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临床试验/NCT04091464
NCT04091464已完成不适用

TRAIN-BW: Backward Walking Training in Multiple Sclerosis

Wayne State University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年1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
90
试验地点
1
主要终点
Sway during quiet stance

研究概览

简要总结

Individuals with multiple sclerosis (MS) experience in impairments in mobility and cognition that increase the risk for accidental falls. More than 50% of individuals with MS experience injurious falls within a 6-month period. Current interventions to improve fall risk have focused on forward walking (FW) and balance training, resulting in small declines in the relative risk for falls with a large degree of variability. Interestingly, motor differences between MS and healthy controls are more pronounced in backward walking (BW), yet no studies have investigated BW training as an intervention to reduce fall risk in persons with MS. This study will investigate the feasibility, acceptability and impact of BW training compared to forward walking training on motor function and fall risk in persons with MS.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of MS
  • •PDDS <6, indicating ability to ambulate with or without an assistive device >/= 50% of the time
  • •Self-reported walking dysfunction as evidenced by a score of >/= 30 on MSWS-12 OR reports of 2 or more falls in the prior 6 months, indicating a frequent faller.

排除标准

  • •MS relapse within the past 30 days
  • •comorbid neurological disorder
  • •acute orthopedic disorder/injury
  • •unable to follow study-related commands

研究组 & 干预措施

TRAIN-FW

Active Comparator

1x/week for 8 weeks + home exercise program

干预措施: Forward Walking Training (Behavioral)

TRAIN-BW

Experimental

1x/week for 8 weeks + home exercise program

干预措施: Backward Walking Training (Behavioral)

结局指标

主要结局

Sway during quiet stance

时间窗: Change in sway at 8 weeks

Measured with APDM Sensors

Stepping latency on push-and-release test

时间窗: Change in stepping latency at 8 weeks

Measured with APDM Sensors

次要结局

  • Number of Active Minutes(Change in Physical Activity measures at 8 weeks)
  • Number of Falls(6 months)
  • Forward and Backward Velocity and Double Support Time(Change in velocity and double support time at 8 weeks)
  • Patient Global Impression of Change(8 weeks)
  • Client Satisfaction Questionnaire (CSQ-8)(8 weeks)
  • ABC Scale(Change in balance confidence at 8 weeks)

研究者

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

Nora Fritz

Associate Professor

Wayne State University

研究点 (1)

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