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Evaluation of Physical Functions in Lower Limb Burn Injury

Primary Purpose

Burns, Burn Scar, Lower Limb Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Physical function assessment
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Burns focused on measuring Burn Injury, Balance, Lower extremity function, burn scar

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Having a lower limb burns
  • To be a volunteer to participate

Exclusion Criteria:

  • orthopedic problems affecting gait and stance
  • Having a neurological disorders
  • Walking with assist device

Sites / Locations

  • Ozden Ozkal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group: Physical Function

Arm Description

Forty patients with burn injury will be evaluated in this study. Lower extremity function, functional capacity, functional mobility, quality of life an scar tissue will be evaluated.

Outcomes

Primary Outcome Measures

Lower Extremity Function
The Lower extremity functional index is a questionnaire containing 25 items. The value of this questionnaire between 0 and 100. The higher value indicates worse physical function.
Nottingham health profile
Nottingham health profile is a questionnaire that evaluates quality of life. he lowest and highest scores that can be obtained from each sub-dimension of the scale are 0 and 100, respectively. 0 indicates the best health status while 100 indicates the worst health status.

Secondary Outcome Measures

scar tissue assessment
The Patient and Observer Scar Assessment Scale consists of the total score of two numeric scales measured by the patient and a qualified observer. Each scale assesses the scar by six characteristics on 10-point scales with a 1 corresponding to normal skin and a 10 representing the worst imaginable condition for that characteristic. The Total Score of both scales is calculated by summing scores of the six items resulting in a range of 6 to 60.
Tampa kinesiophobia scale
This scale consists of a 17-item self-report questionnaire that measures the fear of re-injury because of movement. Items are scored on a 4-point Likert scale ranging from 1 "strongly disagree" to 4 "strongly agree". The total scores for scale range from 17 to 68. Maximum score means higher level of kinesiophobia.
Six minutes walk test
It was evaluated by six minutes walk test.The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The distance will be recorded. The higher distance is indicated better exercise capacity.
Timed up and go test
Timed up and go test evaluates dynamic balance of participants. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.Timed up and go test measure is second. The lower values indicates the better balance

Full Information

First Posted
November 6, 2019
Last Updated
August 25, 2020
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT04157504
Brief Title
Evaluation of Physical Functions in Lower Limb Burn Injury
Official Title
Clinical Factors Affecting Physical Functions in Lower Limb Burn Injury
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

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 evaluates scar tissue, normal range of motion of lowr extremity joints, lower extremity functions, functional capacity, functional mobility, kinesiophobia and quality of life in lower limb burn injury.
Detailed Description
Patients with lower extremity burns experience problems with range of motion, muscle strength, balance and gait. These problems contribute to prolonged physical disability, return to work or deterioration of work capacity and thus lead to a negative impact on quality of life. In addition to studies showing that quality of life and functions may be affected adversely after burn, there are studies showing that burn percentage, health-related quality of life and functional outcomes are affected. The aim of this study is to determine the effects of burn area (with or without joint), percentage of burns and hypertrophic scar on the patient's function in patients with lower extremity burns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Burn Scar, Lower Limb Injury, Lower Limb Wound
Keywords
Burn Injury, Balance, Lower extremity function, burn scar

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group: Physical Function
Arm Type
Experimental
Arm Description
Forty patients with burn injury will be evaluated in this study. Lower extremity function, functional capacity, functional mobility, quality of life an scar tissue will be evaluated.
Intervention Type
Other
Intervention Name(s)
Physical function assessment
Intervention Description
Physical function assessment is a tool to evaluate mobility levels of patients
Primary Outcome Measure Information:
Title
Lower Extremity Function
Description
The Lower extremity functional index is a questionnaire containing 25 items. The value of this questionnaire between 0 and 100. The higher value indicates worse physical function.
Time Frame
10 minutes
Title
Nottingham health profile
Description
Nottingham health profile is a questionnaire that evaluates quality of life. he lowest and highest scores that can be obtained from each sub-dimension of the scale are 0 and 100, respectively. 0 indicates the best health status while 100 indicates the worst health status.
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
scar tissue assessment
Description
The Patient and Observer Scar Assessment Scale consists of the total score of two numeric scales measured by the patient and a qualified observer. Each scale assesses the scar by six characteristics on 10-point scales with a 1 corresponding to normal skin and a 10 representing the worst imaginable condition for that characteristic. The Total Score of both scales is calculated by summing scores of the six items resulting in a range of 6 to 60.
Time Frame
10 minutes
Title
Tampa kinesiophobia scale
Description
This scale consists of a 17-item self-report questionnaire that measures the fear of re-injury because of movement. Items are scored on a 4-point Likert scale ranging from 1 "strongly disagree" to 4 "strongly agree". The total scores for scale range from 17 to 68. Maximum score means higher level of kinesiophobia.
Time Frame
10 minutes
Title
Six minutes walk test
Description
It was evaluated by six minutes walk test.The 6-min walk test is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The distance will be recorded. The higher distance is indicated better exercise capacity.
Time Frame
10 minutes
Title
Timed up and go test
Description
Timed up and go test evaluates dynamic balance of participants. The timed up and go test measures the time that a patient needs to stand up from a chair, walk a 3-m distance, come back and sit back on the chair.Timed up and go test measure is second. The lower values indicates the better balance
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having a lower limb burns To be a volunteer to participate Exclusion Criteria: orthopedic problems affecting gait and stance Having a neurological disorders Walking with assist device
Facility Information:
Facility Name
Ozden Ozkal
City
Ankara
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of Physical Functions in Lower Limb Burn Injury

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