A Randomized Controlled Trial of a Multicomponent Walking Aid Program for People With MS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Change from Baseline in Self-Reported Falls at 8 months
研究概览
简要总结
This is a randomized controlled trial of the Assistive Device Selection, Training, and Education Program (ADSTEP). ADSTEP is a training program of six weekly one-on-one sessions with a physical therapist intended to reduce falls among people who use a hand-held walking aid, such as a cane or a walker. ADSTEP focuses on training in the use of the walking aid, and includes gait evaluation, walking aid selection and fitting, and progressive task-oriented training with the walking aid.
Participants will be randomized to receive ADSTEP or a waitlist control intervention; those in the control condition will receive National MS Society brochures on fall prevention and walking aid selection, and a letter will be sent informing their care provider that the subject reports falling. All subjects will complete an assessment visit at baseline, and follow-up assessments at about 8 weeks and about 6 months after that. Subjects will complete paper questionnaires of patient reported outcomes (PROs), a modified Functional Gait Assessment / Dynamic Gait Index, and will track fall sustained over their participation in the study using monthly paper fall calendars. At the end of study participation, all subjects in the control group will be offered the opportunity to receive ADSTEP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •A definite diagnosis of MS of any type;
- •18 years of age or older;
- •Self-reported history of at least one fall in the previous year;
- •Ability to walk at least 25 feet with or without an assistive device;
- •Intermittent or constant unilateral or bilateral assistance required to walk;
- •No MS exacerbations for the past 30 days;
- •Willingness to complete a written daily record of falls for about 8 months.
排除标准
- •Currently receiving physical therapy, or having any plans to receive physical therapy in the upcoming 8 months (duration of study participation);
- •Serious psychiatric or medical conditions that would preclude reliable participation in the study (e.g. dementia, deafness, blindness);
- •Inability to follow directions in English.
研究组 & 干预措施
training
The subjects receive the ADSTEP intervention
干预措施: ADSTEP (Behavioral)
waitlist
These subjects receive two brochures on fall prevention and walking aid selection, and a letter is sent to their care provider informing them that the subject has reported falling. Subjects in this group will be offered the ADSTEP intervention once their study participation is complete.
结局指标
主要结局
Change from Baseline in Self-Reported Falls at 8 months
时间窗: daily for 8 months
Paper Fall Calendars
次要结局
- Change from Baseline in Functional Gait Assessment / Dynamic Gait Index(At baseline, 8 weeks, and 8 months)
研究者
Michelle Cameron
Neurologist
Oregon Health and Science University