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临床试验/NCT03558100
NCT03558100已完成不适用

A Nonrandomized Controlled Trial of an Obstacle Crossing Intervention for Adults Before Bariatric Surgery

Boston University Charles River Campus0 个研究点目标入组 100 人开始时间: 2014年9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
发起方
入组人数
100
主要终点
Velocity (cm/s)

研究概览

简要总结

The objective of the clinical study was to examine if practice could improve walking patterns associated with fall risks before patients with obesity underwent weight loss surgery. We hypothesized that patients would show improvements in their walking after completing the intervention. For the intervention, patients walked under five conditions: on flat ground at the beginning of the study, crossing three obstacle heights, and on flat ground at the end of the study for a total of 25 times.

详细描述

Obesity has a negative impact on aspects of walking associated with fall risks. After weight loss surgery, adults show improvements in walking. However, those who undergo surgery still show deficits in walking and an additional group of individuals do not undergo the procedure. Our objective was to examine if practice could improve gait patterns associated with fall risks before patients underwent weight loss surgery. Adults with obese body mass index between 30 to 60 years old who were eligible to undergo the Roux-en-Y weight loss surgery procedure walked under five conditions: initial baseline walking on flat ground, crossing three obstacle heights, and final baseline walking on flat ground for a total of 25 trials. Spatio-temporal gait parameters were collected using a gait carpet and body-worn sensors. The GAITRite mat was a 4.9 m long x 0.6 m wide pressure-sensitive mat with a temporal resolution of 120 Hz and a spatial resolution of 1.3 cm. LEGSysTM includes five wearable sensors containing triaxial gyroscopes, accelerometers, and magnetometers. Dependent variables selected included velocity (cm/s), cadence (steps/minute), step length (distance between consecutive steps), step width (lateral distance between feet), single limb support time (amount of time spent on one leg during the walking cycle), and double limb support time (amount of time spend on two legs during the walking cycle).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • between 30 and 60 years old
  • eligible to undergo Roux-en-Y gastric bypass surgery
  • walk independently without assistive devices

排除标准

  • scheduled to undergo knee surgery
  • receiving dialysis
  • being treated for cancer

研究组 & 干预措施

Reducing Fall Risks in Obesity

Experimental

Adults with obesity will be asked to perform the obstacle crossing intervention for adults with obesity for reducing falls risk. This will involve crossing obstacles of different heights under five conditions: initial baseline walking on flat ground, crossing three obstacle heights, and final baseline walking on flat ground for a total of 25 trials. Spatio-temporal gait parameters will be collected using a gait carpet and body-worn sensors.

干预措施: Obstacle crossing intervention for adults with obesity (Behavioral)

结局指标

主要结局

Velocity (cm/s)

时间窗: The change from baseline velocity (cm/s) at 12 months

walking speed

次要结局

  • Cadence (steps per minute)(The change from baseline cadence (steps per minute) at 12 months)
  • Step width (cm)(The change from baseline step width (cm) at 12 months)
  • double limb support time (msec)(The change from baseline double limb support time (msec) at 12 months)
  • single limb support time (msec)(The change from baseline single limb support time (msec) at 12 months)
  • step length (cm)(The change from baseline step length (cm) at 12 months)

研究者

发起方
Boston University Charles River Campus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone V. Gill

Associate Professor

Boston University Charles River Campus

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