Spatio-Temporal Gait Parameters and Gait Symmetry In Diabetic Lower Extremity Burn Injury.

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

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.

Study Overview

• Status: Completed
• Conditions: Foot Injuries; Diabetic Polyneuropathy
• Intervention / Treatment: Diagnostic test: gait analysis

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey, 06100
      • Ankara Training and Research Hospital
    • Ankara, Cankaya, Turkey, 06100
      • Numune Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Study Group; Spatio-Temporal gait analysis of subjects with unilateral lower extremity burn injuries due to diabetic polyneuropathy.	Diagnostic test: gait analysis; Computerized gait analysis system was used to 3 times to evaluate the spatio-temporal parameters of gait.
OTHER: Control Group; Spatio-Temporal gait analysis of subjects with only diabetic polyneuropathy.	Diagnostic test: gait analysis; Computerized gait analysis system was used to 3 times to evaluate the spatio-temporal parameters of gait.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step Length	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stride Length	It is measured on the line of progression between the heel points of two consecutive footprints of the same foot (left to left, right to right). The unit of measure is centimeters.	1 week
Step Width	It is measured from the midline midpoint of the current footprint to the midline midpoint of the previous footprint on the opposite foot.The unit of measure is centimeters.	1 week
Foot Progression Angle	It is the angle between the line of progression and the midline of the footprint. This angle is zero if the geometric mid- line of the footprint is parallel to the line of progression; positive, toe-out, when the mid-line of the footprint is outside the line of progression and negative, toe-in, when inside the line of progression. The unit of measure is degrees.	1 week
Speed	It is obtained after dividing the distance traveled by the ambulation time. It is expressed in centimeters per second (cm/sec)	1 week
Cadence	The rate at which a person walk, expressed in steps per minute (step/min). The average cadence is 100 - 115 steps/min.	1 week
Percentage of Double Support	It is the amount of time that a person spends with both feet on the ground during one gait cycle. It is presented as a percentage of the gait cycle time (% gait cycle). The percentage of time spent in double support decreases as the speed of walking increases.	1 week
Percentage of Stance	The stance phase is the weight bearing portion of each gait cycle. It is initiated by heel contact and ends with toe off of the same foot. It is the time elapsed between the first contact and the last contact of two consecutive footfalls on the same foot. It is also presented as a percentage of the gait cycle time (% gait cycle)	1 week
Percentage of Swing	It is initiated with toe off and ends with heel strike. It is the time elapsed between the last contact of the current footfall to the first contact of the next footfall on the same foot. It is expressed in seconds (sec) and it is also presented as a percent of the gait cycle (% gait cycle) of the same foot. The Swing Time is equal to the Single Support time of the opposite foot.	1 week
Symmetry Index	It's calculated in order to evaluate symmetry and bilateral coordination of gait. The Symmetry Index and Symmetry Angle are interpreted as a complete symmetry if the result is 0. Evaluation of asymmetries observed in the spatio-temporal characteristics, a deviation of at least 10% from the 0 value for exact symmetry.	1 week

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Collaborators: Hacettepe University; Ankara Training and Research Hospital
• Investigators: Study Director: Kemal KISMET, Assoc. Prof., Ankara Training and Research Hospital; Study Chair: Gonul KOC, MD, Ankara Training and Research Hospital; Study Chair: Ahmet C. YASTI, Prof., Numune Training and Research Hospital

Publications and helpful links

General Publications

• Jones LM, Coffey R, Khandelwal S, Atway S, Gordillo G, Murphy C, Fries JA, Dungan K. A clinician's guide to the treatment of foot burns occurring in diabetic patients. Burns. 2014 Dec;40(8):1696-701. doi: 10.1016/j.burns.2014.01.026. Epub 2014 Mar 20.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 14, 2017
• Primary Completion (ACTUAL): February 11, 2018
• Study Completion (ACTUAL): March 11, 2018

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (ACTUAL): September 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Spatio-Temporal Parameters of Gait; Gait Symmetry; Diabetic Polyneuropathy; Lower Extremity Burn Injury
• Additional Relevant MeSH Terms: Nervous System Diseases; Leg Injuries; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Burns; Wounds and Injuries; Polyneuropathies; Diabetic Neuropathies; Foot Injuries
• Other Study ID Numbers: GO 17/07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will be available within 6 months with completion of the result report.
• IPD Sharing Access Criteria: Requestors will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No