Effect of Transcranial Direct Current Stimulation on Sensory Integration

NCT04516200 | Unknown

• 1 other identifier: P.T.REC/012/002000
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Polyneuropathy

Outcome Measures

Primary Outcomes (1)

• sway index of sensory integration test

  sway index of sensory integration test will be measured by biodex balance system

  two months

Secondary Outcomes (1)

• risk of fall index

  two months

Study Arms (2)

Transcranial direct current stimulation

EXPERIMENTAL

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.

Device: transcranial direct current stimulation and traditional physical therapy program; Other: designed physical therapy program

traditional physical therapy program

PLACEBO COMPARATOR

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

Other: designed physical therapy program

Interventions

transcranial direct current stimulation and traditional physical therapy program DEVICE

Transcranial stimulation will be applied only for the study group.

Also known as: Gymna- uniphy(phy-action 787)

Transcranial direct current stimulation

designed physical therapy program OTHER

sensory training and balance training

Transcranial direct current stimulation; traditional physical therapy program

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient will be diagnosed as having Diabetic Polyneuropathy (DPN) and all patients have type II diabetes.
• The age of the patients ranged from 35 to 55 years.
• Clinically all patients suffered from glove stock hyposthesia, numbness and burning sensation and mild distal moror weakness
• Patients have sensorymotor peripheral neuropathy according to neurophysiological study to detect sensory and motor conduction velocity to confirm diagnosis.

You may not qualify if:

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

Sponsors & Collaborators

• MTI University: lead

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Group 1: transcranial direct current stimulation and traditional physical therapy program Group 2: the same traditional physical therapy program

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: August 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 20, 2020

Record last verified: 2020-08