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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Diabetic Neuropathies; Exercise Training
• Interventions: Device: Biodex Balance Exercise System

• Registration Number: NCT05255497
• Lead Sponsor: Duygu AKTAR REYHANIOGLU

Brief 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.

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 Timeline

• Study Start: 2017-09-02
• Primary Completion: 2019-06-10
• Study Completion: 2020-09-20
• Status Verified: 2022-02
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-24
• Last Update Submitted: 2022-02-24
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biodex Balance Group	Biodex Balance Exercise System	This group performed exercises using the biodex balance system

Primary Outcome Measures

Name	Time	Method
The effect of biodex balance training on muscle strength was evaluated.	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.
The effect of biodex balance training on protective senses	Change from baseline to 8 weeks	Protective senses was assessed with monofilament and 128 Hz tuning fork
The effect of biodex balance training on motor nerves	Change from baseline to 8 weeks	Nerve conduction test was assessed with electromyograph

Trial Locations

Locations (1)

Dokuz Eylul University; 🇹🇷 İzmir, Balcova/Incialtı, Turkey