- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04157504
Evaluation of Physical Functions in Lower Limb Burn Injury
Clinical Factors Affecting Physical Functions in Lower Limb Burn Injury
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ankara, Kalkun, 06100
- Ozden Ozkal
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Experimental Group: Physical Function
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.
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Physical function assessment is a tool to evaluate mobility levels of patients
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Lower Extremity Function
Tidsramme: 10 minutes
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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.
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10 minutes
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Nottingham health profile
Tidsramme: 10 minutes
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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.
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10 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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scar tissue assessment
Tidsramme: 10 minutes
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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.
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10 minutes
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Tampa kinesiophobia scale
Tidsramme: 10 minutes
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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.
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10 minutes
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Six minutes walk test
Tidsramme: 10 minutes
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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.
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10 minutes
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Timed up and go test
Tidsramme: 5 minutes
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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
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5 minutes
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GO 17/419
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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