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NCT Number: NCT05255497

The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy

This study examined the effects of balance exercises performed with the Biodex Balance System (BBS) on nerve conduction, sensory symptoms, and muscle strength in patients with diabetes-related neuropathy.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Exercise Training Glucose Metabolism Disorders Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases

Age range

45 year–76 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, Balcova/Incialtı, 35340, Turkey (Türkiye)

About this study

We enrolled twenty-seven patients in this study. Patients in the intervention group (n=14) performed exercises using the computerized BBS. The control group (n=13) was just informed about diabetes self-management. All patients underwent pretest and posttest peripheral nerve conduction studies. Sensory examination performed by using 5.07 Semmes-Weinstein monofilaments and 128-Hz tuning fork. Muscle strength measurements obtained with manual dynamometer

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction study

Exclusion criteria

  • increased risk of non-diabetes related neuropathy: history of autoimmune, cerebrovascular, or chronic infectious disease, cancer, chemotherapy and/or radiotherapy, radicular neuropathy, chronic kidney and liver failure, alcoholism or other substance abuse, and mental or physical disabilities (including blindness). We also excluded patients who didn't speak Turkish

Treatment and study plan

Biodex Balance Exercise System

Device

Patients in the intervention group (n=14) performed exercises using the computerized BBS. The control group (n=13) was just informed about diabetes self-management.

Primary outcomes

  1. The effect of biodex balance training on muscle strength was evaluated.

    Time frame: Change from baseline to 8 weeks

    Muscle test was evaluated with a manual dynamometer. The measurements of both groups before and after the training were compared.

  2. The effect of biodex balance training on protective senses

    Time frame: Change from baseline to 8 weeks

    Protective senses was assessed with monofilament and 128 Hz tuning fork

  3. The effect of biodex balance training on motor nerves

    Time frame: Change from baseline to 8 weeks

    Nerve conduction test was assessed with electromyograph

Sponsors and collaborators

Lead sponsor

Duygu AKTAR REYHANIOGLU

Other

Registry information

Official study title

Effects of Balance Exercises in Diabetic Peripheral Neuropathy

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Feb 24, 2022
Registry last updated
Mar 11, 2022

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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