CClinicalTrials.gg
CompletedNCT05255497Updated Mar 11, 2022

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

An interventional study of Biodex Balance Exercise System in Diabetic Neuropathies, Diabetes Mellitus and Exercise Training, sponsored by Duygu AKTAR REYHANIOGLU. Completed at 1 site in Turkey. Open to participants aged 45 Years to 76 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-11.

Sponsored by Duygu AKTAR REYHANIOGLU · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 4 years 5 months after the study started (first participant enrolled Sep 2017, registered Feb 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
45 Years to 76 Years
Sex
All
01

Study summary

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.

Read the 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

02

Conditions studied

  • Diabetic Neuropathies
  • Diabetes Mellitus
  • Exercise Training

Browse trials for

03

In context

Diabetic Neuropathies

617 studies on the registry are indexed under Diabetic Neuropathies; 91 are open to participants now.

This study's enrollment of 27 is below the median of 73 across 510 interventional studies indexed under Diabetic Neuropathies.

Browse Diabetic Neuropathies studies →

Lead sponsor

This is the only study on the registry with Duygu AKTAR REYHANIOGLU as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 76 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Biodex Balance Group

    This group performed exercises using the biodex balance system

    Device: Biodex Balance Exercise System

  • No intervention
    Control Group

    This group was informed about diabetes self-management.

Interventions

  • DeviceBiodex 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.

06

What researchers measure

Primary outcomes

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

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

    Time frame: Change from baseline to 8 weeks

  2. The effect of biodex balance training on protective senses

    Protective senses was assessed with monofilament and 128 Hz tuning fork

    Time frame: Change from baseline to 8 weeks

  3. The effect of biodex balance training on motor nerves

    Nerve conduction test was assessed with electromyograph

    Time frame: Change from baseline to 8 weeks

07

Study locations

1 site
  • Dokuz Eylul University
    İzmir, Balcova/Incialtı 35340, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05255497
Lead sponsor
Duygu AKTAR REYHANIOGLU
Responsible party
Duygu AKTAR REYHANIOGLU (Principal Investigator, Izmir Tinaztepe University) — Sponsor-investigator
First posted
Feb 24, 2022
Start date
Sep 2, 2017
Primary completion
Jun 10, 2019
Completion
Sep 20, 2020
Last update
Mar 11, 2022

Study contacts

Gaye Yıldırım, Dr
study chair · Dokuz Eylul University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion