Back to resultsThe Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathies, Diabetes Mellitus, Exercise Training
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Biodex Balance Exercise System
Sponsored by
About this trial
This is an interventional screening trial for Diabetic Neuropathies
Eligibility Criteria
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
Sites / Locations
- Dokuz Eylul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Biodex Balance Group
Control Group
Arm Description
This group performed exercises using the biodex balance system
This group was informed about diabetes self-management.
Outcomes
Primary Outcome Measures
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.
The effect of biodex balance training on protective senses
Protective senses was assessed with monofilament and 128 Hz tuning fork
The effect of biodex balance training on motor nerves
Nerve conduction test was assessed with electromyograph
Secondary Outcome Measures
Full Information
NCT ID
NCT05255497
First Posted
February 16, 2022
Last Updated
February 24, 2022
Sponsor
Duygu AKTAR REYHANIOGLU
1. Study Identification
Unique Protocol Identification Number
NCT05255497
Brief Title
The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy
Official Title
Effects of Balance Exercises in Diabetic Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2, 2017 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
September 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Duygu AKTAR REYHANIOGLU
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies, Diabetes Mellitus, Exercise Training
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biodex Balance Group
Arm Type
Experimental
Arm Description
This group performed exercises using the biodex balance system
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group was informed about diabetes self-management.
Intervention Type
Device
Intervention Name(s)
Biodex Balance Exercise System
Intervention Description
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.
Primary Outcome Measure Information:
Title
The effect of biodex balance training on muscle strength was evaluated.
Description
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
Title
The effect of biodex balance training on protective senses
Description
Protective senses was assessed with monofilament and 128 Hz tuning fork
Time Frame
Change from baseline to 8 weeks
Title
The effect of biodex balance training on motor nerves
Description
Nerve conduction test was assessed with electromyograph
Time Frame
Change from baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaye Yıldırım, Dr
Organizational Affiliation
Dokuz Eylul University
Official's Role
Study Chair
Facility Information:
Facility Name
Dokuz Eylul University
City
İzmir
State/Province
Balcova/Incialtı
ZIP/Postal Code
35340
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy
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