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

NCT03885869 | Completed

• 1 other identifier: 2019-83
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Type 2 Diabetes Mellitus; Balance

Keywords

Type 2 Diabetes Mellitus; Joint Position Sense; Plantar Sensation; Balance; Dual Task Performance

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  1month

Study Arms (1)

Type 2 Diabetics

Type 2 diabetic individuals aged 30-65 years

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

Interventions

Ankle Joint Position Sensation Evaluation OTHER

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.

Type 2 Diabetics

Knee Joint Position Sensation Evaluation OTHER

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.

Type 2 Diabetics

The Evaluation of Plantar Sensation OTHER

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.

Type 2 Diabetics

The Evaluation of Balance OTHER

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.

Type 2 Diabetics

Evaluation of Dual Task Performance OTHER

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

Type 2 Diabetics

General Evaluation Form OTHER

A form, which is prepared by us, including demographic information and physical characteristics of the individuals.

Type 2 Diabetics

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 2 diabetic individuals between the ages of 30-65

You may qualify if:

• to accept to participate in the study voluntarily,
• to being diagnosed with type 2 diabetes,
• to being 30-65 age range.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nazire Nur Yıldız, PT

  AYBU Institute of Health Sciences Department of Physiotherapy and Rehabilitation Master Program/Master Degree Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 22, 2019
• Study Start: March 25, 2019
• Primary Completion: August 25, 2019
• Study Completion: March 25, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)