in the literature with an analogue inclinometer(BASELINE®),which is a valid and reliable method for measuring joint position sensations.Measurements were planned to made in the sitting position,with the eyes of the individual closed and the joint to be evaluated bare,without any socks or shoes worn,fixing the inclinometer with a strap to the lower leg perpendicular to the knee flexion axis.In this measurement,the knees of the participants are passively shifted from the initial(90°flexion)position to the 30°flexion position,at this point 5 sec is waited and after they are told to keep this angle in mind,the starting position is returned.This procedure is repeated 3 times and the patient is expected to learn this position.After the individuals are rested for 5 s,they are asked to actively perform the target angle again.The same procedure was planned to be repeated 3times for each angle at 45° and 60°knee flexion target angles.
Measured: 1month
The Evaluation of Plantar Sensation
In the plantar sensory evaluation of the participants, Semmes-Wenstein Monofilament, which is frequently used in the literature and to be a reliable method in the diagnosis of neuropathy, was aimed to be tested by touching 7 regions on the foot base .
In this evaluation, the individual is in the supine position, the physiotherapist is at the foot end of the patient; monofilament should be applied 90⁰ to the surface.
The filament thickness which is the first feeling of the individual is recorded by being asked whether the individual is feeling. The 3 most commonly used monofilaments for patients with diabetic neuropathy are 4.17, 5.07 and 6.10 monofilaments. The highest monofilament value is the hardest and most difficult bending monofilament.
Measured: 1month
Evaluation of Balance Performance
In order to evaluate the static and dynamic balances of the participants, determination of open and closed postural oscillations and stability limits were planned with Prokin branded isokinetic balance system.
Measured: 1month
The Evaluation of Dual Task Performance
In order to evaluate double task performances, it is planned to evaluate 1 dynamic and 1 static 2 different performances, including Time Up and Go Test (TUG) and single leg standing time. For each performance; the single task, the motor second task and cognitive seconder tasks separately, and again for each application to be performed in such a way that two trials, the average time was planned to record. Motor and cognitive tasks for each test are planned as described below.
Motor Task (TUG): Carrying cup full of water on tray. Cognitive Task (TUG): Counting the days of the week backwards from the current day Motor Task (Single Leg Standing Time): Hand-Over ball transfer Cognitive Task (Single Leg Standing Time): Counting backward month names from the current month.
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start25 Mar 2019
- Primary completion25 Aug 2019
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ertuğrul Demirdel, Ankara Yildirim Beyazıt University
- Investigators
- Nazire Nur Yıldız, PT, Principal investigator, AYBU Institute of Health Sciences Department of Physiotherapy and Rehabilitation Master Program/Master Degree Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885869
- Sponsor's protocol ID
- 2019-83
- Status last verified
- Jan 2021
- First submitted
- 20 Mar 2019
- Last updated
- 26 Jan 2021
- 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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Relationships Between Joint Position Sense, Plantar Sensation, Balance and Dual Task Performance in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03885869
- Acronym / sponsor ID
- 2019-83
- Conditions
- Type 2 Diabetes Mellitus, Balance
- Keywords
- Type 2 Diabetes Mellitus, Joint Position Sense, Plantar Sensation, Balance, Dual Task Performance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 22 Mar 2019 (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.
Diabetes is a chronic disease characterized by hyperglycemia, which occurs when insulin is inadequate or the body's produced insulin cannot be used effectively, but according to the World Health Organization 2016 Global Report on Diabetes, it is an important public health problem that is one of the four priority non-infectious diseases. In addition to high mortality rates caused by diabetes-related complications, it is known that it can cause low quality of life and many additional problems in individuals. These complications and damage, which may be caused by diabetes, may result in reduced blood flow combined with neuropathy; As a result, foot ulcers, infections and consequently the need for amputation may increase. In addition to the additional complications caused by diabetic neuropathy, protective plantar sensory loss and decreased joint position have been reported in the literature. In particular, investigators did not find any comprehensive studies examining the relationship between these sensory changes and the dual task performance in diabetic subjects. In this study, investigators aimed to investigate the relationship between joint position sense, plantar sensation, balance and dual task performance in individuals with type 2 diabetes and to contribute to the literature with evidence-based, objective results.
Detailed description
The aim of this study is to investigate that the relationships between joint position sensation, plantar sensation, balance and dual task performance in type 2 diabetic patients.
First of all, a general evaluation form including demographic information and physical characteristics of the individuals who voluntarily agree to participate in the study and approve the informed consent form, will be filled. Then, with the first findings to be obtained, determination of sample size was planned. Bilateral ankle joint position sensation with goniometer, bilateral knee joint position sensation with an analog inclinometer (BASELINE® Bubble inclinometer-USA), plantar sensation with Semmens-Wenstein monofilaments, equilibrium with Prokin Isokinetic Balance System, dual task performance will be evaluated with adding motor and cognitive secondary tasks to the Time Up and Go Test and single leg balance tests.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetics | – | Other: Ankle Joint Position Sensation Evaluation, Other: Knee Joint Position Sensation Evaluation, Other: The Evaluation of Plantar Sensation, Other: The Evaluation of Balance, Other: Evaluation of Dual Task Performance, Other: General Evaluation FormType 2 diabetic individuals aged 30-65 years |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetic individuals between the ages of 30-65
Key inclusion criteria (3 listed)
- to accept to participate in the study voluntarily,
- to being diagnosed with type 2 diabetes,
- to being 30-65 age range.
Key exclusion criteria (8 listed)
- refuse to participate in the study,
- Not cooperating,
- Being orthopedic, neurological and any other systemic disease,
- Being pregnant,
- Loss of vision,
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 |
|---|---|---|
| Ankle Joint Position Sensation EvaluationIn this test, individuals are placed in the supine position with their eyes closed for prevent visual cues; measurements are performed with the plex of the goniometer, 1.5 cm below the lateral malleol, the fixed arm parallel to the long axis of the fibula and the movable arm parallel to the long axis of the 5th metatarsal. Desired target angles were defined as 10 ° dorsi flexion, 10 ° plantar flexion and 20 ° plantar flexion. Individuals are instructed to focus on the position of the ankle joints in space for 5 s by bringing the feet in neutral position to the target position by the researcher. This procedure is repeated 3 times and the patient is expected to learn this position. The target angle is then asked to repeat in the testing phase. The measurement is repeated 3 times for each target angle. As a result criterion; By recording the absolute value of the deviation amounts from the target angles; The averages of the deviations during the 3 repetitions are averaged. | Other | Type 2 Diabetics |
| Knee Joint Position Sensation EvaluationBilateral knee joint position sensation will be evaluated in the literature with an analogue inclinometer(BASELINE®),which is a valid and reliable method for measuring joint position sensations.Measurements were planned to made in the sitting position,with the eyes of the individual closed and the joint to be evaluated bare,without any socks or shoes worn,fixing the inclinometer with a strap to the lower leg perpendicular to the knee flexion axis.In this measurement,the knees of the participants are passively shifted from the initial (90°flexion)position to the 30°flexion position,at this point 5 sec is waited and after they are told to keep this angle in mind,the starting position is returned.This procedure is repeated 3 times and the patient is expected to learn this position.After the individuals are rested for 5 s,they are asked to actively perform the target angle again.The same procedure was planned to be repeated 3 times for each angle at 45° and 60° knee flexion target angles. | Other | Type 2 Diabetics |
| The Evaluation of Plantar SensationIn the plantar sensory evaluation of the participants, Semmes-Wenstein Monofilament, which is frequently used in the literature and to be a reliable method in the diagnosis of neuropathy, was aimed to be tested by touching 7 regions on the foot base . In this evaluation, the individual is in the supine position, the physiotherapist is at the foot end of the patient; monofilament should be applied 90⁰ to the surface. The filament thickness which is the first feeling of the individual is recorded by being asked whether the individual is feeling. The 3 most commonly used monofilaments for patients with diabetic neuropathy are 4.17, 5.07 and 6.10 monofilaments. The highest monofilament value is the hardest and most difficult bending monofilament. | Other | Type 2 Diabetics |
| The Evaluation of BalanceIn order to evaluate the static and dynamic balances of the participants, determination of open and closed postural oscillations and stability limits were planned with Prokin branded isokinetic balance system. | Other | Type 2 Diabetics |
| Evaluation of Dual Task PerformanceIn order to evaluate double task performances, it is planned to evaluate 1 dynamic and 1 static 2 different performances, including Time Up and Go Test (TUG) and single leg standing time. For each performance; the single task, the motor second task and cognitive seconder tasks separately, and again for each application to be performed in such a way that two trials, the average time was planned to record. Motor and cognitive tasks for each test are planned as described below. Motor Task (TUG): Carrying cup full of water on tray. Cognitive Task (TUG): Counting the days of the week backwards from the current day Motor Task (Single Leg Standing Time): Hand-Over ball transfer Cognitive Task (Single Leg Standing Time): Counting backward month names from the current month | Other | Type 2 Diabetics |
| General Evaluation FormA form, which is prepared by us, including demographic information and physical characteristics of the individuals. | Other | Type 2 Diabetics |
Primary outcome
The Evaluation of Ankle Joint Position Sensation
Time frame: 1 month
In this test, individuals are placed in the supine position with their eyes closed for prevent visual cues; measurements are performed with the plex of the goniometer, 1.5 cm below the lateral malleol, the fixed arm parallel to the long axis of the fibula and the movable arm parallel to the long axis of the 5th metatarsal. Desired target angles were defined as 10 ° dorsi flexion, 10 ° plantar flexion and 20 ° plantar flexion. Individuals are instructed to focus on the position of the ankle joints in space for 5 s by bringing the feet in neutral position to the target position by the researcher. This procedure is repeated 3 times and the patient is expected to learn this position. The target angle is then asked to repeat in the testing phase. The measurement is repeated 3 times for each target angle. As a result criterion; By recording the absolute value of the deviation amounts from the target angles; The averages of the deviations during the 3 repetitions are averaged.
The Evaluation of Knee Joint Position Sensation
Time frame: 1month
Bilateral knee joint position sensation will be evaluated in the literature with an analogue inclinometer(BASELINE®),which is a valid and reliable method for measuring joint position sensations.Measurements were planned to made in the sitting position,with the eyes of the individual closed and the joint to be evaluated bare,without any socks or shoes worn,fixing the inclinometer with a strap to the lower leg perpendicular to the knee flexion axis.In this measurement,the knees of the participants are passively shifted from the initial(90°flexion)position to the 30°flexion position,at this point 5 sec is waited and after they are told to keep this angle in mind,the starting position is returned.This procedure is repeated 3 times and the patient is expected to learn this position.After the individuals are rested for 5 s,they are asked to actively perform the target angle again.The same procedure was planned to be repeated 3times for each angle at 45° and 60°knee flexion target angles.
The Evaluation of Plantar Sensation
Time frame: 1month
In the plantar sensory evaluation of the participants, Semmes-Wenstein Monofilament, which is frequently used in the literature and to be a reliable method in the diagnosis of neuropathy, was aimed to be tested by touching 7 regions on the foot base . In this evaluation, the individual is in the supine position, the physiotherapist is at the foot end of the patient; monofilament should be applied 90⁰ to the surface. The filament thickness which is the first feeling of the individual is recorded by being asked whether the individual is feeling. The 3 most commonly used monofilaments for patients with diabetic neuropathy are 4.17, 5.07 and 6.10 monofilaments. The highest monofilament value is the hardest and most difficult bending monofilament.
Evaluation of Balance Performance
Time frame: 1month
In order to evaluate the static and dynamic balances of the participants, determination of open and closed postural oscillations and stability limits were planned with Prokin branded isokinetic balance system.
The Evaluation of Dual Task Performance
Time frame: 1month
In order to evaluate double task performances, it is planned to evaluate 1 dynamic and 1 static 2 different performances, including Time Up and Go Test (TUG) and single leg standing time. For each performance; the single task, the motor second task and cognitive seconder tasks separately, and again for each application to be performed in such a way that two trials, the average time was planned to record. Motor and cognitive tasks for each test are planned as described below. Motor Task (TUG): Carrying cup full of water on tray. Cognitive Task (TUG): Counting the days of the week backwards from the current day Motor Task (Single Leg Standing Time): Hand-Over ball transfer Cognitive Task (Single Leg Standing Time): Counting backward month names from the current month.
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 26 Jan 2021.
- 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.
Nazire Nur Yıldız, PT principal investigator
AYBU Institute of Health Sciences Department of Physiotherapy and Rehabilitation Master Program/Master Degree Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Balance, run by Ankara Yildirim Beyazıt 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 8 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 26 Jan 2021. 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?
The Evaluation of Ankle Joint Position Sensation (time frame: 1 month). The study lists 5 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 26 Jan 2021.