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

NCT ID: NCT03687840

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-14
• Study Completion Date: 2018-03-11

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.

Conditions

Diabetic Polyneuropathy; Foot Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Study Group

Spatio-Temporal gait analysis of subjects with unilateral lower extremity burn injuries due to diabetic polyneuropathy.

Group Type: OTHER

gait analysis

Intervention Type: DIAGNOSTIC_TEST

Computerized gait analysis system was used to 3 times to evaluate the spatio-temporal parameters of gait.

Control Group

Spatio-Temporal gait analysis of subjects with only diabetic polyneuropathy.

Group Type: OTHER

gait analysis

Intervention Type: DIAGNOSTIC_TEST

Computerized gait analysis system was used to 3 times to evaluate the spatio-temporal parameters of gait.

Interventions

gait analysis

Computerized gait analysis system was used to 3 times to evaluate the spatio-temporal parameters of gait.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: collaborator

Ankara Training and Research Hospital

OTHER

Sponsor Role: collaborator

Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Melek Merve ERDEM

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melek M. ERDEM, PT, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Tayyip Erdogan University Training and Research Hospital

Semra TOPUZ, Assoc. Prof.

Role: STUDY_DIRECTOR

Hacettepe University

Kemal KISMET, Assoc. Prof.

Role: STUDY_DIRECTOR

Ankara Training and Research Hospital

Gonul KOC, MD

Role: STUDY_CHAIR

Ankara Training and Research Hospital

Ahmet C. YASTI, Prof.

Role: STUDY_CHAIR

Numune Training and Research Hospital

Locations

Ankara Training and Research Hospital

Ankara, Cankaya, Turkey (Türkiye)

Numune Training and Research Hospital

Ankara, Cankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 24656951 (View on PubMed)

Other Identifiers

GO 17/07

Identifier Type: -

Identifier Source: org_study_id