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

Primary Purpose

Diabetic Polyneuropathy, Foot Injuries

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
gait analysis
Sponsored by
Recep Tayyip Erdogan University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Diabetic Polyneuropathy focused on measuring Diabetic Polyneuropathy, Lower Extremity Burn Injury, Spatio-Temporal Parameters of Gait, Gait Symmetry

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ankara Training and Research Hospital
  • Numune Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Study Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Speed
It is obtained after dividing the distance traveled by the ambulation time. It is expressed in centimeters per second (cm/sec)
Cadence
The rate at which a person walk, expressed in steps per minute (step/min). The average cadence is 100 - 115 steps/min.
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.
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)
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.
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.

Full Information

First Posted
August 22, 2018
Last Updated
September 26, 2018
Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Collaborators
Hacettepe University, Ankara Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03687840
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
February 11, 2018 (Actual)
Study Completion Date
March 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Collaborators
Hacettepe University, Ankara Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy, Foot Injuries
Keywords
Diabetic Polyneuropathy, Lower Extremity Burn Injury, Spatio-Temporal Parameters of Gait, Gait Symmetry

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Group
Arm Type
Other
Arm Description
Spatio-Temporal gait analysis of subjects with unilateral lower extremity burn injuries due to diabetic polyneuropathy.
Arm Title
Control Group
Arm Type
Other
Arm Description
Spatio-Temporal gait analysis of subjects with only diabetic polyneuropathy.
Intervention Type
Diagnostic Test
Intervention Name(s)
gait analysis
Intervention Description
Computerized gait analysis system was used to 3 times to evaluate the spatio-temporal parameters of gait.
Primary Outcome Measure Information:
Title
Step Length
Description
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.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Stride Length
Description
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.
Time Frame
1 week
Title
Step Width
Description
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.
Time Frame
1 week
Title
Foot Progression Angle
Description
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.
Time Frame
1 week
Title
Speed
Description
It is obtained after dividing the distance traveled by the ambulation time. It is expressed in centimeters per second (cm/sec)
Time Frame
1 week
Title
Cadence
Description
The rate at which a person walk, expressed in steps per minute (step/min). The average cadence is 100 - 115 steps/min.
Time Frame
1 week
Title
Percentage of Double Support
Description
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.
Time Frame
1 week
Title
Percentage of Stance
Description
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)
Time Frame
1 week
Title
Percentage of Swing
Description
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.
Time Frame
1 week
Title
Symmetry Index
Description
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.
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melek M. ERDEM, PT, M.Sc.
Organizational Affiliation
Tayyip Erdogan University Training and Research Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Semra TOPUZ, Assoc. Prof.
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kemal KISMET, Assoc. Prof.
Organizational Affiliation
Ankara Training and Research Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gonul KOC, MD
Organizational Affiliation
Ankara Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmet C. YASTI, Prof.
Organizational Affiliation
Numune Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Numune Training and Research Hospital
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.researchgate.net/profile/Melek_Erdem2
Citations:
PubMed Identifier
24656951
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.
Results Reference
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Spatio-Temporal Gait Parameters and Gait Symmetry In Diabetic Lower Extremity Burn Injury.

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