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NCT06979401Not yet recruiting

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

Effects of Foot Sensory Training on Plantar Sensation, Functional Performance, Balance, Gait and Kinesiophobia in Type 2 Diabetic Individuals With Neuropathy

Source: ClinicalTrials.gov · Last updated 19 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
10 May 2025
Start date
15 Jun 2025
Primary completion date
15 Aug 2025
Lead sponsor
Aylin DEMİR
NCT number
NCT06979401

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 15 Jun 2025 to the primary completion date, 15 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Using medications known to affect the postural control system such as benzodiazepines

Other illness

  • Having a respiratory disease such as uncontrolled COPD or asthma

Other

  • Having a neurological or orthopedic comorbidity
  • Having active lower extremity ulceration
  • 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

Who the study is looking for

  • 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

Age in the registry: 35 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Inonu University
Coordinator of this site? Confirm its status
MalatyaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.