Effect of Ankle Proprioception Training in Type 2 Diabetic Neuropathy

Not Applicable

Completed

• Conditions: Diabetic Neuropathies
• Interventions: Other: Proprioceptive neuromuscular facilitation; Other: conventional therapy

• Registration Number: NCT05190198
• Lead Sponsor: Riphah International University

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.

Study Timeline

• Study First Submitted: 2021-12-29
• Study First Submitted QC: 2021-12-29
• Study First Posted: 2022-01-13
• Study Start: 2022-01-15
• Primary Completion: 2022-07-27
• Study Completion: 2022-07-27
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-17
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Proprioceptive neuromuscular facilitation	The experimental group will receive ankle proprioceptive training. Ankle proprioceptive training includes the following group of exercises: 1. Training on the floor for 10 minutes (1-8 weeks) 2. Training on balance pad for 10 minutes (1-4 weeks) 3. Training on rocked balance board for 10 minutes (5-8 week)
Conventional therapy group	conventional therapy	The control group will receive Traditional physical therapy exercises. 1. Active range of motion exercises for ankle and subtalar joints for 5 minutes. 2. Functional balance training for 15 minutes involving 3. Gait training for 10 minutes.

Primary Outcome Measures

Name	Time	Method
Fall Efficiency Scale-International (FES-I)	week 8	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.
Timed up and go test (TUG)	week 8	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
Berg Balance Scale	week 8	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.
Modified Toronto Clinical Neuropathy Score (mTCNS)	week 8	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.

Trial Locations

Locations (1)

Maryam Day Care Clinic Kallar Kahar; 🇵🇰 Kallar Kahar, Pakistan