Burns Clinical Trial
Official title:
Clinical Factors Affecting Physical Functions in Lower Limb Burn Injury
NCT number | NCT04157504 |
Other study ID # | GO 17/419 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 10, 2018 |
Est. completion date | May 1, 2020 |
Verified date | August 2020 |
Source | Hacettepe University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Ozden Ozkal | Ankara |
Lead Sponsor | Collaborator |
---|---|
Hacettepe University |
Turkey,
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 |
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