Effect of Transcranial Direct Current Stimulation on Sensory Integration

NCT ID: NCT04516200

Last Updated: 2020-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2020-10-31

Brief Summary

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

Detailed Description

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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

Conditions

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Diabetic Polyneuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: transcranial direct current stimulation and traditional physical therapy program Group 2: the same traditional physical therapy program
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
single blind masking

Study Groups

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Transcranial direct current stimulation

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.

Group Type EXPERIMENTAL

transcranial direct current stimulation and traditional physical therapy program

Intervention Type DEVICE

Transcranial stimulation will be applied only for the study group.

designed physical therapy program

Intervention Type OTHER

sensory training and balance training

traditional 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

Group Type PLACEBO_COMPARATOR

designed physical therapy program

Intervention Type OTHER

sensory training and balance training

Interventions

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transcranial direct current stimulation and traditional physical therapy program

Transcranial stimulation will be applied only for the study group.

Intervention Type DEVICE

designed physical therapy program

sensory training and balance training

Intervention Type OTHER

Other Intervention Names

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Gymna- uniphy(phy-action 787)

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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MTI University

OTHER

Sponsor Role lead

Responsible Party

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Sara Salah El-Din Abdel Megeed

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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P.T.REC/012/002000

Identifier Type: -

Identifier Source: org_study_id

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