- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03885869
Joint Position Sense, Plantar Sensation, Balance and Dual Task Performance in Individuals With Type 2 Diabetes
Investigation of Relationships Between Joint Position Sense, Plantar Sensation, Balance and Dual Task Performance in Individuals With Type 2 Diabetes
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ankara, Turkey
- Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Type 2 Diabetics
Type 2 diabetic individuals aged 30-65 years
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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.
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.
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.
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.
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
A form, which is prepared by us, including demographic information and physical characteristics of the individuals.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 month
|
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.
|
1month
|
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. |
1month
|
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.
|
1month
|
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. |
1month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-83
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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