Comprehensive Fall Prevention and Detection in Multiple Sclerosis

NCT02583386 | Completed

• 1 other identifier: 3516
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

mobility; falls; fall prevention; gait and balance; automatic fall detector

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months

  Paper fall calendars

  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 Balance Confidence

  Activities-specific Balance Confidence questionnaire

  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 Satisfaction with Participation in Social Roles

  Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Satisfaction with Participation in Social Roles

  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 Ability to Participate in Social Roles and Activities

  Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 2.0 - Ability to Participate in Social Roles and Activities

  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 Quality of Life

  Multiple Sclerosis Impact Scale-29

  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)

• Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars

  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.

  8 weeks

Secondary Outcomes (8)

• 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 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)

• 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 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)

Study Arms (4)

Free From Falls training group

ACTIVE COMPARATOR

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.

Behavioral: Free From Falls fall prevention program

Wait-list control group

NO INTERVENTION

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

ACTIVE COMPARATOR

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.

Behavioral: Free From Falls fall prevention program; Other: Electronic Fall Detector

Wait-list control w/ Fall Detector

OTHER

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.

Other: Electronic Fall Detector

Interventions

Free From Falls fall prevention program BEHAVIORAL

Eight-week education and exercise program, intended to reduce falls in people with Multiple Sclerosis.

FFF training group w/ Fall Detector; Free From Falls training group

Electronic Fall Detector OTHER

30 participants will be randomly selected to wear an electronic fall detector during the first 10 weeks of study participation. This fall detector will automatically record any falls occurring while worn.

FFF training group w/ Fall Detector; Wait-list control w/ Fall Detector

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Portland VA Medical Center: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 34562766 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michelle H. Cameron, MD, PT, MCR

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 22, 2015
• Study Start: April 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: March 11, 2021

Record last verified: 2020-03

Locations

US (1)