- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02583386
Comprehensive Fall Prevention and Detection in Multiple Sclerosis (FFF)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- VA Portland Health Care System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 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.
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Eight-week education and exercise program, intended to reduce falls in people with Multiple Sclerosis.
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No Intervention: 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.
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Active Comparator: 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. |
Eight-week education and exercise program, intended to reduce falls in people with Multiple Sclerosis.
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.
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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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Paper fall calendars
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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)
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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)
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Activities-specific Balance Confidence questionnaire
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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)
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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)
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Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Satisfaction with Participation in Social Roles
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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)
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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)
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Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 2.0 - Ability to Participate in Social Roles and Activities
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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)
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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)
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Multiple Sclerosis Impact Scale-29
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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)
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Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars
Time Frame: 8 weeks
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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.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Timed Up and Go
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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)
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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)
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Four Square Step Test
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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)
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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)
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International Physical Activity Questionnaire, short form
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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)
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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)
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Fall Prevention Strategy Survey
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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)
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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)
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Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Fatigue
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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)
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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)
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Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.2 - Physical Function - Mobility
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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)
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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)
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Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Psychosocial Illness Impact - Positive
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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)
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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)
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Fall Prevention Knowledge and Confidence Questionnaire
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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)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle H. Cameron, MD, PT, MCR, Portland VA Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3516
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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