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

Diabetes Mellitus Clinical Trial

Official title:

Effects of Balance Exercises in Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05255497
• Other study ID #: IzmirTinaztepeU
• Status: Completed
• Phase: N/A
• Start date: September 2, 2017
• Est. completion date: September 20, 2020

Study information

• Verified date: February 2022
• Source: Izmir Tinaztepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 20, 2020
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Neuropathies
• Exercise Training

Intervention

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.

Locations

Country	Name	City	State
Turkey	Dokuz Eylul University	Izmir	Balcova/Incialti

Sponsors (1)

Lead Sponsor	Collaborator
Duygu AKTAR REYHANIOGLU

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to 8 weeks
Primary	The effect of biodex balance training on protective senses	Protective senses was assessed with monofilament and 128 Hz tuning fork	Change from baseline to 8 weeks
Primary	The effect of biodex balance training on motor nerves	Nerve conduction test was assessed with electromyograph	Change from baseline to 8 weeks