Evaluation of Physical Functions in Lower Limb Burn Injury

Burns Clinical Trial

Official title:

Clinical Factors Affecting Physical Functions in Lower Limb Burn Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04157504
• Other study ID #: GO 17/419
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2020
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 1, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Scar
• Burns
• Leg Injuries
• Lower Limb Injury
• Lower Limb Wound
• Wounds and Injuries

Intervention

Other:
• Physical function assessment
Physical function assessment is a tool to evaluate mobility levels of patients

Locations

Country	Name	City	State
Turkey	Ozden Ozkal	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes
Primary	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.	10 minutes
Secondary	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.	10 minutes
Secondary	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.	10 minutes
Secondary	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.	10 minutes
Secondary	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	5 minutes