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

February 24, 2022 updated by: Duygu AKTAR REYHANIOGLU

Effects of Balance Exercises in Diabetic Peripheral 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

27

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

  • Turkey
    • Balcova/Incialtı
      • İzmir, Balcova/Incialtı, Turkey, 35340
        • Dokuz Eylül University

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

45 years to 76 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Biodex Balance Group
This group performed exercises using the biodex balance system
Device: Biodex Balance Exercise System
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.
NO_INTERVENTION: Control Group
This group was informed about diabetes self-management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline to 8 weeks
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
Change from baseline to 8 weeks
The effect of biodex balance training on motor nerves
Time Frame: Change from baseline to 8 weeks
Nerve conduction test was assessed with electromyograph
Change from baseline to 8 weeks

Collaborators and Investigators

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

Sponsor

Duygu AKTAR REYHANIOGLU

Investigators

  • Study Chair: Gaye Yıldırım, Dr, Dokuz Eylül University

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)

September 2, 2017

Primary Completion (ACTUAL)

June 10, 2019

Study Completion (ACTUAL)

September 20, 2020

Study Registration Dates

First Submitted

February 16, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (ACTUAL)

February 24, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2022

Last Update Submitted That Met QC Criteria

February 24, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IzmirTinaztepeU

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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