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临床试验/NCT03759613
NCT03759613已完成不适用

Evaluation of Gait Symmetry in Patients With Unilateral Upper Extremity Burn Injury

Hacettepe University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Stance Phase

研究概览

简要总结

Thirty patients with unilateral burn injury, and 60 healthy subjects will be included in this study. Participants with burn injury will evaluate with the following assessment tools: Demographic data; age, gender, height, body mass index; burn characteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded. Gait parameters (step length, stride length, base support, step time, cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait cycle). will be recorded via computerized system. And gait symmetry will be calculated via formule. Participants' kinesiophobia level will be evaluated with Tampa kinesiophobia scale. Their pain will be assessed by visual analog scale. Their arm swing will be evaluated by a scale.

详细描述

Thirty individuals with lower extremity burn injury and sixty healthy subjects will be included in this study. Participants with burn injury will be included if they are aged of 18-50, able to walk independently at least 10 meters. Healthy subjects will be included if there are no orthopedic, neurological or musculoskeletal disorders that affect gait.

  1. Group: 30 Patients with burn injury
  2. Group: 30 healthy subjects (When evaluating the gait analysis, their arm will not be restricted (Their natural walking)
  3. Group : 30 healthy subject (When evaluating the gait analysis, their arm will be restricted )

Participants will evaluate with the following assessment tools: Demographic data; age, gender, height, body mass index; burn characteristics; type of burn injury, degree of burn injury, localization of burn injury and total burn surface area will be recorded.

All subjects' gait analysis will be conducted via GAITRite (computerized) system.

GAITRite system for gait parameters (step length, stride length, base support, step time, cycle time, cadence, velocity, single support, double support, swing ( % of gait cycle) and stance (% of gait cycle), Tampa Kinesiophobia scale for kinesiophobia level, visual analog scale for pain, a scale that developed by us for arm swing will be used.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of upper extremity burn injury
  • must be able to walk independently
  • Control group consists of healthy adults with the similar demographic characteristics as experimental group.

排除标准

  • Walking with assist device
  • Having a visual deficits
  • Having an orthopedic problems that affect gait
  • Having a neurological disorders
  • Having a musculoskeletal disorders that affect gait
  • Having an undergone orthopedic surgery

研究组 & 干预措施

Experimental Group

Experimental

Thirty subjects with unilateral upper burn injury will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. Their evaluations will be made within 5 days following burn injury.

干预措施: Gait Analysis (Other)

Control Group

Active Comparator

Thirty healthy subjects will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. When their gait analysis made, they will be asked to walk their natural walking.

干预措施: Gait Analysis (Other)

Control Grup (Restricted arm swing)

Sham Comparator

Thirty healthy subjects will be included in this study. GAITRite system for gait analysis, Tampa kinesiophobia scale for kinesiophobia level, visual analog scale for pain and a scale that developed by us for arm swing will be used. When their gait analysis made, their arms will be fixed with a bandage on their bodies. Their arm swing will be restricted.

干预措施: Gait Analysis (Other)

结局指标

主要结局

Stance Phase

时间窗: through study completion, an average of 5 months

It is measured by computerized gait analysis system.The gait phase that lasts from heel strike to toe off, which accounts for 60% of a single gait cycle. It is expressed in seconds (sec) and as a percentage of the gait cycle of the same foot. It is calculated both right and left foot.

Cadence

时间窗: through study completion, an average of 5 months

It is measured by computerized gait analysis system. Rhythm expressed in steps per second.

Base support

时间窗: through study completion, an average of 5 months.

It is measured by computerized gait analysis system. It is the distance between two linescutting feet equal halves. The unit of measure is centimeters.

Gait Speed

时间窗: through study completion, an average of 5 months

It is measured by computerized gait analysis system. Speed is the distance walked per unit of time. It is determined in centimeters per second (cm/sec)

Single Support

时间窗: through study completion, an average of 5 months

It is measured by computerized gait analysis system. Only one foot in contact with the floor. It is expressed as a percentage of the gait cycle. It is calculated both right and left foot.

step length

时间窗: through study completion, an average of 5 months

It is measured by computerized gait analysis system. Difference in position between the feet at heel strike, in the direction of forward motion. The unit of measure is centimeters. It is calculated both right and left foot.

Swing phase

时间窗: through study completion, an average of 5 months

It is measured by computerized gait analysis system. Swing Phase,which accounts for 40% of a single gait cycle, the phase during which the foot is not in contact with the ground. It is expressed in seconds (sec) and as a percentage of the gait cycle of the same foot. It is calculated both right and left foot.

Double Support

时间窗: through study completion, an average of 5 months

It is measured by computerized gait analysis system. Boot feet in contact with the floor. It is expressed as a percentage of the gait cycle. It is calculated both right and left foot.

Gait symmetry index

时间窗: through study completion, an average of 5 months

It's calculated in order to evaluate symmetry for bilateral parameters of gait. The value of symmetry index =0 equals full symmetry. Minimum score is 0 indicates perfect symmetry. Maximum score is endless. The higher score is indicated the more asymmetrica gait pattern.

次要结局

  • Tampa Kinesiophobia Scale(through study completion, an average of 5 months)
  • Arm swing(through study completion, an average of 5 months)
  • Pain severity(through study completion, an average of 5 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozden Ozkal

Principal Investigator

Hacettepe University

研究点 (2)

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