Clinical trial NCT05190198: Effect of Ankle Proprioception Training in Type 2 Diabetic Neuropathy
Official title: Effect of Ankle Proprioception Training in Improving the Balance in Patients of Type 2 Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Proprioception can help with joint stability, postural control, and many other conscious sensations. The diabetes mellitus patients showed a decrease in the reflex responses to postural disturbance followed by a decrease in the speed of nerve conduction which leads to disturbance of the balance and increases the risk of falls.The hip and ankle joints play important roles in the control of balance.The major functions of the ankle joint are control of balance against postural disturbances, shock absorption during walking, and movement of the lower limbs. To provide these, it is necessary to maintain a sufficient range of motion of the ankle joint, muscle strength, and proprioceptive sense.

A study reported that both proprioception exercise training and backward walking training are effective in increasing the proprioception sensation of lower limbs. However, proprioception exercise training was better than backward walking training in improving the feeling of proprioception in the lower limbs of patients with diabetic neuropathy. a study was conducted to investigate the effectiveness of an ankle proprioceptive control program on the gait of patients with chronic stroke. The study results provide evidence to support the effectiveness of an ankle proprioceptive control program in improving gait ability of patients with chronic stroke. A study reported that the addition of ankle proprioceptive training to traditional physical therapy exercises could provide more improvement of gait ability and decrease the risk of falling in patients with diabetic neuropathy.

Proper evidence behind ankle proprioception training in the improvement of balance in diabetic neuropathy patients is sparse and is based on different clinical experiences and fewer studies with limited methodological design. Despite the strong relationship between ankle proprioception and gait ability which has been reported in the previous research studies, up till now, there is no study to assess to what extent ankle proprioceptive training can improve balance in patients with diabetic neuropathy. So, the current study will investigate the effects of ankle proprioceptive training in improving the balance in patients with diabetic neuropathy.

Eligibility criteria: 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.

Primary outcomes:
measure: Fall Efficiency Scale-International (FES-I)
timeFrame: week 8
measure: Timed up and go test (TUG)
timeFrame: week 8
measure: Berg Balance Scale
timeFrame: week 8
measure: Modified Toronto Clinical Neuropathy Score (mTCNS)
timeFrame: week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Kallar Kahar
country: Pakistan
facility: Maryam Day Care Clinic Kallar Kahar
Study officials:
affiliation: Riphah International University
name: Ayesha Afridi, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Jeannin AC, Salem JE, Massy Z, Aubert CE, Vermeer C, Amouyal C, Phan F, Halbron M, Funck-Brentano C, Hartemann A, Bourron O. Inactive matrix gla protein plasma levels are associated with peripheral neuropathy in Type 2 diabetes. PLoS One. 2020 Feb 24;15(2):e0229145. doi: 10.1371/journal.pone.0229145. eCollection 2020.