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临床试验/NCT05493696
NCT05493696已完成不适用

Effect of Antigravity Treadmill (Alter G) Training on Gait Characteristics and Balance After Healed Adult Burns: A Randomized Controlled Trial

Umm Al-Qura University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
2
主要终点
Change in Gait characteristics

研究概览

简要总结

Severe burn injuries are associated with hypermetabolic responses and increased catabolism. These generalized changes lead to a vast loss of muscle mass and cause reduced muscle strength and endurance, limited walking ability, and reduced functional mobility Recently, the antigravity treadmill or lower body positive pressure (LBPP) technology has been developed as a unique system of maintaining a participant's body weight all through treadmill training and developing low-load treadmill walking using a unique treadmill system that allows gaining the benefits of low-load treadmill walking without interrupting with locomotion dynamics

详细描述

Objective

This single-blind randomized controlled trial aimed to examine the effects of antigravity treadmill training on gait characteristics and balance in healed adult burned patients.

Methods: Fifty-five adult burn patients were chosen to participate in this study, their ages ranged from 18 to 35 years. They were randomly allocated to Alter G (ALG) (n=22), and control (Cont) (n=23) groups. The control group received a traditional physical therapy program (TPTP), three times per week. In contrast, the experimental group received antigravity treadmill training (30 minutes,3 times/week, speed 0.1 m/sec, 75% body weight) in addition to the traditional physical therapy program given to the control group. All study participants followed the instructions recommended for the exercise performed (three days per week) in terms of intensity, type, and duration to limit any difference between groups, as well as instructions about not exercising the rest of the week. During the study period, both groups received standard medical care. outcome measures: gait characteristics and postural stability indices were measured at the baseline (pre) and end of 12 weeks of intervention (post). The Statistical Package for the Social Sciences (SPSS) software was used for statistical analysis. The Shapiro-Wilk test was used to determine the normality of the data. The paired t-test was used to test within-group comparisons of mean changes in muscle strength, gait characteristics, and postural stability indices. The unpaired t-test was used to compare between groups. P<0.05 was chosen as the level of significance.

研究设计

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

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with circumferential lower limb deep second to third-degree thermal injury
  • Burns extending from the lower trunk to the foot were considered
  • The total body surface area (TBSA) ranges from 35 to 50%
  • All patients completed the same physical therapy program during hospitalization peroid

排除标准

  • Lower limb prosthesis
  • Severe musculoskeletal disorders
  • Serious cardiovascular insult
  • Participation in an outside physical training program
  • Medication that negatively impacts the study's results
  • Brain injury
  • Vestibular disorders
  • Visual disorders
  • History of epilepsy

结局指标

主要结局

Change in Gait characteristics

时间窗: At baseline and after 12 weeks

Step length (cm)

Change in Postural stability indices

时间窗: At baseline and after 12 weeks

Medio-lateral Stability Index (MLI)

次要结局

未报告次要终点

研究者

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

Anwar Abdelgayed Ebid

Professor Physical Therapy, Faculty of Applied Medical Sciences

Umm Al-Qura University

研究点 (2)

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