Peripheral Protective Sensation in Type 2 Diabetes Mellitus

Diabetic Foot Clinical Trial

Official title:

The Effect of Peripheral Protective Sensation on Peripheral Muscle Strength, Functional Capacity, Balance and Physical Activity Level in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05904262
• Other study ID #: IstanbulKentU-FTR-MU-01
• Status: Completed
• Start date: June 6, 2023
• Est. completion date: July 25, 2023

Study information

• Verified date: July 2023
• Source: Istanbul Kent University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of our study was to investigate the effect of sole sensation on peripheral muscle strength, functional capacity, balance and physical activity level in individuals with Type 2 Diabetes Mellitus.

Description:

Type II diabetes mellitus (DM) is a chronic disease characterised by insulin resistance, which is common all over the world, imposes an economic burden on the patient and his/her family because it requires continuous care and treatment, and may adversely affect the quality and duration of life of patients by leading to organ and function losses due to the complications it causes. Today, diabetes is an increasingly important health problem due to its incidence and the problems it causes. In DM, macrovascular and microvascular complications are observed with the disease. It may lead to development of foot deformities, biomechanical abnormalities and loss of protective sensation in the foot due to motor, sensory and autonomic neuropathy especially in the lower extremity. In the progressive process, loss of protective sensation may result in peripheral neuropathy. In the literature, loss of protective sensation is shown as the primary cause of peripheral neuropathy. In a study, it was found that light touch pressure, two-point discrimination and vibration senses on the soles of the feet of patients with diabetes mellitus decreased compared to healthy individuals. Diabetic foot is an important complication of diabetes which can be prevented with patient education and early treatment, although mortality, morbidity and treatment costs are quite high. This condition affects the individual's life in many aspects. When reseracher examine the literature, most of the studies on physical activity, functional capacity and quality of life in individuals with Type 2 DM with neuropathy examine the effect of neuropathy on these parameters. There is little literature examining the effect of protective sensory loss before the development of neuropathy. Researcher think that it is important to evaluate the sole sensation before the development of neuropathy in type 2 DM patients in order to determine the risk factors. Researcher also think that we will contribute to the literature by examining the relationship between the level of protective sensory loss and muscle strength, functional capacity, balance and physical activity level.

The study is planned to include 30 volunteer participants diagnosed with Type 2 Diabetes Mellitus. In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®). In addition, participants are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Being diagnosed with Type 2 Diabetes Mellitus for at least 1 year

• To be between the ages of 18-65

• HbA1c value between 6.5-11

• No cognitive/mental problems

• Being able to walk independently

• Being literate in Turkish

Exclusion Criteria:

• Lack of co-operation

• Patients with uncontrolled hypertension and uncontrolled arrhythmias

• Vertigo and various vestibular system disorders

• Those with severe neurological or severe respiratory diseases

• Patients who have undergone percutaneous transluminal coronary angiography or have a cardiac pacemaker

• Previous stroke, myocardial infarction

• Patients with major musculoskeletal problems

• Chronic renal failure

• Chronic liver disease

• Patients with hip or knee replacement surgery in the last 5 years

• Patients with an injury involving the lower extremity in the last 6 months

• Those who are pregnant

• Those with haemolytic or renal anaemia

• Those who cannot read and write Turkish

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Foot
• Diabetic Neuropathies

Intervention

Other:
• Foot Sole Sensation Evaluation
Type 2 Diabetes Mellitus. In this prospective study based on face-to-face interview method; body fat (%), skeletal muscle mass (%) (with Omron BF511 Body Composition Monitor), waist and hip circumference, lower extremity muscle strength (for quadriceps and biceps muscles) (with muscle hand held dynamometer), It is planned to measure upper extremity muscle strength (grip strength) (with hand grip dynamometer), functional capacity (with 6 Minute Walk Test), postural stability, stability limits and sensory integration of balance (with Biodex Balance System®). In addition, individuals are expected to answer the questions of the International Physical Activity Questionnaire-Short Form (IPAQ) to evaluate their physical activity levels.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif Universty	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul Kent University	Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Foot Sole Sensation Evaluation	Light touch pressure sensation will be assessed with the 10-g monofilament -Semmes Weinstein test. A 128 Hz diapause will be used to test the sense of vibration. Firstly, the diaposon will be applied to the patient's wrist (it can be on the elbow or clavicle), so that the patient will know what to experience beforehand. The diapozone is placed on the bone on the dorsal side of the distal phalanx of the first toe of the foot.For two-point discrimination sensation, two-point discrimination distance measurement with an esthesiometer (Baseline® , White Plains, NY, USA) will be used	20 minute
Secondary	Body mass index	Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.; Japan)" will be used to measure Body mass index (kg/m2) of the participants.	5 minute
Secondary	Body Fat	Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.; Japan)" will be used to measure Body fat (%) of the participants.	5 minute
Secondary	Skeletal muscle mass	Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.; Japan)" will be used to measure skeletal mass (%) of the participants.	5 minute
Secondary	Resting metabolism	Digital, portable and non-invasive "Omron BF511 Body Composition Monitor (Omron Healthcare Co.,Ltd.; Japan)" will be used to measure resting metabolism (kcal) of the participants.	5 minute
Secondary	Balance	Postural stability, stability limits and sensory integration of balance will be evaluated with Biodex Balance System®. Biodex Balance System® is an equipment used to evaluate postural stability, stability limits and fall risk, and validity and reliability studies have been performed	20 minute
Secondary	International Physical Activity Questionnaire-Short Form (IPAQ)	The questionnaire includes questions about physical activity performed for at least 10 minutes in the last 7 days. In the questionnaire, it is determined how many days in the last week and how long each day was spent in heavy physical activity (VPA), moderate physical activity (MPA) and walking (W). In the last question, the time spent daily without moving is questioned.	3 minute
Secondary	Muscle strength	The muscle strength of M. Biceps Brachii and M. Quadriceps Femoris will be performed using an electronic hand dynamometer (Commander Muscle Tester; JTECH Medical, USA). The grip force will be performed from the dominant hand using a Jamar brand dynamometer from hydraulic measuring instruments. Data obtained will be recorded in kilograms/force (kg/N)	15 minute