Ignite Creation Date:
2024-05-06 @ 7:08 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904262
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-05-24
Brief Title:
Peripheral Protective Sensation in Type 2 Diabetes Mellitus
Sponsor:
Istanbul Kent University
Organization:
Istanbul Kent University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 hisher 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 individuals 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None