The Instant Effect of Whole Body Vibration in Diabetics

Condition(s) studied

Investigational drug(s) / intervention(s)

The Whole Body Vibration: 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 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. 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.

Eligibility

Primary outcome measure(s)

• Balance Performance — 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 — 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.

Trial sites (1)

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