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临床试验/NCT01034813
NCT01034813终止不适用

Assessment of Joint Range of Motion and Cutaneous Functional Unit Recruitment: Association With Burn Scar Characteristics

United States Army Institute of Surgical Research1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
43
试验地点
1
主要终点
Range of motion

研究概览

简要总结

The purpose of this study is to determine the relationship between cutaneous functional unit(CFU)recruitment throughout the available active range of motion of a prescribed joint in normal subjects and patients with burn scars. Specifically, this study will determine if differences in CFU recruitment exist between normal subjects and individuals with burn scars at the dorsal hand, dorsal or volar forearm, or anterior or posterior arm during active range of motion of the MCP joint during flexion, or the wrist or elbow during flexion or extension, respectively.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

Range of motion

时间窗: 3-5 days

次要结局

  • Scar Hypertrophy(3--5 days)

研究者

发起方
United States Army Institute of Surgical Research
申办方类型
Fed
责任方
Sponsor

研究点 (1)

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