Effect of High Tone Power Therapy on Neurophysiological Measures and Function Outcome in Patients With Diabetic Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- October 6 University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Measuring Nerve Conduction Velocity
Study Overview
Brief Summary
The purpose of the study is to investigate the effect of high tone power therapy on neurophysiological measures and function outcome in patients with diabetic neuropathy.
Detailed Description
Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose (or blood sugar), which leads over time to serious damage to the heart, blood vessels, eyes, kidneys, and nerves. The most common is type 2 diabetes, usually in adults, which occurs when the body becomes resistant to insulin or doesn't make enough insulin.
Diabetic neuropathies (DNs) are nerve damaging disorders associated with diabetes mellitus. These conditions are thought to result from diabetic microvascular injury involving small blood vessels that supply nerves (vasa nervorum) in addition to macrovascular conditions that can culminate in diabetic neuropathy.
The most common characteristics of diabetic neuropathy (DN) are a distal, symmetrical, primarily sensory polyneuropathy affecting the feet and legs in a chronic, slowly progressive manner. The incidence and prevalence of DN associated with duration of diabetes affect up to 50% of diabetic patients. Although DN is known as the most common complications of diabetes. Diabetic neuropathy is estimated that 40% to 50% of people with diabetes will have DN within 10 years of diagnosis.
High tone power therapy (Hi Top) is the percutaneous electrical stimulation of skeletal muscles using alternative frequencies between 4.096 and 32.768 hertz to produce a muscle contraction and the treatment of diabetic neuropathy. The therapy frequency is scanned with a defined frequency. This method is called SimulFAM for Simultaneous Frequency Amplitude Modulation.
High tone power therapy (Hi Top) is a new quantum leap in the field of electro therapy. It is Electrotherapy with sinusoidal alternating currents. The high tone power therapy provides a therapy with medium frequency sine waves. The therapy is free of direct current (D.C.) components. The amplitude and the frequency are modulated simultaneously. The higher the frequency, the more energy can be introduced corresponding to the individual threshold curve of the patient's electrosensitivity.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Forty type II referred diabetic neuropathy patients from both genders their ages will be ranged from 40-60 years old.
- •All patients with diabetic neuropathy > 10 years having diabetes (will be examined according to the general and specific neurological evaluation sheet for diabetic neuropathy).
- •All patients in the study should be ambulant independently.
- •All patients should be medically stable.
- •The body mass index (BMI) ranged from 20:30 Kg/m
- •All patients will approve and sign a consent form.
Exclusion Criteria
- •Patients < 10 years having diabetes.
- •Patients with musculoskeletal deformities and disorders.
- •Patients with psychiatric disorders or seizures.
- •Patients with visual and auditory impairment or tremors influencing balance.
- •Patients with other neuromuscular disorders.
- •Patients with BMI more than 30 kg/m
- •Patients with foot deformities and ulcers.
- •Patients with cognitive impairment using mini-mental state examination (MMSE).
- •Patients with lower limb operations.
Arms & Interventions
Group I
Group I (Study): will consist of 20 patients with diabetic neuropathy and will receive High tone power therapy in addition to selected physical therapy program (Wobble board training, AROM exercises for both UL & LL, gentle manual stretching exercises for both UL & LL and graduated gait training). for 10 sessions every other day, each session for 1.45 hours (60 minutes for HiTop and 45 minutes for selected physical therapy program).
Intervention: High tone power therapy (Device)
Group I
Group I (Study): will consist of 20 patients with diabetic neuropathy and will receive High tone power therapy in addition to selected physical therapy program (Wobble board training, AROM exercises for both UL & LL, gentle manual stretching exercises for both UL & LL and graduated gait training). for 10 sessions every other day, each session for 1.45 hours (60 minutes for HiTop and 45 minutes for selected physical therapy program).
Intervention: Selected Physical Therapy Program (Other)
Group II
Group II (Control): will consist of 20 patients with diabetic neuropathy and will receive selected physical therapy program only same as group I. For 10 sessions every other day, each session for 45 minutes.
Intervention: Selected Physical Therapy Program (Other)
Outcomes
Primary Outcomes
Measuring Nerve Conduction Velocity
Time Frame: Up to 30 days
Neuro pack M1 EP/EMG measuring system MEB-9200/9300
Secondary Outcomes
No secondary outcomes reported
Investigators
Ahmed Magdy Alshimy
Assistant Lecturer in Neurological Physical Therapy
October 6 University