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临床试验/NCT05734443
NCT05734443已完成不适用

Effects of Task-Specific Step Training on Reactive Balance After Laboratory-Induced Trips: A Pilot Trial

Virginia Polytechnic Institute and State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11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
30
试验地点
1
主要终点
Trunk Angle at Touchdown of the First Recovery Step

研究概览

简要总结

The goal of this clinical trial is to evaluate a novel and pragmatic (i.e., not requiring specialized equipment) task-specific step training regimen that aims to improve reactive balance after tripping. The main questions it aims to answer are:

  • Does this step training regimen improve reactive balance after tripping compared to no training?
  • How well does this step training regimen improve reactive balance compared to treadmill training, which is a more commonly studied reactive balance training regimen that uses a specialized treadmill.

Participants will:

  • complete step training or treadmill training (or no training if assigned to the control group) twice a week for three weeks
  • experience a laboratory-induced trip three weeks later to evaluate their reactive balance

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •65-80 years old
  • •willing to use wearable sensors for 2-3 weeks (for a separate study)
  • •no lower limb amputation
  • •not weigh over 250 pounds
  • •pass a telephone interview related to cognitive status

排除标准

  • •participants must pass a health screening involving a questionnaire that will be reviewed by a health care specialist.
  • •participants must not have clinical osteoporosis as indicated by a bone mineral density of the lumbar vertebra and proximal femur of t<-2.0 as obtained from dual energy x-ray absorptiometry (DEXA), or a DEXA scan completed within the last year.

研究组 & 干预措施

step training

Experimental

Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated volitional and reactive stepping movements that mimic the movements necessary to recover balance after tripping while walking.

干预措施: step training (Behavioral)

treadmill training

Experimental

Two training sessions per week will be completed for three consecutive weeks. Each training session will last 0.5-1 hour with an active training time of 30 minutes per participant. Training will involve repeated exposure to simulated trips on a treadmill. To simulate a trip, participants first stand on the stationary treadmill belt. A sudden and unexpected increase in backward treadmill belt speed induces a forward loss of balance similar to when tripping. Participants are then required to take steps to recover balance and establish a stable gait pattern before the trial ends. Trials are repeated using pseudo-random speeds that provide variability and are individualized to each participant's capabilities.

干预措施: treadmill training (Behavioral)

Control

No Intervention

结局指标

主要结局

Trunk Angle at Touchdown of the First Recovery Step

时间窗: 1 week after the 3-week intervention

After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers

Trip Outcome

时间窗: 1 week after the 3-week intervention

This is a binary variable that has a value of either "fall" or "recovery." After a laboratory-induced trip, trip outcome will be assign to one of the following two values: "fall" if a participant is fully and continuously supported by the harness as observed from video, or if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is greater than 40% of body weight \* seconds. The harness force will be measured by a uniaxial load cell. "recovery" if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is less than 40% of body weight \* seconds. The harness force will be measured by a uniaxial load cell.

Trunk Angle at Touchdown of the First Recovery Step

时间窗: 1 week after the 3-week intervention

After a laboratory-induced trip: Angle from vertical of a line connecting midpoint of greater trochanter markers and midpoint of the acromion markers

Trip Outcome

时间窗: 1 week after the 3-week intervention

This is a binary variable that has a value of either "fall" or "recovery." After a laboratory-induced trip, trip outcome will be assign to one of the following two values: "fall" if a participant is fully and continuously supported by the harness as observed from video, or if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is greater than 40% of body weight \* seconds. The harness force will be measured by a uniaxial load cell. "recovery" if the harness force applied to the participant, integrated over time from trip onset until 1 second after touchdown of the first recovery step, is less than 40% of body weight \* seconds. The harness force will be measured by a uniaxial load cell.

次要结局

  • Average Step Speed(1 week after the 3-week intervention)
  • Trip Recovery Strategy(1 week after the 3-week intervention)
  • Recovery Step Length(1 week after the 3-week intervention)
  • Sacrum Height at Touchdown of the First Recovery Step(1 week after the 3-week intervention)
  • Gait Speed(1 week after the 3-week intervention)
  • Recovery Step Length(1 week after the 3-week intervention)
  • Sacrum Height at Touchdown of the First Recovery Step(1 week after the 3-week intervention)
  • Gait Speed(1 week after the 3-week intervention)
  • Average Step Speed(1 week after the 3-week intervention)
  • Trip Recovery Strategy(1 week after the 3-week intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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