Diabetic NeuropathiesNCT05255497
The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy
A study testing Biodex Balance Exercise System in people with Diabetic Neuropathies and Diabetes Mellitus, run by Duygu AKTAR REYHANIOGLU at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 45 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Neuropathies, Diabetes Mellitus, Exercise Training
- What is being tested?
- Biodex Balance Exercise System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2017to 20 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University
Izmir, Balcova/Incialtı, 35340
About this study
Official title: Effects of Balance Exercises in Diabetic Peripheral Neuropathy
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.
Read the 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
- Conditions
- Diabetic Neuropathies, Diabetes Mellitus, Exercise Training
- Being tested
- Biodex Balance Exercise System
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex Balance Exercise SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Biodex Balance Group | Experimental | This group performed exercises using the biodex balance system Receives: Device: Biodex Balance Exercise System |
| Control Group | No intervention | This group was informed about diabetes self-management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Change from baseline to 8 weeks
The effect of biodex balance training on motor nerves
Nerve conduction test was assessed with electromyograph
Measured: Change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start2 Sep 2017
- Primary completion10 Jun 2019
- Study completion20 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duygu AKTAR REYHANIOGLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Duygu AKTAR REYHANIOGLU, Izmir Tinaztepe University
- Investigators
- Gaye Yıldırım, Dr, Study chair, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255497
- Sponsor's protocol ID
- IzmirTinaztepeU
- Status last verified
- Feb 2022
- First submitted
- 16 Feb 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38825999
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Balance Exercises in Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT05255497
- Acronym / sponsor ID
- IzmirTinaztepeU
- Conditions
- Diabetic Neuropathies, Diabetes Mellitus, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Duygu AKTAR REYHANIOGLUUniversity, hospital or other
- Study start
- 2 Sep 2017 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 20 Sep 2020 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biodex Balance Group | Experimental | Device: Biodex Balance Exercise SystemThis group performed exercises using the biodex balance system |
| Control Group | No intervention | –This group was informed about diabetes self-management. |
Who may qualify
- Ages
- 45 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction study
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biodex Balance Exercise SystemPatients in the intervention group (n=14) performed exercises using the computerized BBS. The control group (n=13) was just informed about diabetes self-management. | Device | Biodex Balance Group |
Primary outcome
The effect of biodex balance training on muscle strength was evaluated.
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 8 weeks
Nerve conduction test was assessed with electromyograph
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 38825999Reyhanioglu 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.
Related trials for Diabetic Neuropathies
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaye Yıldırım, Dr study chair
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodex Balance Exercise System in people with Diabetic Neuropathies and Diabetes Mellitus, run by Duygu AKTAR REYHANIOGLU at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of biodex balance training on muscle strength was evaluated. (time frame: Change from baseline to 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05255497, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.