Diabetic Neuropathies Clinical Trial
Official title:
Effect of Ankle Proprioception Training in Improving the Balance in Patients of Type 2 Diabetic Neuropathy
Verified date | September 2022 |
Source | Riphah International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Diabetes mellitus is a metabolic disease described by hyperglycemia, which results from deficiencies in insulin secretion, the action of insulin on the target tissue, both. Chronic hyperglycemia can lead to long-standing damage and failure of various organs, including the kidneys, heart, eyes, blood vessels, and nerves. Diabetes mellitus is one of the world's biggest public health problems, affecting about 415 million people worldwide among adults aged 20 to 79 years. Patients with type 2 diabetic neuropathy (DN) are at increased risk of falls. This increased risk is likely because of the well-documented balance problems attributed to neuropathy and sensory ataxia, which is the lack of precise proprioceptive feedback. Sources of instability in patients with type 2 DN include loss or reduction of peripheral sensory information in the feet, the inability of the central nervous system (CNS) to appropriately integrate the available postural control information, and the shift from an ankle-based method to a hip-based balance strategy. In addition, increased use of vestibular information and reliance on visual information alter the style of postural control in patients with diabetic neuropathy. Individuals with diabetic peripheral neuropathy (DPN) are 15 times more likely to experience falls compared to healthy subjects.
Status | Completed |
Enrollment | 46 |
Est. completion date | July 27, 2022 |
Est. primary completion date | July 27, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients having peripheral neuropathy previously diagnosed by physician / Modified Toronto Clinical Neuropathy Score 9-11 = moderate neuropathy; = 12 = severe neuropathy - Type II diabetes mellitus - Timed up and go test <20 sec - Berg Balance score between 20-40 - Able to walk without assistance or assistive device - controlled blood glucose level Exclusion Criteria: - Cognitive Deficits - Severe retinopathy - Severe nephropathy that causes edema or needs hemodialysis. - Scars under their feet - Other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, or severe osteoarthritis) - Any medical conditions that would confound the assessment of neuropathy, such as malignancy, active/untreated thyroid disease. |
Country | Name | City | State |
---|---|---|---|
Pakistan | Maryam Day Care Clinic Kallar Kahar | Kallar Kahar |
Lead Sponsor | Collaborator |
---|---|
Riphah International University |
Pakistan,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fall Efficiency Scale-International (FES-I) | Risk of falling is assessed with Fall Efficiency Scale- International (FES-I). This is a self-reported 16-item scale of perceived confidence to complete physical daily activities. It scored each item on a four-point scale (1 = not at all concerned, 2 = somewhat concerned, 3 = fairly concerned and 4 = very concerned). The possible total score is 64 in the worst case and 16 in the best condition to do all tasks with no concern of falling. | week 8 | |
Primary | Timed up and go test (TUG) | The Timed Up and Go (TUG) is a screening tool used to test basic mobility skills of frail elderly patients (60-90 years old). They can use the TUG with but is not limited to, persons with stroke. 10s Completely independent With or without walking aid for ambulation and transfers < 20s Independent for main transfers With or without walking aid, independent for basic tub or shower transfers and able to climb most stairs and go outside alone > 30s Requires assistance dependent in most activities |
week 8 | |
Primary | Berg Balance Scale | The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item comprising a five-point ordinal scale ranging from 0 to 4, with 0 showing the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. | week 8 | |
Primary | Modified Toronto Clinical Neuropathy Score (mTCNS) | It is a screening tool for diabetic peripheral neuropathy and correlates with the severity of diabetic neuropathy. The mTCNS comprises two sub-scores only: symptom score and sensory test score. The values of the symptoms score range between 0 and 18 points. | week 8 |
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