Effect of Sensory Training on Functional Performance, Balance, Gait in Type 2 Diabetic Individuals With Neuropathy

NCT ID: NCT06979401

Last Updated: 2025-05-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2025-12-15

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.

Conditions

Diabetes; Type 2 Diabetes; Diabetic Peripheral Neuropathy; Kinesiophobia; Balance; Functional Performance; Gait Analysis; Plantar Sensation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention

After obtaining informed consent to participate in the study, all participants will be evaluated by an experienced physiotherapist before group allocation. All participants will receive diabetic foot training. Then, the intervention group and the control group will be formed by a sequential random method. Foot sensory training will be applied to the intervention group and no intervention will be made to the control group. However, after the study is completed, sensory training will be provided to the participants in the control group who wish to do so. Foot sensory training will be performed by the researcher physiotherapist. Foot sensory training sessions will be planned for 6 weeks, 3 days a week. An initial assessment will be made before the sessions begin and a final assessment will be made after the 6-week foot sensory training program.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

After obtaining informed consent to participate in the study, all participants will be evaluated by an experienced physiotherapist before group allocation. All participants will receive diabetic foot training. Then, the experimental group and the control group will be formed by a sequential random method. Foot sensory training will be applied to the experimental group and no intervention will be made to the control group. However, after the study is completed, sensory training will be provided to the participants in the control group who wish to do so. Foot sensory training will be performed by the researcher physiotherapist. Foot sensory training sessions will be planned for 6 weeks, 3 days a week. An initial assessment will be made before the sessions begin and a final assessment will be made after the 6-week foot sensory training program.

Control

Individuals who agree to participate in the study and meet the inclusion criteria will be asked for written consent with a consent form. The researcher will meet with the participants one-on-one and provide information about the purpose of the study. The pre-test data of the study will be collected by an experienced physiotherapist before group allocation. All participants will receive diabetic foot training. Then, the intervention group and the control group will be formed with a sequential random method. Individuals in the control group will not receive any intervention and will continue their standard drug treatments for diabetes. Post-test data will be collected after the 6-week sensory training given to the intervention group. They will only complete the pre-test and post-test and will not participate in sensory training. Their data will be used for comparison purposes to evaluate the effectiveness of the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

After obtaining informed consent to participate in the study, all participants will be evaluated by an experienced physiotherapist before group allocation. All participants will receive diabetic foot training. Then, the experimental group and the control group will be formed by a sequential random method. Foot sensory training will be applied to the experimental group and no intervention will be made to the control group. However, after the study is completed, sensory training will be provided to the participants in the control group who wish to do so. Foot sensory training will be performed by the researcher physiotherapist. Foot sensory training sessions will be planned for 6 weeks, 3 days a week. An initial assessment will be made before the sessions begin and a final assessment will be made after the 6-week foot sensory training program.

Intervention Type: OTHER

Other Intervention Names

foot sensory training

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aylin DEMİR

OTHER

Sponsor Role: lead

Responsible Party

Aylin DEMİR

RESEARCH ASSISTANT

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

İnonu University

Malatya, Battalgazi, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Aylin Demir, research assistant

Role: CONTACT

ayln.dmir@gmail.com

+904382126213

Facility Contacts

Filiz Özdemir, Associate Professor

Role: primary

filiz.ciledag@inonu.edu.tr

+904223410219

Other Identifiers

2025/7046

Identifier Type: -

Identifier Source: org_study_id