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临床试验/NCT05197127
NCT05197127已完成不适用

Implementing a Robotic Hip Assist-based Mobility Intervention for Older Adults With Frailty

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年9月14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
12
试验地点
2
主要终点
Change in 10 Meter Walk Test Speed

研究概览

简要总结

The purpose of this study is to evaluate the feasibility of using Samsung robotic hip assist-based mobility intervention for older adults with frailty.

The specific aims of this project are:

Aim 1 Will investigate the feasibility of the Samsung robotic hip assist-based mobility intervention on gait function, sedentary time, and fall risk.

Hypothesis: A 6-week robotic device-based mobility intervention will improve locomotor gait function, sedentary time, and fall risk.

详细描述

Twelve individuals above the age of 65 years old were recruited to participate in twelve sessions that occurred 2-3 times per week over a 4-6 week period using the GEMS-H. In addition to selecting individuals over the age of 65, qualifying participants also had to be able to walk with or without an assistive device for greater than ten feet. Medical clearance was obtained from each participant's primary physician prior to training with the device.

Gait training included dynamic over-ground walking (both self-selected and fast-paced), variable conditions of multidirectional walking, and training on ramps, stairs, and obstacle negotiation. All training was done under the supervision of a trained physical therapist. The amount of assistance and resistance torque provided by the hip motors of the GEMS-H was personalized according to each participant's specific abilities and self-reported tolerance/comfort throughout each session. These modifications followed a training progression model of increasing resistance and decreasing assistance over the course of the twelve sessions to maximize the challenge and improve strength and endurance in each participant.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • They are primarily English speaking
  • > 65 years of age
  • Able to walk with or without an assistive device >10 feet
  • Able to obtain medical clearance from the participant's primary physician
  • We will not include any special populations in this study

排除标准

  • Cannot comprehend or provide inform consent
  • Unable to fit the device within the hip frame size of310mm-380mm (approximately 12-15 inches)
  • Other weight and length limitations that restrict the proper fit of the device
  • Any significant neurological diagnosis impacting safe use of the device

结局指标

主要结局

Change in 10 Meter Walk Test Speed

时间窗: 0 weeks and through study completion (average of 4-6 weeks)

Average walking speed measured over 10 meters, tested at self selected velocity and fast velocity

Change in 6 minute walk test distance

时间窗: 0 weeks and through study completion (average of 4-6 weeks)

distance in meters covered in six minutes

Change in Berg Balance Scale Score

时间窗: 0 weeks and through study completion (average of 4-6 weeks)

Total score across 14 items in the Berg Balance Scale, scored 0-56 (maximum score is 56)

Change in Functional Gait Assessment Score

时间窗: 0 weeks and through study completion (average of 4-6 weeks)

Total score across 10 items in the Functional Gait Assessment, scored 0-30 (maximum score is 30)

Change in 5 Times Sit-to-Stand Time

时间窗: 0 weeks and through study completion (average of 4-6 weeks)

The time required to stand up and sit down from a chair five times without assistance

次要结局

  • Change in Sedentary Bouts per day(0 weeks and through study completion (average of 4-6 weeks))

研究者

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

Arun Jayaraman, PT, PhD

Director, Max Nader Lab

Shirley Ryan AbilityLab

研究点 (2)

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