Joint Position Sense, Plantar Sensation, Balance and Dual Task Performance in Individuals With Type 2 Diabetes

January 22, 2021 updated by: Ertuğrul Demirdel, Ankara Yildirim Beyazıt University

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.

Study Overview

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

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ankara, Turkey
        • Ankara Yıldırım Beyazıt University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Type 2 diabetic individuals between the ages of 30-65

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 25, 2019

Primary Completion (ACTUAL)

August 25, 2019

Study Completion (ACTUAL)

March 25, 2020

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 20, 2019

First Posted (ACTUAL)

March 22, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 22, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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