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

Sponsor
Duygu AKTAR REYHANIOGLU (Other)
Overall Status
Completed
CT.gov ID
NCT05255497
Collaborator
(none)
27
1
2
36.6
0.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Biodex Balance Exercise System
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
27 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
Effects of Balance Exercises in Diabetic Peripheral Neuropathy
Actual Study Start Date :
Sep 2, 2017
Actual Primary Completion Date :
Jun 10, 2019
Actual Study Completion Date :
Sep 20, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. The effect of biodex balance training on motor nerves [Change from baseline to 8 weeks]

    Nerve conduction test was assessed with electromyograph

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 76 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dokuz Eylul University İzmir Balcova/Incialtı Turkey 35340

Sponsors and Collaborators

  • Duygu AKTAR REYHANIOGLU

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duygu AKTAR REYHANIOGLU, Principal Investigator, Izmir Tinaztepe University
ClinicalTrials.gov Identifier:
NCT05255497
Other Study ID Numbers:
  • IzmirTinaztepeU
First Posted:
Feb 24, 2022
Last Update Posted:
Mar 11, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 11, 2022