Comprehensive Fall Prevention and Detection in Multiple Sclerosis (FFF)

Portland VA Medical Center

Status: Completed

Conditions: Multiple Sclerosis

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

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02583386

3516

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 4 patient groups

Free From Falls training group

Active Comparator group

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.

Treatment:

Behavioral: Free From Falls fall prevention program

Wait-list control group

No Intervention group

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.

FFF training group w/ Fall Detector

Active Comparator group

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.

Treatment:

Other: Electronic Fall Detector

Behavioral: Free From Falls fall prevention program

Wait-list control w/ Fall Detector

Other group

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.

Treatment:

Other: Electronic Fall Detector