Effect of Transcranial Direct Current Stimulation on Sensory Integration

Not Applicable

• Conditions: Diabetic Polyneuropathy
• Interventions: Device: transcranial direct current stimulation and traditional physical therapy program; Other: designed physical therapy program

• Registration Number: NCT04516200
• Lead Sponsor: MTI University

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

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08
• Primary Completion: 2020-08
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-18
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-20
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcranial direct current stimulation	transcranial direct current stimulation and traditional physical therapy program	Transcranial direct current stimulation will be applied to study group only . Anodal transcranial stimulation will be applied on left somatosensory cortex while the cathodal one will be applied on right supra-orbital area with frequency of 2m.A for 20 minutes.Stimulation will be applied three times per week for two months.
traditional physical therapy program	designed physical therapy program	traditional physical therapy program will be applied to both the control group and study group. It will be consist of sensory re-education training and balance training.Exercises will be applied three times per week for two months
Transcranial direct current stimulation	designed physical therapy program	Transcranial direct current stimulation will be applied to study group only . Anodal transcranial stimulation will be applied on left somatosensory cortex while the cathodal one will be applied on right supra-orbital area with frequency of 2m.A for 20 minutes.Stimulation will be applied three times per week for two months.

Primary Outcome Measures

Name	Time	Method
sway index of sensory integration test	two months	sway index of sensory integration test will be measured by biodex balance system

Secondary Outcome Measures

Name	Time	Method
risk of fall index	two months	risk of fall index will be measured by biodex balance system