Clinical trial NCT06979401: Effect of Sensory Training on Functional Performance, Balance, Gait in Type 2 Diabetic Individuals With Neuropathy
Official title: Effects of Foot Sensory Training on Plantar Sensation, Functional Performance, Balance, Gait and Kinesiophobia in Type 2 Diabetic Individuals With Neuropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes
Type 2 Diabetes
Diabetic Peripheral Neuropathy
Kinesiophobia
Balance
Functional Performance
Gait Analysis
Plantar Sensation
Keywords: balance
Plantar Sensation
type 2 diabetes
gait
kinesiophobia
functional performance
diabetic peripheral neurophaty
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Diabetic peripheral neuropathy (DPN) is a common complication of type 1 and type 2 diabetes. DPN is characterized by significant axonal degeneration and segmental demyelination affecting sensory and motor nerves. The effect of foot sole sensation on gait and balance parameters has been reported in various studies in the literature, however, no study has been found examining the effect of foot sensory training on plantar sensation, functional performance, balance, gait and kinesiophobia in type 2 diabetic individuals with neuropathy. In order to contribute to the literature, 40 type 2 diabetic individuals with neuropathy who applied to the Turgut Ozal Medical Center Endocrinology and Metabolic Diseases Polyclinic will be included in this randomized controlled study. After diabetic foot training is given to all participants, an experimental (20) and a control (20) group will be formed with a sequential random method. Foot sensory training will be given to the experimental group, while no intervention will be made to the control group, and sensory training will be given to the participants who wish after the study is completed. All participants will be evaluated for subscapular sense, functional performance, balance, walking and kinesiophobia at the beginning and end of the training. Subscapular sense will be evaluated with light touch, two-point discrimination and vibration tests. Functional performance evaluation will be made with timed up and go test and timed stair ascent-descend test. Kinesiophobia will be analyzed with Tampa Kinesiophobia Scale, Balance; One-Legged Stand Test and Y balance tests and walking will be analyzed with Kinect V2 camera based software. Physical activity levels will be evaluated with International Physical Activity Questionnaire-Short Form. The data taken into the research will be analyzed with SPSS (Statistical Program in Social Sciences) program. The values belonging to the data will be expressed with percentage, mean and standard deviation, and the significance level (p) will be taken as 0.05 for comparison tests.

Detailed description: Type 2 diabetes (T2D) is a chronic metabolic disease that develops as a result of insufficiency of insulin itself or its action. Diabetic peripheral neuropathy (DPN), a common complication of type 2 diabetes, results from metabolic and microvascular changes as a consequence of prolonged hyperglycemia and metabolic derangements.

Diabetic peripheral neuropathy is associated with damage to small unmyelinated and myelinated nerve fibers, resulting in impaired sensations of touch, pain and temperature. Damage to large myelinated nerve fibers results in decreased sensation of vibration and proprioception. Sole sensation is an important parameter for posture and gait control. When the afferent inputs of the foot are not properly transmitted to the central nervous system, a lack of balance develops reciprocally.

Functional performance refers to some activities and behaviors in daily life that individuals can perform up to a certain level. In individuals with diabetes mellitus with neuropathy, it is reported that there are decreases in functional performance as well as strength losses and decreases in joint mobility, especially in the dorsal and plantar foot muscles.

Involving both sensory and motor fibers, DPN causes balance and gait disturbances and neuropathic pain. As a result of altered gait biomechanics and balance disorders, individuals with diabetes have an increased risk of falling, perception of imbalance and fear of falling. This leads to physical inactivity and loss of muscle strength. It leads to further impairment of gait and balance biomechanics.

Kinesiophobia is the patient's fear of physical movement as well as negative cognitive and emotional response to anticipated or actual pain. It is expressed as a condition describing actions resulting from a feeling of vulnerability to re-injury. Impaired balance and fear of falling initiate kinesiophobia in people. As a result, restriction in physical activities increases. The number of studies examining kinesiophobia in individuals with diabetes is very limited. In one study, it was stated that individuals with diabetic neuropathy had an increase in kinesiophobia in balance disorders.

When the studies conducted with type 2 diabetic individuals with neuropathy were examined in the literature, no study providing foot sensory training was found. In this study, we aimed to investigate the effect of foot sensory training on underfoot sensation, functional performance, balance, gait and kinesiophobia in type 2 diabetic individuals with neuropathy. This study will provide data and contribution to fill this gap in the literature.

Eligibility criteria: Inclusion Criteria:

* Being 35-65 years old
* Being diagnosed with type 2 diabetes
* Having achieved glycemic control
* Having given less than 8 correct answers in the Semmes-Weinstein Monofilament test performed with a 5.07 monofilament
* Getting a Neuropathy Disability Score of 3 and above
* Being willing to participate in the study
* Being literate

Exclusion Criteria:

* Having a neurological or orthopedic comorbidity
* Having a respiratory disease such as uncontrolled COPD or asthma
* Having active lower extremity ulceration
* Using medications known to affect the postural control system such as benzodiazepines
* Having nephropathy, retinopathy and diabetic arthritis at a level that may affect mobility in addition to neuropathy
* Using a walking aid
* Body Mass Index \>30
* Having communication problems
* Not participating in at least 3 consecutive exercise sessions
* Not participating in more than 30% of each session

Primary outcomes:
measure: Tampa Kinesiophobia Scale
timeFrame: 6 week
measure: Evaluation of Light touch sense
timeFrame: 6 week
measure: Timed Up and Go Test
timeFrame: 6 week
measure: Single Leg StanceTest
timeFrame: 6 week
measure: Gait Analysis
timeFrame: 6 week
measure: Evaluation of vibration sense
timeFrame: 6 week
measure: Evaluation of Two-point discrimination sense
timeFrame: 6 week
measure: Stair Climb Test
timeFrame: 6 week
measure: Y Balance test
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: İnonu University
state: Battalgazi
Study officials:
References: