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临床试验/NCT05144113
NCT05144113已完成不适用

FES-Rowing: Preventing the Secondary Conditions of Paralysis Through Vigorous Exercise

Spaulding Rehabilitation Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年3月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI)

研究概览

简要总结

Over the past ten years, the Cardiovascular Research Laboratory at Spaulding has refined a unique form of exercise for those with spinal cord injuries (SCI). Functional Electrical Stimulation Row Training (FESRT) couples volitional arm and electrically controlled leg exercise, resulting in the benefits of large muscle mass exercise. Despite the success of the FES-rowing Program at Spaulding, FES-rowing systems have not yet evolved beyond research prototypes, and ours is the only program in the US where FES-rowing is available. A new design is critically needed to enable people with paralysis to participate in FES rowing in their own homes, which we believe will maximize both the health and commercial impacts of FES-rowing.

详细描述

The purpose of this observational study is to gain insights into user needs, and market perception of physical activity and FES-rowing to further develop a new, home-based FES-rowing system that meets the needs of people with paralysis. We will enroll a total of 20 subjects, male and female, 18 years and older with lower-limb paralysis who use a wheelchair as their primary means of mobility. Ten subjects will be current FES-rowing participants (especially those doing FES-rowing at home) and 10 subjects will be non-participants. To determine user needs we will survey prospective customers to discover their motivations, preferences and challenges pertaining to participation in physical activity in general and FES-rowing.

Questionnaires:

Barriers to Physical Activity Questionnaire for People with Mobility Impairments (BPAQ-MI): measures barriers to physical activity across the intrapersonal and interpersonal domains.

Physical Activity and Disability Survey (PADS): measures physical activity for people with chronic neurological conditions.

Demographic and Mobility Questionnaire: Important information to inform on user and design needs and potential market for at home FES-row system.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • 未提供

排除标准

  • Under 18 years of age
  • no lower-limb paralysis
  • People who do not use a wheelchair as their primary means of mobility

结局指标

主要结局

Barriers to Physical Activity Questionnaire for People With Mobility Impairments (BPAQ-MI)

时间窗: baseline

measures barriers to physical activity across the intrapersonal (health and beliefs/attitudes) and interpersonal (friends and family) domains. Minimum score is 0 (not a barrier at all), and larger scores up to a maximum domain score of 5 indicate bigger barriers to physical activity.

Demographic and Mobility Questionnaire: Clinical Diagnosis Causing Paralysis

时间窗: baseline

important information to inform on user and design needs and potential market for at home FES-row system.

Demographic and Mobility Questionnaire: Type of Wheelchair Primarily Used

时间窗: baseline

important information to inform on user and design needs and potential market for at home FES-row system.

Quebec User Evaluation of Satisfaction With Assistive Technology (QUEST 2.0)

时间窗: baseline

(FES-row participants only): measures satisfaction with current FES-row system used in the ExPD Program. Minimum score is 0 (least satisfied), maximum score is 5 (most satisfied).

Barriers to Physical Activity and Disability Survey (BPAD-S)

时间窗: baseline

measures barriers to physical activity for people with chronic neurological conditions by asking each subject to endorse/deny (i.e., yes/no) experiencing 19 unique barriers. Number of subject endorsements ("yes") of each barrier per group (Current FES-Row vs. Non FES-Row) are reported. Thus, the sum of the rows will not equal the number of participants analyzed, since subject could endorse experiencing up to 19 barriers.

次要结局

未报告次要终点

研究者

发起方
Spaulding Rehabilitation Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

J. Andrew Taylor

Associate Professor

Spaulding Rehabilitation Hospital

研究点 (1)

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