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Completed

NCT Number: NCT05190198

Effect of Ankle Proprioception Training in Type 2 Diabetic Neuropathy

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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maryam Day Care Clinic Kallar Kahar

Kallar Kahar, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proprioceptive Neuromuscular facilitation

Other
  • Weight shifting in each direction (anteriorly, posteriorly, and lateral side) combined with side-to-side head movements (5 times for each direction).
  • One-legged stance with slight knee flexion of another leg for 15 seconds (5 times for each leg).
  • One-legged stance with increasing knee flexion of the other leg for 15 seconds (5 times for each leg).
  • Standing on a balance pad with shifting weight (anteriorly, posteriorly, and lateral side) 10 times in each direction.
  • In standing position, moving the weight left and right maximally.
  • In standing position, moving the weight forward and backward maximally.
  • In standing position, moving both heels of feet up and down.
  • In standing position, bending and stretching both knees by squatting as much as possible.

Conventional Therapy

Other

(Dorsiflexion, planter flexion, eversion and inversion) 10 repetitions for each movement.

(A) Sit to stand (5 times). (B) Standing with shifting Weight anteriorly, posteriorly, and sideway (5 times for each direction). (C) Functional reach sideway and anterior for touching targets set by the therapist (5 times for each direction). (D) Standing on heels for 20 seconds (5 times). (E) Standing on toes for 20 seconds (5 times).

(A) Spot marching (2 min). (B) Walking over the heels, toes, lateral border of feet with the preferred speed (6 min). (C) Tandem walking in a straight line (2 min).

Primary outcomes

  1. Fall Efficiency Scale-International (FES-I)

    Time frame: 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.

  2. Timed up and go test (TUG)

    Time frame: 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

  3. Berg Balance Scale

    Time frame: 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.

  4. Modified Toronto Clinical Neuropathy Score (mTCNS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effect of Ankle Proprioception Training in Improving the Balance in Patients of Type 2 Diabetic Neuropathy

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 13, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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