Clinical trial NCT03687840: Spatio-Temporal Gait Parameters and Gait Symmetry In Diabetic Lower Extremity Burn Injury.
Official title: Evaluation of Spatio-Temporal Gait Parameters and Gait Symmetry In Diabetic Polyneuropathic Individuals With Lower Extremity Burn Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Foot Injuries
Keywords: Diabetic Polyneuropathy
Lower Extremity Burn Injury
Spatio-Temporal Parameters of Gait
Gait Symmetry
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Hacettepe University
name: Ankara Training and Research Hospital
First posted: 2018-09-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Step Length
timeFrame: 1 week
Secondary outcomes:
measure: Stride Length
timeFrame: 1 week
measure: Step Width
timeFrame: 1 week
measure: Foot Progression Angle
timeFrame: 1 week
measure: Speed
timeFrame: 1 week
measure: Cadence
timeFrame: 1 week
measure: Percentage of Double Support
timeFrame: 1 week
measure: Percentage of Stance
timeFrame: 1 week
measure: Percentage of Swing
timeFrame: 1 week
measure: Symmetry Index
timeFrame: 1 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
state: Cankaya
city: Ankara
country: Turkey
facility: Numune Training and Research Hospital
state: Cankaya
Study officials:
affiliation: Tayyip Erdogan University Training and Research Hospital
name: Melek M. ERDEM, PT, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Semra TOPUZ, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Ankara Training and Research Hospital
name: Kemal KISMET, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Ankara Training and Research Hospital
name: Gonul KOC, MD
role: STUDY_CHAIR
affiliation: Numune Training and Research Hospital
name: Ahmet C. YASTI, Prof.
role: STUDY_CHAIR
References:
citation: 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.