Clinical trial NCT04516200: Effect of Transcranial Direct Current Stimulation on Sensory Integration
Official title: Effect of Transcranial Direct Current Stimulation on Sensory Integration and Risk of Falling in Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Polyneuropathy
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2020-08-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: transcranial direct current stimulation and traditional physical therapy program Group 2: the same traditional physical therapy program
Primary purpose: TREATMENT

Brief summary: To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.

Detailed description: PURPOSE:

To determine the effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy.

BACKGROUND:

Diabetic polyneuropathy is the most prevalent chronic complication affecting 30% - 50% of diabetic patients. Diabetic polyneuropathy usually affect the peripheral, autonomic, and central nervous systems with several clinical symptoms .About 80% of the cases of DN manifest as distal symmetrical sensorimotor polyneuropathy which is responsible for cases of chronic pain; impaired sleep quality; increase of the falling risk associated with weakness and increase of the risk of extremities amputation. Transcranial direct current stimulation is neurophysiologic intervention that alters cortical excitability to enhance lower extremity somato-sensation and thus improve functional outcomes.

HYPOTHESES:

There will be no effect of Transcranial direct current stimulation on sensory integration and risk of falling in diabetic polyneuropathy

Eligibility criteria: Inclusion Criteria:

1 - Patient will be diagnosed as having Diabetic Polyneuropathy (DPN) and all patients have type II diabetes.

2-The age of the patients ranged from 35 to 55 years.

3-Clinically all patients suffered from glove stock hyposthesia, numbness and burning sensation and mild distal moror weakness

4-Patients have sensorymotor peripheral neuropathy according to neurophysiological study to detect sensory and motor conduction velocity to confirm diagnosis.

Exclusion Criteria:

1. History of diabetic ulcer and amputation .
2. Osteoporosis.
3. Fractures of lower limbs.
4. Gross musculoskeletal problems eg:burn.
5. Significant Scar tissue or calluses on the feet.
6. Peripheral vascular diseases (PVD) or Microcirculation problems.
7. Balance disturbance rather than diabetic peripheral neuropathy as ear problems, labrynthinitis, stroke or cerebellar problems.
8. Visual disturbance.
9. Autonomic neuropathy.
10. Advanced Osteoarthritis of lower limbs.
11. Nerve root compression (Radicuolopathy) affecting lower limbs.
12. Patients with implanted devices for pain control such as deep brain

Primary outcomes:
measure: sway index of sensory integration test
timeFrame: two months
Secondary outcomes:
measure: risk of fall index
timeFrame: two months
Other outcomes:
Locations:
Study officials:
References: