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Comprehensive Fall Prevention and Detection in Multiple Sclerosis (FFF)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Free From Falls fall prevention program
Electronic Fall Detector
Sponsored by
Portland VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring mobility, falls, fall prevention, gait and balance, automatic fall detector

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Portland Health Care System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Active Comparator

Other

Arm Label

Free From Falls training group

Wait-list control group

FFF training group w/ Fall Detector

Wait-list control w/ Fall Detector

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months
Paper fall calendars
Change from Baseline in Balance Confidence
Activities-specific Balance Confidence questionnaire
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
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
Change from Baseline in Quality of Life
Multiple Sclerosis Impact Scale-29
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.

Secondary Outcome Measures

Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months
Timed Up and Go
Change from Baseline in Mobility and Balance (FSST score) at Completion of Program and the Following Six Months
Four Square Step Test
Change from Baseline in Level of Physical Activity at Completion of Program and the Following Six Months
International Physical Activity Questionnaire, short form
Change from Baseline in Fall Prevention Strategy at Completion of Program and the Following Six Months
Fall Prevention Strategy Survey
Change from Baseline in Fatigue at Completion of Program and the Following Six Months
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Fatigue
Change from Baseline in Mobility at Completion of Program and the Following Six Months
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.2 - Physical Function - Mobility
Change from Baseline in Psychosocial Function at Completion of Program and the Following Six Months
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Psychosocial Illness Impact - Positive
Change from Baseline in Knowledge and Confidence Regarding Fall Prevention at Completion of Program and the Following Six Months
Fall Prevention Knowledge and Confidence Questionnaire

Full Information

First Posted
October 19, 2015
Last Updated
March 9, 2021
Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT02583386
Brief Title
Comprehensive Fall Prevention and Detection in Multiple Sclerosis
Acronym
FFF
Official Title
Comprehensive Fall Prevention and Detection in Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland VA Medical Center
Collaborators
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
mobility, falls, fall prevention, gait and balance, automatic fall detector

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Free From Falls training group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
FFF training group w/ Fall Detector
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wait-list control w/ Fall Detector
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Free From Falls fall prevention program
Intervention Description
Eight-week education and exercise program, intended to reduce falls in people with Multiple Sclerosis.
Intervention Type
Other
Intervention Name(s)
Electronic Fall Detector
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months
Description
Paper fall calendars
Time Frame
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)
Title
Change from Baseline in Balance Confidence
Description
Activities-specific Balance Confidence questionnaire
Time Frame
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)
Title
Change from Baseline in Satisfaction with Participation in Social Roles
Description
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Satisfaction with Participation in Social Roles
Time Frame
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)
Title
Change from Baseline in Ability to Participate in Social Roles and Activities
Description
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 2.0 - Ability to Participate in Social Roles and Activities
Time Frame
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)
Title
Change from Baseline in Quality of Life
Description
Multiple Sclerosis Impact Scale-29
Time Frame
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)
Title
Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months
Description
Timed Up and Go
Time Frame
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)
Title
Change from Baseline in Mobility and Balance (FSST score) at Completion of Program and the Following Six Months
Description
Four Square Step Test
Time Frame
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)
Title
Change from Baseline in Level of Physical Activity at Completion of Program and the Following Six Months
Description
International Physical Activity Questionnaire, short form
Time Frame
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)
Title
Change from Baseline in Fall Prevention Strategy at Completion of Program and the Following Six Months
Description
Fall Prevention Strategy Survey
Time Frame
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)
Title
Change from Baseline in Fatigue at Completion of Program and the Following Six Months
Description
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Fatigue
Time Frame
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)
Title
Change from Baseline in Mobility at Completion of Program and the Following Six Months
Description
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.2 - Physical Function - Mobility
Time Frame
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)
Title
Change from Baseline in Psychosocial Function at Completion of Program and the Following Six Months
Description
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Psychosocial Illness Impact - Positive
Time Frame
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)
Title
Change from Baseline in Knowledge and Confidence Regarding Fall Prevention at Completion of Program and the Following Six Months
Description
Fall Prevention Knowledge and Confidence Questionnaire
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle H. Cameron, MD, PT, MCR
Organizational Affiliation
Portland VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34562766
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.
Results Reference
derived

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Comprehensive Fall Prevention and Detection in Multiple Sclerosis

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