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Clinical Trials/NCT03687840
NCT03687840
Completed
Not Applicable

Evaluation of Spatio-Temporal Gait Parameters and Gait Symmetry In Diabetic Polyneuropathic Individuals With Lower Extremity Burn Injury

Recep Tayyip Erdogan University Training and Research Hospital2 sites in 1 country28 target enrollmentFebruary 14, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Polyneuropathy
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Enrollment
28
Locations
2
Primary Endpoint
Step Length
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

This study evaluated the spatio-temporal gait parameters and gait symmetry in individuals with lower extremity burn injury due to diabetic polyneuropathy. Study group consisted of 14 subjects with unilateral lower extremity burn injuries due to diabetic polyneuropathy and control group consisted of 14 subjects with only diabetic polyneuropathy.

Detailed Description

Diabetic polyneuropathy, a frequent complication of diabetes, is used to describe sensory, motor and autonomic nerve damage caused by metabolic and micro vessel alterations due to hyperglycaemia. The signs and symptoms of diabetic polyneuropathy vary according to the type of nerve fiber affected. The involvement of the small nerve fibers results in deterioration of the pain and temperature perception, while the impairing of large nerve fibers result in decrease of touch and proprioception sensations. Due to the sensory loss, accidental foot injuries may develop in patients with diabetic polyneuropathy. While the feet constitute a small percentage (3.5%) of the total body surface area, burn injuries of them in patients with diabetic polyneuropathy can cause significant effects on quality of life because impaired wound healing process in diabetics may cause risk of prolonged bed rest and hospitalization period, and increased early and late complications. Therefore, it has an important effects on daily living activities because it causes inadequacies in gait and balance activities due to the negative effects on mobility and weight bearing functions. In studies that examining changes in gait parameters in other diabetic foot complications such as sensory loss, ulceration, and amputation as secondary to diabetic polyneuropathy have shown that these individuals acquire a protective adaptive gait strategies that allow for more controlled gait in the present of proprioceptive deficits such as slower gait speed, smaller step length and in particular increased opposite foot off time in order to shift body weight from injured limb to unaffected side. There's no studies have yet been conducted to investigating of changes in gait parameters in patients who have diabetic polyneuropathy-related lower extremity burn injury. The aim of this case-control study is to examine whether similar gait strategies have been gained in this group of patients, as indicated in the results of previous studies demonstrating protective adaptive gait strategies that adopt under the presence of other diabetic foot complications due to diabetic polyneuropathy.

Registry
clinicaltrials.gov
Start Date
February 14, 2017
End Date
March 11, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Melek Merve ERDEM

Research Assistant

Recep Tayyip Erdogan University Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Study group, include cases with a diagnosis of diabetic polyneuropathy and unilateral lower limb burn injury.
  • Control group consists of adults with a confirmed diagnosis of diabetic polyneuropathy without burn injury.

Exclusion Criteria

  • presence of active ulcerations
  • presence of other diabetic morbidities (nephropathy, retinopathy, vestibulopathy)
  • orthopedic, musculoskeletal, neurological problems or previous surgical interventions that may affect the mobility and original gait dynamics except for diabetic polyneuropathy,
  • using of assistive devices
  • body mass index\> 40 kg/m²

Outcomes

Primary Outcomes

Step Length

Time Frame: 1 week

It is measured along the length of the walkway, from the heel center of the current footprint to the heel center of the previous footprint on the opposite foot.The unit of measure is centimeters.

Secondary Outcomes

  • Stride Length(1 week)
  • Speed(1 week)
  • Cadence(1 week)
  • Step Width(1 week)
  • Percentage of Double Support(1 week)
  • Percentage of Swing(1 week)
  • Symmetry Index(1 week)
  • Foot Progression Angle(1 week)
  • Percentage of Stance(1 week)

Study Sites (2)

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