The Effect of Foot and Ankle Exercise o… | Clinical Trial

Key information

Conditions

Diabetic Neuropathy, Painful Behavior Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Motor Activity Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toros Devlet Hastanesi

Mersin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

foot and ankle exercise

Other

Foot and Ankle Exercise Phase

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

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2022
First posted: Jan 4, 2023
Registry last updated: Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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