Comprehensive Fall Prevention and Detection in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars
研究概览
简要总结
The purpose of this study is to examine whether an exercise and educational classroom program can help reduce falls in people with Multiple Sclerosis who fall frequently.
详细描述
The investigators will recruit 94 people with Multiple Sclerosis, who report having fallen at least twice in the previous 2 months. Participants will be randomized to be placed in either a group that receives classroom training during the study, or into a wait-listed control group that will be offered the classroom training after their participation in the study is completed. All participants will receive mobility and quality of life assessments at baseline, 9 weeks, 5 months, and 8 months. All participants will be asked to record any falls they have on falls calendars.
In addition, 30 participants will be randomized to wear electronic fall detectors on their bodies for the duration of the study. These detectors will record when and where falls occur, and this data will be compared with the participants' self-reported falls as recorded on the falls calendars.
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
- 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
- •Multiple Sclerosis of any type,
- •self-reported history of 2 or more falls in the previous 2 months,
- •Expanded Disability Status Scale of ≤ 6.0 (i.e. able to walk at least 100 meters with or without a walking aid),
- •be willing and intellectually able to understand and to sign an informed consent, and to adhere to protocol requirements,
- •have sufficient motor function to complete a written daily record of falls for 8 months,
- •be community dwelling.
排除标准
- •have a self-reported musculoskeletal or neurological condition other than MS that is known to affect balance or gait and is associated with falls, such as a lower-extremity joint replacement within the past year, peripheral neuropathy, vestibular disorder, alcoholism, stroke, or seizures.
- •be unable to follow directions in English,
- •have unhealed bone fractures or other condition that may put them at risk of injury during balance training and assessments,
- •blind (visual acuity corrected worse than 20/200),
- •serious psychiatric or medical conditions that would preclude reliable participation in the study.
研究组 & 干预措施
Free From Falls training group
Subjects randomized to this group will receive an 8 week exercise and educational program on fall prevention (Free From Falls fall prevention program). They will have mobility and quality of life assessments taken at baseline, after the training program has been completed, and 3 and 6 months later. During this time, their falls will be recorded monthly using prospective falls calendars.
干预措施: Free From Falls fall prevention program (Behavioral)
Wait-list control group
Subjects in this group will participate in the same mobility and quality of life assessments and completion of the falls calendars, but will receive no training classes during this time. These subjects will have the opportunity to receive the class sessions when all assessment visits have been completed.
FFF training group w/ Fall Detector
Subjects randomized to this group will receive an 8 week exercise and educational program on fall prevention (Free From Falls fall prevention program). They will have mobility and quality of life assessments taken at baseline, after the training program has been completed, and 3 and 6 months later. During this time, their falls will be recorded monthly using prospective falls calendars.
In addition, this group will be asked to wear electronic fall detectors on their bodies for the first 10 weeks of their participation in the study.
干预措施: Free From Falls fall prevention program (Behavioral)
FFF training group w/ Fall Detector
Subjects randomized to this group will receive an 8 week exercise and educational program on fall prevention (Free From Falls fall prevention program). They will have mobility and quality of life assessments taken at baseline, after the training program has been completed, and 3 and 6 months later. During this time, their falls will be recorded monthly using prospective falls calendars.
In addition, this group will be asked to wear electronic fall detectors on their bodies for the first 10 weeks of their participation in the study.
干预措施: Electronic Fall Detector (Other)
Wait-list control w/ Fall Detector
Subjects in this group will participate in the same mobility and quality of life assessments and completion of the falls calendars, but will receive no training classes during this time. These subjects will have the opportunity to receive the class sessions when all assessment visits have been completed.
In addition, this group will be asked to wear electronic fall detectors on their bodies for the first 10 weeks of their participation in the study.
干预措施: Electronic Fall Detector (Other)
结局指标
主要结局
Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars
时间窗: 8 weeks
The Mobile RF Fall Detection System automatically records falls per day experienced by the wearer. The results obtained by the fall detector will be tested for accuracy against the self-reported falls reported on paper fall calendars, in which participants manually record falls per day on a paper log.
Change from Baseline in Balance Confidence
时间窗: At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Activities-specific Balance Confidence questionnaire
Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months
时间窗: At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Paper fall calendars
Change from Baseline in Satisfaction with Participation in Social Roles
时间窗: At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Satisfaction with Participation in Social Roles
Change from Baseline in Ability to Participate in Social Roles and Activities
时间窗: At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 2.0 - Ability to Participate in Social Roles and Activities
Change from Baseline in Quality of Life
时间窗: At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Multiple Sclerosis Impact Scale-29
次要结局
- Change from Baseline in Psychosocial Function at Completion of Program and the Following Six Months(At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months))
- Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months(At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months))
- Change from Baseline in Level of Physical Activity at Completion of Program and the Following Six Months(At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months from baseline), 6 months after program completion (9 weeks + 6 months + baseline))
- Change from Baseline in Fall Prevention Strategy at Completion of Program and the Following Six Months(At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months))
- Change from Baseline in Mobility at Completion of Program and the Following Six Months(At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months))
- Change from Baseline in Fatigue at Completion of Program and the Following Six Months(At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months))
- Change from Baseline in Knowledge and Confidence Regarding Fall Prevention at Completion of Program and the Following Six Months(At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months))
- Change from Baseline in Mobility and Balance (FSST score) at Completion of Program and the Following Six Months(At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months))
研究者
Michelle H. Cameron, MD, PT, MCR
Neurologist
Portland VA Medical Center