Clinical trial NCT02583386: Comprehensive Fall Prevention and Detection in Multiple Sclerosis
Official title: Comprehensive Fall Prevention and Detection in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: mobility
falls
fall prevention
gait and balance
automatic fall detector
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
Collaborators: name: Oregon Health and Science University
First posted: 2015-10-22
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months
timeFrame: 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)
measure: Change from Baseline in Balance Confidence
timeFrame: 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)
measure: Change from Baseline in Satisfaction with Participation in Social Roles
timeFrame: 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)
measure: Change from Baseline in Ability to Participate in Social Roles and Activities
timeFrame: 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)
measure: Change from Baseline in Quality of Life
timeFrame: 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)
measure: Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars
timeFrame: 8 weeks
Secondary outcomes:
measure: Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months
timeFrame: 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)
measure: Change from Baseline in Mobility and Balance (FSST score) at Completion of Program and the Following Six Months
timeFrame: 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)
measure: Change from Baseline in Level of Physical Activity at Completion of Program and the Following Six Months
timeFrame: 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)
measure: Change from Baseline in Fall Prevention Strategy at Completion of Program and the Following Six Months
timeFrame: 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)
measure: Change from Baseline in Fatigue at Completion of Program and the Following Six Months
timeFrame: 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)
measure: Change from Baseline in Mobility at Completion of Program and the Following Six Months
timeFrame: 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)
measure: Change from Baseline in Psychosocial Function at Completion of Program and the Following Six Months
timeFrame: 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)
measure: Change from Baseline in Knowledge and Confidence Regarding Fall Prevention at Completion of Program and the Following Six Months
timeFrame: 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)
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System
state: Oregon
Study officials:
affiliation: Portland VA Medical Center
name: Michelle H. Cameron, MD, PT, MCR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hildebrand A, Jacobs PG, Folsom JG, Mosquera-Lopez C, Wan E, Cameron MH. Comparing fall detection methods in people with multiple sclerosis: A prospective observational cohort study. Mult Scler Relat Disord. 2021 Nov;56:103270. doi: 10.1016/j.msard.2021.103270. Epub 2021 Sep 20.