Multiple SclerosisFFFNCT02583386
Comprehensive Fall Prevention and Detection in Multiple Sclerosis
A study testing Free From Falls fall prevention program and Electronic Fall Detector in people with Multiple Sclerosis, run by Portland VA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Free From Falls fall prevention program and Electronic Fall Detector
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Portland Health Care System
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Free From Falls fall prevention program, Electronic Fall Detector
- Keywords
- mobility, falls, fall prevention, gait and balance, automatic fall detector
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free From Falls fall prevention programBehavioural
Eight-week education and exercise program, intended to reduce falls in people with Multiple Sclerosis.
Electronic Fall DetectorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Electronic Fall Detector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months
Paper fall calendars
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 8 weeks
Secondary outcomes (8)
Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months
Timed Up and Go
Measured: 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
Four Square Step Test
Measured: 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
International Physical Activity Questionnaire, short form
Measured: 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
Fall Prevention Strategy Survey
Measured: 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
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Fatigue
Measured: 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
Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.2 - Physical Function - Mobility
Measured: 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 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
Measured: 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
Fall Prevention Knowledge and Confidence Questionnaire
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startApr 2016
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portland VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Michelle H. Cameron, MD, PT, MCR, Portland VA Medical Center
- Investigators
- Michelle H. Cameron, MD, PT, MCR, Principal investigator, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583386
- Sponsor's protocol ID
- 3516
- Acronym
- FFF
- Status last verified
- Mar 2020
- First submitted
- 19 Oct 2015
- Last updated
- 11 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34562766
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Fall Prevention and Detection in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02583386
- Acronym / sponsor ID
- FFF / 3516
- Conditions
- Multiple Sclerosis
- Keywords
- mobility, falls, fall prevention, gait and balance, automatic fall detector
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Portland VA Medical CenterUS federal agency
- Collaborators
- Oregon Health and Science University
- Study start
- Apr 2016
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Free From Falls training group | Active comparator | Behavioral: Free From Falls fall prevention programSubjects 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. |
| 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 | Behavioral: Free From Falls fall prevention program, Other: Electronic Fall DetectorSubjects 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. |
| Wait-list control w/ Fall Detector | Other | Other: Electronic Fall DetectorSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free From Falls fall prevention programEight-week education and exercise program, intended to reduce falls in people with Multiple Sclerosis. | Behavioural | FFF training group w/ Fall Detector, Free From Falls training group |
| Electronic Fall Detector30 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. | Other | FFF training group w/ Fall Detector, Wait-list control w/ Fall Detector |
Primary outcome
Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months
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)
Paper fall calendars
Change from Baseline in Balance Confidence
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)
Activities-specific Balance Confidence questionnaire
Change from Baseline in 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)
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
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)
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
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)
Multiple Sclerosis Impact Scale-29
Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars
Time frame: 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.
8 secondary outcomes
Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months
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)
Change from Baseline in Mobility and Balance (FSST score) at Completion of Program and the Following Six Months
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)
Change from Baseline in Level of Physical Activity at Completion of Program and the Following Six Months
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)
Change from Baseline in Fall Prevention Strategy at Completion of Program and the Following Six Months
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)
Change from Baseline in Fatigue at Completion of Program and the Following Six Months
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)
Change from Baseline in Mobility at Completion of Program and the Following Six Months
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)
Change from Baseline in Psychosocial Function at Completion of Program and the Following Six Months
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)
Change from Baseline in Knowledge and Confidence Regarding Fall Prevention at Completion of Program and the Following Six Months
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2021.
- Derived from this study: PubMed 34562766Hildebrand 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle H. Cameron, MD, PT, MCR principal investigator
Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free From Falls fall prevention program and Electronic Fall Detector in people with Multiple Sclerosis, run by Portland VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months (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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583386, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2021.