Effect of Transcranial Direct Current Stimulation on Sensory Integration

Diabetic Polyneuropathy Clinical Trial

Official title:

Effect of Transcranial Direct Current Stimulation on Sensory Integration and Risk of Falling in Diabetic Polyneuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04516200
• Other study ID #: P.T.REC/012/002000
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2020
• Est. completion date: October 2020

Study information

• Verified date: August 2020
• Source: MTI University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Polyneuropathies

Intervention

Device:
• transcranial direct current stimulation and traditional physical therapy program
Transcranial stimulation will be applied only for the study group.

Other:
• designed physical therapy program
sensory training and balance training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MTI University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sway index of sensory integration test	sway index of sensory integration test will be measured by biodex balance system	two months
Secondary	risk of fall index	risk of fall index will be measured by biodex balance system	two months