- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01034813
Joint Range of Motion in Burn Scars
Assessment of Joint Range of Motion and Cutaneous Functional Unit Recruitment: Association With Burn Scar Characteristics
Přehled studie
Postavení
Detailní popis
Specific Aim #1: To establish the relationship between joint position and skin recruitment, expressed as the percentage of CFU recruited during active ROM, in patients with burn scars and normal controls.
Specific Aim #2: To establish the within-day and between-day reliability of percent CFU estimation and absolute skin recruitment, measured in millimeters from a fixed reference, during active ROM for a specified joint.
Specific Aim #3: To establish the relationship between scar height, measured by diagnostic ultrasound, scar cross-sectional area, and percent CFU recruitment in individuals with burn scar.
Specific Aim #4: To determine whether the amount of skin recruitment, expressed as the percent of the CFU recruited during active ROM, is differentially affected by burn scar.
Ho: There is no difference in the percent CFU recruited at the completion of active range of motion at a specified joint between individuals with burn scars and normal controls.
Ha: Individuals with burn scars recruit a greater percentage of the CFU in order to obtain maximal range of motion at a specified joint.
Specific Aim #5: To determine whether the timing of skin recruitment, expressed as the initiation of skin movement within a CFU relative to joint position during active ROM, is differentially affected by burn scar.
Ho: There is no difference in the initiation of skin movement within a CFU relative to joint position during active ROM at a specified joint between individuals with burn scars and normal controls.
Ha: In individuals with burn scars in a given CFU, skin movement farther from the joint axis occurs earlier in the range of motion compared to controls.
Specific Aim #6: To determine whether skin extensibility within a CFU during active ROM of a specified joint is differentially affected by burn scar.
Ho: There is no difference skin extensibility within a CFU during active ROM of a specified joint between individuals with burn scars and normal controls.
Ha: In individuals with burn scars in a given CFU, skin near the joint axis undergoes greater deformation (stretch) as range of motion at the joint increases compared to controls.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Texas
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Fort Sam Houston, Texas, Spojené státy, 78234
- USAISR
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Inclusion Criteria include: 1) male or female burn survivors between the ages of 18 and 60, 2) an area of scar covering at least fifty percent of the CFU of interest, 3) control subjects must have full active range of motion of the metacarpal phalangeal joints, wrist and elbow according to published normative references and be free of any history neuromusculoskeletal injury within the last three years that involved the joints of interest.
Exclusion Criteria:
- Exclusion Criteria include: 1)burn survivors with an area of scar of less than fifty percent of the CFU of interest, 2) burn survivors with a history of orthopedic trauma to the upper extremity (i.e. sprain within the last 24 months, history of fracture, or history of joint dislocation), 3) control subjects with a history of upper extremity trauma or injury, 4) control subjects with the presence of scar tissue covering an area of more than one percent of the CFU of interest, 5) any potential subject with a history or rheumatoid arthritis, osteoarthritis affecting the extremity of interest, peripheral nerve injury of the extremity of interest, or systemic disorder affecting joint range of motion of the upper extremity.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
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Burn Range of motion
burn patients with hypertropic scar
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control range of motion
control subjects without scaring
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Range of motion
Časové okno: 3-5 days
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3-5 days
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Scar Hypertrophy
Časové okno: 3--5 days
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3--5 days
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: William S Dewey, PT, CHT, United States Army Institute of Surgical Research
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- H-09-039
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