跳至主要内容
临床试验/NCT03705364
NCT03705364Unknown不适用

Validation of a Fall Prevention Program Among Non-Ambulatory Wheeled Mobility Device Users With Multiple Sclerosis

University of Illinois at Urbana-Champaign3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
3
主要终点
Reduction in fall incidence

研究概览

简要总结

A research study to examine the effectiveness of a fall management program to prevent falls and develop fall recovery strategies for wheeled mobility device users living with Multiple Sclerosis.

详细描述

Falls are a serious concern for wheelchair and scooter users with Multiple Sclerosis (MS). Approximately 75% of the population reports at least one fall in a 6-month period and nearly half report frequent falls. Falls can result in physical injuries and contribute to activity curtailment. Despite the negative consequences, limited evidenced-based fall prevention programs designed specifically for wheelchair and scooter users with MS exist.

Recognizing the threat falls pose to health and well-being and the dearth of fall prevention programs, the purpose of this study to perform a structured process evaluation and examine the feasibility and efficacy of a community-based intervention specifically designed to reduce fall incidence among wheelchair and scooter users with MS. Secondary aims of the intervention are to improve functional mobility skills associated with fall risk (e.g. transfer and wheelchair skills, balance), increase knowledge of fall risk factors, decrease fear of falling and enhance quality of life and community participation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

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 Multiple Sclerosis
  • •>18 years old
  • •Main form of mobility is via a wheeled mobility device (Patient Determined Disease Steps Level 7)
  • •Self reported ability to transfer with moderate assistance or less
  • •Self-reported fall history (at least 1 fall/12 months)

排除标准

  • •MS exacerbation in the past 30 days
  • •Received a score of 10 or above to the Short Blessed Test (attached)
  • •Inability to sit upright for at least 1 hour.

研究组 & 干预措施

Wait List Control Group

No Intervention

Wait list control group

Fall Management program

Experimental

Intervention arm

干预措施: Fall Management program (Other)

结局指标

主要结局

Reduction in fall incidence

时间窗: 44 weeks

Fall Diary; Construct: to report and track the number of falls experienced; Less number of falls indicates better outcome.

次要结局

  • Prevention of Fall(44 weeks)
  • Prevention and Management of Fall(44 weeks)
  • Management of Fall(44 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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