The Effect of Hand and Foot Exercises Combined With Cold Application or Virtual Reality on Diabetic Neuropathy

NCT07085130 | Active Not Recruiting

• 1 other identifier: SAU-hand and foot exercises
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be conducted to determine the effect of cold application and virtual reality (VR) or combined hand and foot exercises on pain intensity, kinesiophobia, and fragility levels in patients with diabetic peripheral neuropathy.

Conditions

Diabetic Peripheral Neuropathy

Keywords

diabetic peripheral neuropathy; hand and foot exercises; cold application; virtual reality; kinesiophobia; fraility; neuropatic pain

Outcome Measures

Primary Outcomes (3)

• Changes in kinesiophobia

  As a result of the intervention, the Tampa Kinesiophobia Scale will be used to evaluate the differences and effects between the intervention and control groups in terms of fear of movement levels. The Turkish validity and reliability study of the scale developed by Miller and colleagues (1991) was conducted by Yılmaz and colleagues (2011). The TKÖ is a 17-item scale developed to measure fear of movement/re-injury. Each question in the scale uses a 4-point Likert scale (1 = Strongly disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Strongly agree). The total score obtained from the questionnaire ranges from 17 to 68. A high score on the scale indicates a high level of kinesiophobia.

  At the end of eight weeks

• Change in the neuropathic pain levels

  Following an eight-week intervention, the Douleur Neuropathique en 4-DN4 questionnaire will be used to assess whether there has been a reduction in patients' neuropathic pain levels. The DN4 pain questionnaire, developed by a neuropathic pain group, consists of four questions that inquire about the characteristics, type, location, and aggravating factors of neuropathic pain. According to the scale, neuropathic pain is assessed with a total of four questions, the first two of which are based on direct interviews with the patient and the last two on the patient's clinical examination. The Turkish validity and reliability study was conducted by Ünal Çevik and colleagues (2010). The questions in the questionnaire are answered with "yes" or "no." Each 'yes' answer is scored as 1 point, and each "no" answer is scored as 0 points. According to the scale, the threshold value for neuropathic pain is set at 4/10 or higher.

  at the end of eight weeks

• Change in fraility

  As a result of the intervention, the fragility levels of patients with diabetic peripheral neuropathy will be assessed using the Tilburg Fraility Scale. The Turkish validity and reliability study of the scale developed by Gobbens and colleagues (2010) was conducted by Arslan and colleagues (2018). The TKÖ consists of 15 questions and 3 sub-dimensions that assess vulnerability. The scale includes 8 questions that assess the physical domain, 4 questions that assess the psychological domain, and 3 questions that assess the social domain. Eleven items of the TKÖ are evaluated in two categories: "Yes" and "No." Four items of the TKÖ are scored as "yes," "sometimes," and "no." The total score that can be obtained from the scale ranges from 0 to 15, with scores of 5 and above indicating the presence of vulnerability.

  At the end of eight weeks

Study Arms (4)

Intervention: Cold Application

EXPERIMENTAL

Patients in the cold application intervention group will be evaluated during the first week and data collection forms will be completed. They will perform the hand and foot exercises in the exercise video three days a week, after which cold compress bags will be applied to their hands and feet for 5-10 minutes. They will be cooled to -25 to -30 °C for at least 3 hours before use.

Behavioral: Exercises and cold application

Intervention: Virtual Reality

EXPERIMENTAL

Patients in the virtual reality intervention group will be evaluated during the first week and data collection forms will be completed. The virtual reality application will be taught through explanation and demonstration. The researcher will accompany the patients and the glasses and headphones will be put on the patient in a comfortable sitting position. As part of the application, patients will attempt to perform hand and foot exercises for an average of 15 minutes in a virtual environment accompanied by snowy landscapes and snow-themed sounds. The patient will be observed by the researcher during the application, and if symptoms such as dizziness, headache, or discomfort occur during the virtual reality application, the application will be terminated. Patients in the virtual reality intervention group will perform the virtual reality application three times a week for eight weeks. Patients will record their virtual reality applications in the Virtual Reality Application Diary.

Other: Exercises and virtual reality

Control

NO INTERVENTION

Patients in the control group will be allocated time similar to the intervention flow applied to the intervention groups, and diabetic peripheral neuropathy will be explained. In this context, the control group patients will be evaluated in the first week, data collection forms will be filled out, and neuropathy management training will be explained by the researcher. The content of the presentation will cover the treatment and management of diabetic neuropathy.

Intervention: Hand and foot exercises

EXPERIMENTAL

In this study, hand and foot exercises will be combined with both cold application and virtual reality, and both intervention groups will perform these exercises. Patients will perform hand and foot exercises approximately three times a week for about 15 minutes. Hand and foot exercises are an easy-to-perform, low-cost type of exercise designed to relieve individuals who experience numbness and tingling-like pain. Patients will perform hand movements such as the snail movement, making a full and half fist, the claw movement, and rolling a ball. For foot exercises, they will perform movements such as crumpling a towel, rolling a ball, and spreading the toes.

Behavioral: Exercises and cold application; Other: Exercises and virtual reality

Interventions

Exercises and cold application BEHAVIORAL

Hand and foot exercises combined with cold application interventions are non-pharmacological methods used to reduce pain, kinesiophobia, and fragility levels in patients with diabetic peripheral neuropathy.

Also known as: cold application, hand and foot exercises

Intervention: Cold Application; Intervention: Hand and foot exercises

Exercises and virtual reality OTHER

Performing hand and foot exercises in a cold, snowy virtual environment using virtual reality goggles may be a non-pharmacological intervention to alleviate burning-type hand and foot pain in patients with diabetic neuropathy.

Also known as: virtual reality, hand and foot exercises

Intervention: Hand and foot exercises; Intervention: Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who volunteer to participate in the study
• Those who have been diagnosed with diabetes at least 6 months ago
• Those who show symptoms of neuropathy
• Those over the age of 18
• Those without cognitive or psychiatric diagnoses
• Those who are open to communication and cooperation
• Those who use a smartphone

You may not qualify if:

• Those with neurological disorders other than neuropathy
• Those with any additional orthopedic or systemic disorders that would prevent them from performing the exercises
• Those who have had a lower extremity pathology (surgery, fracture, soft tissue injury, etc.) in the past 6 months
• Those who are pregnant during the study period
• Those who wish to withdraw from the study of their own accord

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya University

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesiophobia

Interventions

Exercise; Exergaming

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Busra Gurcay, Research Assistant

  Sakarya University Health Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: In terms of the reliability of the study results, patients in this study will be divided into groups using a stratified randomization method. Patients will be randomly assigned to two intervention (I) and one control (C) groups according to their age.

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 25, 2025
• Study Start: June 25, 2025
• Primary Completion: December 25, 2025
• Study Completion: December 25, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)