Diabetus MellitusNCT06878651
The Instant Effect of Whole Body Vibration in Diabetics
A study testing The Whole Body Vibration in people with Diabetus Mellitus and Diabetic Foot Ulcer, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Overview of Diabetes and Its Complications: Diabetes is a chronic health issue that can lead to various complications, affecting human health negatively. One of these complications is diabetic peripheral neuropathy (DPN), which results from hyperglycemia and affects peripheral nerves. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetus Mellitus, Diabetic Foot Ulcer, Diabetic Neuropathic Ulcer
- What is being tested?
- The Whole Body Vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients aged 40-75 years,
- Having a score of 13-29 on the Michigan Questionnaire (intermediate level),
- Having a Mini Mental Test score of 24 and above,
- Having an HbA1C <8.5%, having controlled blood glucose levels in the last three months,
- Being able to walk independently
- Volunteering to participate in the study.
Who cannot join
- Those with diabetic infected wounds,
- Those with neurological diseases other than diabetic neuropathy,
- Those with rheumatoid arthritis, vestibular system disorders, visual
- Impairments, those with a history of trauma, injury and surgery,
- Those with knee or hip replacement,
- Those with a history of epilepsy and cognitive problems.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gülhane Eğitim ve Araştırma Hastanesi
Ankara, Ankara, 06300
About this study
Official title: Investigation of the Immediate Effects of Whole Body Vibration Training on Balance, Dual Task and Gait in Individuals with Diabetic Neuropathy
Overview of Diabetes and Its Complications:
- Diabetes is a chronic health issue that can lead to various complications, affecting human health negatively. One of these complications is diabetic peripheral neuropathy (DPN), which results from hyperglycemia and affects peripheral nerves. This can lead to sensory loss, motor dysfunction, and ultimately, disability.
- The complications from diabetes can result in the loss of function and disability, affecting various systems, including the nervous system (e.g., retinopathy, neuropathy, and atherosclerosis).
Read more
Peripheral Neuropathy in Diabetes:
- DPN occurs due to damage to peripheral nerves caused by hyperglycemia. Over time, it affects the small unmyelinated fibers responsible for pain and temperature sensations, leading to axonal degeneration and demyelination, causing sensory loss.
- In later stages, motor dysfunction can also occur, impacting intrinsic foot muscles, leading to muscle weakness and atrophy.
Whole Body Vibration (WBV) Therapy:
- WBV is a therapeutic method that uses mechanical vibrations from a vibrating platform to stimulate muscle contractions. It is being researched for its effects on managing diabetic neuropathy and related complications.
- Studies have shown that WBV can improve balance, functional independence, and postural stability in patients with diabetes, potentially serving as an alternative or complement to traditional balance exercises.
- A randomized controlled trial compared the effects of WBV and Tai Chi on postural balance and found that WBV was more effective in promoting functional independence and balance.
Impact on Sensory Function and Balance:
- As DPN progresses, sensory loss may prevent patients from noticing injuries, which could lead to severe complications. A study conducted in 2017 showed that WBV improved vibration perception thresholds (VPT) in patients with type 2 diabetes and peripheral neuropathy, indicating improved sensory function, which is crucial for maintaining balance and walking.
- This improvement is thought to be linked to increased blood circulation in peripheral tissues and improved glucose levels due to WBV therapy.
Dual Task Performance and WBV:
- Dual-task performance, which involves performing cognitive and motor tasks simultaneously, is typically impaired in patients with diabetic neuropathy, leading to difficulties in daily activities. WBV has shown potential in improving muscle strength and balance, which could enhance patients' ability to perform dual tasks more effectively.
Research Findings:
- Several studies have demonstrated that WBV training can significantly improve both static and dynamic balance in patients with diabetic neuropathy. Given that balance issues are common in these patients and contribute to a higher risk of falls, these improvements are particularly important.
- The literature emphasizes the need for continued research to clarify the physiological mechanisms behind WBV's effects on sensory feedback mechanisms, which are essential for postural control.
Need for Further Research:
- Despite promising findings, some studies have pointed out the need for more research to validate the clinical efficacy of WBV for managing chronic complications like neuropathic pain and improving quality of life in diabetic patients.
- There is a need for better-designed studies to confirm the long-term benefits of WBV training in diabetic patients and to develop standardized protocols for its use.
Proposed Study:
- A planned study aims to investigate the immediate effects of WBV on balance, dual-task performance, and walking in individuals with type 2 diabetes and peripheral neuropathy. The study will include 40 patients who meet specific inclusion criteria, with participants randomized into two groups (WBV training group and control group).
- Data will be collected on participants' balance performance (using the Timed Up and Go test), dual-task performance (using a dual-task cost formula), and walking features (using the 1-minute walk test). The results will be analyzed using SPSS software.
Methodology:
- The study will use random assignment and include a control group to evaluate the immediate effects of WBV. Data collection will include assessments of balance, dual-task performance, and walking capabilities before and after WBV treatment.
Read the detailed description
Sure! Here's a more detailed and extended version of the summary:
Diabetes is a chronic health condition that can lead to various complications, affecting many aspects of human health. One of the significant complications resulting from diabetes is peripheral neuropathy, which is caused by hyperglycemia-induced damage to peripheral nerves. Over time, this condition results in axonal degeneration and demyelination, particularly affecting small unmyelinated fibers responsible for pain and temperature sensation, leading to sensory loss. In advanced stages, it can result in motor dysfunction, which particularly affects intrinsic foot muscles, leading to muscle weakness and atrophy. Peripheral neuropathy can significantly impair balance, dual-task performance, and gait, all of which are crucial for maintaining functional independence and mobility in diabetic patients.
The effect of Whole Body Vibration (WBV) training on these aspects has been an emerging research area. WBV, which uses mechanical vibrations produced by a vibrating platform to stimulate muscle contractions, has shown potential benefits in improving balance, dual-task performance, and gait in individuals with diabetic neuropathy. Several studies have suggested that WBV can serve as a complementary or superior alternative to traditional balance training exercises. For instance, a randomized controlled trial comparing WBV and Tai Chi in diabetic patients found that WBV was more effective than Tai Chi in promoting functional independence and improving balance.
In patients with diabetic peripheral neuropathy (DPN), sensory loss may prevent them from recognizing injuries, leading to severe complications. A study from 2017 explored the impact of WBV on vibration perception thresholds (VPT) in patients with type 2 diabetes and peripheral neuropathy, finding significant improvements in VPT, which indicated enhanced sensory function, critical for maintaining balance and gait. This improvement was attributed to increased blood circulation in peripheral tissues and better glucose control, which positively influenced sensory feedback mechanisms crucial for postural control.
Moreover, WBV has been shown to improve both static and dynamic balance in individuals with DPN, which is vital for reducing fall risks in these patients. The improvements in balance are believed to result from muscle contraction stimulation and the proprioceptive feedback provided by the vibrations. Furthermore, dual-task performance, which is often impaired in patients with DPN due to the difficulty of performing cognitive and motor tasks simultaneously, might also improve with WBV. This improvement could help patients perform better in daily activities that require multitasking, such as walking while engaging in cognitive tasks.
In the existing literature, there is evidence that WBV training enhances balance and walking ability in diabetic patients, although there is a gap in research that simultaneously addresses balance, dual-task performance, and gait parameters in type 2 diabetes patients. A systematic review conducted by Robinson and colleagues in 2018 noted the potential benefits of WBV in managing neuropathic pain and improving the quality of life for DPN patients, although the clinical effectiveness of WBV as an intervention for DPN remains unclear. This highlights the need for further research to clarify the therapeutic role of WBV in this patient population.
The growing body of evidence supporting the effectiveness of WBV in improving balance, dual-task performance, and gait in diabetic neuropathy patients suggests that it could be a promising therapeutic approach. The literature emphasizes the necessity for continued research to establish standardized protocols and further explore the physiological mechanisms underlying the potential benefits of WBV in this sensitive population. More well-designed studies are needed to confirm the long-term benefits of WBV training and validate its role in the management of diabetic neuropathy. By incorporating WBV into treatment programs, physiotherapists can provide a more holistic approach to managing diabetic neuropathy, enhancing functional outcomes and potentially improving the quality of life for affected individuals.
This study aims to provide a comprehensive overview of the immediate effects of WBV on balance, dual-task performance, and gait in individuals with diabetic neuropathy. The research will be conducted as a single-blind randomized controlled trial involving 40 participants diagnosed with diabetic peripheral neuropathy, all of whom will be selected voluntarily from a specialized diabetes foot clinic. Participants will be randomly assigned to either the experimental group (receiving WBV training) or the control group, with baseline and post-intervention assessments conducted to measure changes in balance, dual-task performance, and gait. Various tools, including the Timed Up and Go test, the Dual Task Costs formula, and the 1-minute walk test, will be used to assess these parameters. The study will utilize appropriate statistical analyses, including comparisons within and between groups, and will follow ethical guidelines, ensuring informed consent from all participants.
By evaluating these parameters, the study aims to contribute to the understanding of how WBV can improve functional outcomes in individuals with diabetic neuropathy and guide future therapeutic interventions.
- Being tested
- The Whole Body Vibration
- Keywords
- Diabetic Foot, Diabetes Mellitus, Foot Ulceration, Diabetic Neuropathy
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Foot Ulcer, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Whole Body VibrationDevice
Whole Body Vibration device may positively affect balance, dual-tasking and gait parameters by increasing the sensory input received under the sole in individuals diagnosed with diabetic foot. In individuals diagnosed with diabetic foot, the sensory/vibration perception threshold of individuals decreases due to the disease, so the balance of individuals is impaired. This may cause these individuals to experience gait disturbances in daily life. There are almost no studies in the literature on the use of whole body vibration for this patient group. This study will discuss the applicability of whole body vibration in the clinic for individuals diagnosed with diabetic foot and that it can be an additional adjunct to treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | In the Control Group, balance assessment with the Timed Up and Go Test, evaluation of dual task performance with the Dual Task Cost Gap Formula, and gait assessment with the 1 Minute Walk Test will be performed. |
| Whole Body Vibration Training Group | Experimental | For the Whole Body Vibration Training Group, balance, dual task performance and gait will be evaluated. These participants will be evaluated before and after 10 minutes of vibration application. Receives: Device: The Whole Body Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Performance
Change in balance performance assessed using the Timed Up and Go (TUG) test. The test measures the time taken (in seconds) to rise from a chair, walk 3 meters, turn, and return to sit. Lower times indicate better balance and functional mobility.
Measured: For the control group the test will be administered once at baseline and 10 minute later on the same day . In the vibration training group, it will be administered at Baseline (Before WBV) and Immediately After WBV (within 5 minutes).
Gait Performance
Change in walking capacity measured by the 1-Minute Walk Test. Total distance walked (in meters) is recorded, with greater distances indicating better walking endurance and gait function.
Measured: For the control group (one-time assessment at baseline and 10 minutes later), For the WBV Training Group Baseline (Pre-WBV) and Immediately Post-WBV
Secondary outcomes (3)
Functional Mobility (Timed Up and Go Test - TUG)
Change in functional mobility and dynamic balance measured by the Timed Up and Go (TUG) test. The outcome is the time taken (in seconds) to complete the test. A shorter time after WBV indicates improved mobility and balance.
Measured: Start (Before WBV) and Immediately After WBV (within 10 minutes)
Cognitive-Motor Performance (Dual-Task Timed Up and Go Test - DT-TUG)
Change in cognitive-motor performance measured by the Dual-Task Timed Up and Go (DT-TUG) test. Performance is evaluated through the dual-task gap formula, reflecting the percentage increase in TUG time during the cognitive task. A reduced dual-task gap post-WBV suggests better cognitive-motor integration.
Measured: Start (Before WBV) and Immediately After WBV (within 5 minutes)
Walking Capacity (1-Minute Walk Test)
Change in walking distance measured by the 1-Minute Walk Test. The total distance walked (in meters) reflects gait capacity, endurance, and speed. An increased distance after WBV indicates enhanced walking performance.
Measured: Start (Before WBV) and Immediately After WBV (within 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start20 Apr 2025 (estimated)
- Primary completion20 Feb 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetus MellitusStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows an interventional pre-post experimental design, focusing on the immediate effects of whole-body vibration (WBV) on balance, gait, and dual-task performance in patients with diabetic foot. The interventional model used is a single-group pretest-posttest design, where participants undergo a single WBV session, and their performance metrics are assessed before and after the intervention.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulhane Training and Research Hospital, Gulhane School of Medicine
- Responsible party
- Principal investigator, Tezel Yıldırım Şahan, Hacettepe University
- Investigators
- Tezel Şahan, Study director, Gülhane Sağlık Bilimleri ÜniversitesiDilek N Kara, Principal investigator, Bağlı OlmayanKerim B Profesör Doktor, Study chair, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878651
- Sponsor's protocol ID
- 2024-553
- Status last verified
- Mar 2025
- First submitted
- 21 Feb 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is a clause in our consent form about the use of the information for other studies. This is something that is emphasized by our university. Therefore, in order to protect patient rights, it is not possible to share information without patient consent.
Publications
Sohrabzadeh E, Kalantari KK, Naimi SS, Daryabor A, Akbari NJ. The immediate effect of a single whole-body vibration session on balance, skin sensation, and pain in patients with type 2 diabetic neuropathy. J Diabetes Metab Disord. 2021 Nov 25;21(1):43-49. doi: 10.1007/s40200-021-00933-w. eCollection 2022 Jun.
PubMed 35673453Jamal A, Ahmad I, Ahamed N, Azharuddin M, Alam F, Hussain ME. Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. J Diabetes Metab Disord. 2019 Dec 21;19(1):61-69. doi: 10.1007/s40200-019-00476-1. eCollection 2020 Jun.
PubMed 32550157
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Immediate Effects of Whole Body Vibration Training on Balance, Dual Task and Gait in Individuals with Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT06878651
- Acronym / sponsor ID
- 2024-553
- Keywords
- Diabetic Foot, Diabetes Mellitus, Foot Ulceration, Diabetic Neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Gulhane Training and Research Hospital, Gulhane School of Medicine
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 17 Mar 2025 (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.
Overview of Diabetes and Its Complications:
- Diabetes is a chronic health issue that can lead to various complications, affecting human health negatively. One of these complications is diabetic peripheral neuropathy (DPN), which results from hyperglycemia and affects peripheral nerves. This can lead to sensory loss, motor dysfunction, and ultimately, disability.
- The complications from diabetes can result in the loss of function and disability, affecting various systems, including the nervous system (e.g., retinopathy, neuropathy, and atherosclerosis).
Peripheral Neuropathy in Diabetes:
- DPN occurs due to damage to peripheral nerves caused by hyperglycemia. Over time, it affects the small unmyelinated fibers responsible for pain and temperature sensations, leading to axonal degeneration and demyelination, causing sensory loss.
- In later stages, motor dysfunction can also occur, impacting intrinsic foot muscles, leading to muscle weakness and atrophy.
Whole Body Vibration (WBV) Therapy:
- WBV is a therapeutic method that uses mechanical vibrations from a vibrating platform to stimulate muscle contractions. It is being researched for its effects on managing diabetic neuropathy and related complications.
- Studies have shown that WBV can improve balance, functional independence, and postural stability in patients with diabetes, potentially serving as an alternative or complement to traditional balance exercises.
- A randomized controlled trial compared the effects of WBV and Tai Chi on postural balance and found that WBV was more effective in promoting functional independence and balance.
Impact on Sensory Function and Balance:
- As DPN progresses, sensory loss may prevent patients from noticing injuries, which could lead to severe complications. A study conducted in 2017 showed that WBV improved vibration perception thresholds (VPT) in patients with type 2 diabetes and peripheral neuropathy, indicating improved sensory function, which is crucial for maintaining balance and walking.
- This improvement is thought to be linked to increased blood circulation in peripheral tissues and improved glucose levels due to WBV therapy.
Dual Task Performance and WBV:
- Dual-task performance, which involves performing cognitive and motor tasks simultaneously, is typically impaired in patients with diabetic neuropathy, leading to difficulties in daily activities. WBV has shown potential in improving muscle strength and balance, which could enhance patients' ability to perform dual tasks more effectively.
Research Findings:
- Several studies have demonstrated that WBV training can significantly improve both static and dynamic balance in patients with diabetic neuropathy. Given that balance issues are common in these patients and contribute to a higher risk of falls, these improvements are particularly important.
- The literature emphasizes the need for continued research to clarify the physiological mechanisms behind WBV's effects on sensory feedback mechanisms, which are essential for postural control.
Need for Further Research:
- Despite promising findings, some studies have pointed out the need for more research to validate the clinical efficacy of WBV for managing chronic complications like neuropathic pain and improving quality of life in diabetic patients.
- There is a need for better-designed studies to confirm the long-term benefits of WBV training in diabetic patients and to develop standardized protocols for its use.
Proposed Study:
- A planned study aims to investigate the immediate effects of WBV on balance, dual-task performance, and walking in individuals with type 2 diabetes and peripheral neuropathy. The study will include 40 patients who meet specific inclusion criteria, with participants randomized into two groups (WBV training group and control group).
- Data will be collected on participants' balance performance (using the Timed Up and Go test), dual-task performance (using a dual-task cost formula), and walking features (using the 1-minute walk test). The results will be analyzed using SPSS software.
Methodology:
- The study will use random assignment and include a control group to evaluate the immediate effects of WBV. Data collection will include assessments of balance, dual-task performance, and walking capabilities before and after WBV treatment.
Detailed description
Sure! Here's a more detailed and extended version of the summary:
Diabetes is a chronic health condition that can lead to various complications, affecting many aspects of human health. One of the significant complications resulting from diabetes is peripheral neuropathy, which is caused by hyperglycemia-induced damage to peripheral nerves. Over time, this condition results in axonal degeneration and demyelination, particularly affecting small unmyelinated fibers responsible for pain and temperature sensation, leading to sensory loss. In advanced stages, it can result in motor dysfunction, which particularly affects intrinsic foot muscles, leading to muscle weakness and atrophy. Peripheral neuropathy can significantly impair balance, dual-task performance, and gait, all of which are crucial for maintaining functional independence and mobility in diabetic patients.
The effect of Whole Body Vibration (WBV) training on these aspects has been an emerging research area. WBV, which uses mechanical vibrations produced by a vibrating platform to stimulate muscle contractions, has shown potential benefits in improving balance, dual-task performance, and gait in individuals with diabetic neuropathy. Several studies have suggested that WBV can serve as a complementary or superior alternative to traditional balance training exercises. For instance, a randomized controlled trial comparing WBV and Tai Chi in diabetic patients found that WBV was more effective than Tai Chi in promoting functional independence and improving balance.
In patients with diabetic peripheral neuropathy (DPN), sensory loss may prevent them from recognizing injuries, leading to severe complications. A study from 2017 explored the impact of WBV on vibration perception thresholds (VPT) in patients with type 2 diabetes and peripheral neuropathy, finding significant improvements in VPT, which indicated enhanced sensory function, critical for maintaining balance and gait. This improvement was attributed to increased blood circulation in peripheral tissues and better glucose control, which positively influenced sensory feedback mechanisms crucial for postural control.
Moreover, WBV has been shown to improve both static and dynamic balance in individuals with DPN, which is vital for reducing fall risks in these patients. The improvements in balance are believed to result from muscle contraction stimulation and the proprioceptive feedback provided by the vibrations. Furthermore, dual-task performance, which is often impaired in patients with DPN due to the difficulty of performing cognitive and motor tasks simultaneously, might also improve with WBV. This improvement could help patients perform better in daily activities that require multitasking, such as walking while engaging in cognitive tasks.
In the existing literature, there is evidence that WBV training enhances balance and walking ability in diabetic patients, although there is a gap in research that simultaneously addresses balance, dual-task performance, and gait parameters in type 2 diabetes patients. A systematic review conducted by Robinson and colleagues in 2018 noted the potential benefits of WBV in managing neuropathic pain and improving the quality of life for DPN patients, although the clinical effectiveness of WBV as an intervention for DPN remains unclear. This highlights the need for further research to clarify the therapeutic role of WBV in this patient population.
The growing body of evidence supporting the effectiveness of WBV in improving balance, dual-task performance, and gait in diabetic neuropathy patients suggests that it could be a promising therapeutic approach. The literature emphasizes the necessity for continued research to establish standardized protocols and further explore the physiological mechanisms underlying the potential benefits of WBV in this sensitive population. More well-designed studies are needed to confirm the long-term benefits of WBV training and validate its role in the management of diabetic neuropathy. By incorporating WBV into treatment programs, physiotherapists can provide a more holistic approach to managing diabetic neuropathy, enhancing functional outcomes and potentially improving the quality of life for affected individuals.
This study aims to provide a comprehensive overview of the immediate effects of WBV on balance, dual-task performance, and gait in individuals with diabetic neuropathy. The research will be conducted as a single-blind randomized controlled trial involving 40 participants diagnosed with diabetic peripheral neuropathy, all of whom will be selected voluntarily from a specialized diabetes foot clinic. Participants will be randomly assigned to either the experimental group (receiving WBV training) or the control group, with baseline and post-intervention assessments conducted to measure changes in balance, dual-task performance, and gait. Various tools, including the Timed Up and Go test, the Dual Task Costs formula, and the 1-minute walk test, will be used to assess these parameters. The study will utilize appropriate statistical analyses, including comparisons within and between groups, and will follow ethical guidelines, ensuring informed consent from all participants.
By evaluating these parameters, the study aims to contribute to the understanding of how WBV can improve functional outcomes in individuals with diabetic neuropathy and guide future therapeutic interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study follows an interventional pre-post experimental design, focusing on the immediate effects of whole-body vibration (WBV) on balance, gait, and dual-task performance in patients with diabetic foot. The interventional model used is a single-group pretest-posttest design, where participants undergo a single WBV session, and their performance metrics are assessed before and after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –In the Control Group, balance assessment with the Timed Up and Go Test, evaluation of dual task performance with the Dual Task Cost Gap Formula, and gait assessment with the 1 Minute Walk Test will be performed. |
| Whole Body Vibration Training Group | Experimental | Device: The Whole Body VibrationFor the Whole Body Vibration Training Group, balance, dual task performance and gait will be evaluated. These participants will be evaluated before and after 10 minutes of vibration application. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes patients aged 40-75 years,
- Having a score of 13-29 on the Michigan Questionnaire (intermediate level),
- Having a Mini Mental Test score of 24 and above,
- Having an HbA1C <8.5%, having controlled blood glucose levels in the last three months,
- Being able to walk independently
Key exclusion criteria (6 listed)
- Those with diabetic infected wounds,
- Those with neurological diseases other than diabetic neuropathy,
- Those with rheumatoid arthritis, vestibular system disorders, visual
- Impairments, those with a history of trauma, injury and surgery,
- Those with knee or hip replacement,
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 |
|---|---|---|
| The Whole Body VibrationWhole Body Vibration device may positively affect balance, dual-tasking and gait parameters by increasing the sensory input received under the sole in individuals diagnosed with diabetic foot. In individuals diagnosed with diabetic foot, the sensory/vibration perception threshold of individuals decreases due to the disease, so the balance of individuals is impaired. This may cause these individuals to experience gait disturbances in daily life. There are almost no studies in the literature on the use of whole body vibration for this patient group. This study will discuss the applicability of whole body vibration in the clinic for individuals diagnosed with diabetic foot and that it can be an additional adjunct to treatment. | Device | Whole Body Vibration Training Group |
Primary outcome
Balance Performance
Time frame: For the control group the test will be administered once at baseline and 10 minute later on the same day . In the vibration training group, it will be administered at Baseline (Before WBV) and Immediately After WBV (within 5 minutes).
Change in balance performance assessed using the Timed Up and Go (TUG) test. The test measures the time taken (in seconds) to rise from a chair, walk 3 meters, turn, and return to sit. Lower times indicate better balance and functional mobility.
Gait Performance
Time frame: For the control group (one-time assessment at baseline and 10 minutes later), For the WBV Training Group Baseline (Pre-WBV) and Immediately Post-WBV
Change in walking capacity measured by the 1-Minute Walk Test. Total distance walked (in meters) is recorded, with greater distances indicating better walking endurance and gait function.
3 secondary outcomes
Functional Mobility (Timed Up and Go Test - TUG)
Time frame: Start (Before WBV) and Immediately After WBV (within 10 minutes)
Cognitive-Motor Performance (Dual-Task Timed Up and Go Test - DT-TUG)
Time frame: Start (Before WBV) and Immediately After WBV (within 5 minutes)
Walking Capacity (1-Minute Walk Test)
Time frame: Start (Before WBV) and Immediately After WBV (within 5 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Background: PubMed 35673453Sohrabzadeh E, Kalantari KK, Naimi SS, Daryabor A, Akbari NJ. The immediate effect of a single whole-body vibration session on balance, skin sensation, and pain in patients with type 2 diabetic neuropathy. J Diabetes Metab Disord. 2021 Nov 25;21(1):43-49. doi: 10.1007/s40200-021-00933-w. eCollection 2022 Jun.
- Background: PubMed 32550157Jamal A, Ahmad I, Ahamed N, Azharuddin M, Alam F, Hussain ME. Whole body vibration showed beneficial effect on pain, balance measures and quality of life in painful diabetic peripheral neuropathy: a randomized controlled trial. J Diabetes Metab Disord. 2019 Dec 21;19(1):61-69. doi: 10.1007/s40200-019-00476-1. eCollection 2020 Jun.
- Individual participant dataSharing planned: No. There is a clause in our consent form about the use of the information for other studies. This is something that is emphasized by our university. Therefore, in order to protect patient rights, it is not possible to share information without patient consent.
Related trials for Diabetus Mellitus
Not yet recruitingObservational study
Central Sensitization in Painful and Painless Diabetic Peripheral Neuropathy
Diabetes Mellitus (DM)
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.
Tezel Şahan study director
Gülhane Sağlık Bilimleri Üniversitesi
Dilek N Kara principal investigator
Bağlı Olmayan
Kerim B Profesör Doktor study chair
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Whole Body Vibration in people with Diabetus Mellitus and Diabetic Foot Ulcer, run by Hacettepe University 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 17 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tezel Şahan (+90 ext. 5056615279, tezelyildirim.sahan@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Performance (time frame: For the control group the test will be administered once at baseline and 10 minute later on the same day . In the vibration training group, it will be administered at Baseline (Before WBV) and Immediately After WBV (within 5 minutes).). The study lists 2 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 NCT06878651, which also lists 2 linked publications.
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 17 Mar 2025.