The Effect of Foot and Ankle Exercise on Pain and Quality of Life in Patients With Diabetic Neuropathy

March 2, 2026 updated by: Ülkü Görgülü Polat, Gazi University
The study will be carried out to determine the effect on pain and quality of life between the groups that received and did not receive foot and ankle exercise training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the literature, in patients with diabetic neuropathy who received foot and ankle exercise training; It is observed that it reduces the level of pain and increases the quality of life. Foot and ankle exercise training given to the participants improved blood circulation, improved foot-ankle range of motion, increased foot muscle strength and function, improved diabetic neuropathy symptoms, redistributed plantar pressure during movement, improved sensitivity, and was effective in maintaining balance; It is thought that participants can reduce pain and improve their quality of life with foot and ankle exercise training. While there are studies examining the effect of non-pharmacological interventions such as spa treatment and pulse electromagnetic field therapy in patients with diabetic neuropathy in our country, no study has been found examining the effect of foot and ankle exercise training on pain and quality of life in patients with diabetic neuropathic pain. It is thought that the results of the research will be beneficial in symptom management and improve quality of life in addition to pharmacological treatment.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years and over,
  • Having been diagnosed with Type 2 diabetes for at least one year,
  • Diagnosed with diabetic peripheral neuropathy for at least 6 months by EMG by a neurologist,
  • Individuals with diabetes mellitus with neuropathic pain who score 12 or higher on the S-Lanns (Self-Leeds Assessment of Neuropathic Symptoms and Sign) pain scale,
  • Visual Analogue Scale (VAS) value to be at least 1,
  • Receiving medical treatment for diabetic neuropathy,
  • Did not receive physical therapy and non-pharmacological treatment during the research period,
  • Having no physical and mental problems that will prevent communication,
  • Having blood glucose meters at home,
  • Individuals with smart device use,

Exclusion Criteria:

  • Peripheral vascular complications due to diabetes or another etiology,
  • Having a history of surgery on the knee, ankle and hip and indication for surgery during the intervention period,
  • Those who cannot communicate on the phone (with hearing problems),
  • Having nephropathy, retinopathy and diabetic foot,
  • Neurological diseases (stroke, cerebrovascular diseases, epilepsy) and serious musculoskeletal problems (rheumatoid arthritis, osteoarthritis)
  • Neurocognitive disorder (Alzheimer's disease, dementia),
  • Not taking any physical therapy during the intervention period,
  • Patients with deep vein thrombosis, femur fractures, surgical conditions, open wounds

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
The intervention group received training by sending foot and ankle exercise videos to their mobile phones via WhatsApp.
Other: foot and ankle exercise

Foot and Ankle Exercise Phase

  1. Pulling the foot upwards from the ankle
  2. Bending the foot down from the ankle
  3. Spreading the feet like a fan, moving the toes in and out to the right and left
  4. Circle drawing exercise with ankle
  5. Towel folding exercise
  6. Bottle rolling exercise under the feet (The water in the bottle will be warm tap water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain level at 4th and 8th weeks compared to baseline.
Time Frame: Two months
Pain scores of the patients were checked after foot and ankle exercise training. The scale, developed by Price, McGrath, Rafii, and Buckingham, is a measurement tool that evaluates pain severity. The scale is 10 cm long and is graded on a horizontal line (0 = no pain, 10 = most severe pain). The patient is asked to mark a point on this line that corresponds to the intensity of pain he feels. The marked numerical value indicates the severity of the patient's perception of pain. A VAS value of 1 to 4 indicates mild pain, 5-6 indicates moderate pain, and 7-10 indicates severe pain. As scores increase, the level of pain worsens and general health deteriorates.
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of neuropathic pain on quality of life at 4 and 8 weeks change from initial state
Time Frame: Two months
After the interventions, the patient's scores on the effect of neuropathic pain on quality of life are checked. Poole, Murphy, and Nurmka (2009) developed a questionnaire on the impact of neuropathic pain on quality of life. The scale consisting of 42 items; symptoms were divided into 6 subscales under the headings of relationships, psychological, social activity, physical activity, and personal/self care. The results of the questionnaire on the effect of neuropathic pain on the quality of life were calculated by summing the 42-item scores. The total score range is between 42 and 210. The score range for each item is between 1 and 5.
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Principal Investigator: Ülkü Polat, Prof., Gazi University
  • Principal Investigator: Selin Çiftçi, Gazi University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

March 29, 2022

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

January 1, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gaziüniversite

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

all IPD underlying results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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