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Completed

NCT Number: NCT04157504

Evaluation of Physical Functions in Lower Limb Burn Injury

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ozden Ozkal

Ankara, 06100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical function assessment

Other

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

Primary outcomes

  1. Lower Extremity Function

    Time frame: 10 minutes

    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.

  2. Nottingham health profile

    Time frame: 10 minutes

    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 outcomes

  1. scar tissue assessment

    Time frame: 10 minutes

    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.

  2. Tampa kinesiophobia scale

    Time frame: 10 minutes

    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.

  3. Six minutes walk test

    Time frame: 10 minutes

    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.

  4. Timed up and go test

    Time frame: 5 minutes

    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

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Clinical Factors Affecting Physical Functions in Lower Limb Burn Injury

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 8, 2019
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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