Back to resultsEffect of Transcranial Direct Current Stimulation on Sensory Integration
Primary Purpose
Diabetic Polyneuropathy
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcranial direct current stimulation and traditional physical therapy program
designed physical therapy program
Sponsored by
About this trial
This is an interventional treatment trial for 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:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Transcranial direct current stimulation
traditional physical therapy program
Arm Description
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 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
Outcomes
Primary Outcome Measures
sway index of sensory integration test
sway index of sensory integration test will be measured by biodex balance system
Secondary Outcome Measures
risk of fall index
risk of fall index will be measured by biodex balance system
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04516200
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MTI University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Group 1: transcranial direct current stimulation and traditional physical therapy program Group 2: the same traditional physical therapy program
Masking
Participant
Masking Description
single blind masking
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcranial direct current stimulation
Arm Type
Experimental
Arm Description
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.
Arm Title
traditional physical therapy program
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation and traditional physical therapy program
Other Intervention Name(s)
Gymna- uniphy(phy-action 787)
Intervention Description
Transcranial stimulation will be applied only for the study group.
Intervention Type
Other
Intervention Name(s)
designed physical therapy program
Intervention Description
sensory training and balance training
Primary Outcome Measure Information:
Title
sway index of sensory integration test
Description
sway index of sensory integration test will be measured by biodex balance system
Time Frame
two months
Secondary Outcome Measure Information:
Title
risk of fall index
Description
risk of fall index will be measured by biodex balance system
Time Frame
two months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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:
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
12. IPD Sharing Statement
Learn more about this trial
Effect of Transcranial Direct Current Stimulation on Sensory Integration
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