The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy
Effects of Balance Exercises in Diabetic Peripheral Neuropathy
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2020
CompletedFirst Submitted
Initial submission to the registry
February 16, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedMarch 11, 2022
February 1, 2022
1.8 years
February 16, 2022
February 24, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
The effect of biodex balance training on motor nerves
Nerve conduction test was assessed with electromyograph
Change from baseline to 8 weeks
Study Arms (2)
Biodex Balance Group
EXPERIMENTALThis group performed exercises using the biodex balance system
Control Group
NO INTERVENTIONThis group was informed about diabetes self-management.
Interventions
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.
Eligibility Criteria
You may qualify if:
- diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dokuz Eylul University
Izmir, Balcova/Incialtı, 35340, Turkey (Türkiye)
Related Publications (1)
Reyhanioglu DA, Yildirim G, Sengun IS, Kara B. Effects of Computer-based Balance Exercises on Balance, Pain, Clinical Presentation and Nerve Function in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Study. J Musculoskelet Neuronal Interact. 2024 Jun 1;24(2):168-177.
PMID: 38825999DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Gaye Yıldırım, Dr
Dokuz Eylul University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 16, 2022
First Posted
February 24, 2022
Study Start
September 2, 2017
Primary Completion
June 10, 2019
Study Completion
September 20, 2020
Last Updated
March 11, 2022
Record last verified: 2022-02