Relationships Between Joint Position Sense, Plantar Sensation, Balance and Dual Task Performance in Individuals With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT03885869 |
Recruitment Status :
Not yet recruiting
First Posted : March 22, 2019
Last Update Posted : March 25, 2019
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Condition or disease | Intervention/treatment |
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Type 2 Diabetes Mellitus Balance | 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 |
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 Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Other |
Time Perspective: | Cross-Sectional |
Official Title: | Investigation of Relationships Between Joint Position Sense, Plantar Sensation, Balance and Dual Task Performance in Individuals With Type 2 Diabetes |
Estimated Study Start Date : | March 25, 2019 |
Estimated Primary Completion Date : | August 25, 2019 |
Estimated Study Completion Date : | March 25, 2020 |

Group/Cohort | Intervention/treatment |
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Type 2 Diabetics
Type 2 diabetic individuals aged 30-65 years
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Other: Ankle Joint Position Sensation Evaluation
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. Other: Knee Joint Position Sensation Evaluation 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. Other: 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. Other: The Evaluation of Balance 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. Other: 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 Other: General Evaluation Form A form, which is prepared by us, including demographic information and physical characteristics of the individuals. |
- 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.

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Ages Eligible for Study: | 30 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- to accept to participate in the study voluntarily,
- to being diagnosed with type 2 diabetes,
- to being 30-65 age range.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885869
Contact: Nazire Nur Yıldız, PT | +905444184376 | nnur_yildiz_58@hotmail.com | |
Contact: Ertuğrul Demirdel, Asst. Prof. | +905378223551 | ertudemirdel@yahoo.com |
Turkey | |
Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation | |
Ankara, Turkey |
Principal Investigator: | Nazire Nur Yıldız, PT | AYBU Institute of Health Sciences Department of Physiotherapy and Rehabilitation Master Program/Master Degree Student |
Responsible Party: | Ankara Yildirim Beyazıt University |
ClinicalTrials.gov Identifier: | NCT03885869 |
Other Study ID Numbers: |
2019-83 |
First Posted: | March 22, 2019 Key Record Dates |
Last Update Posted: | March 25, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Type 2 Diabetes Mellitus Joint Position Sense Plantar Sensation Balance Dual Task Performance |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |