Comprehensive Fall Prevention and Detection in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2019-10-31

Brief Summary

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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.

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Detailed Description

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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

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Free From Falls fall prevention program

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Free From Falls fall prevention program

Intervention Type BEHAVIORAL

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

Electronic Fall Detector

Intervention Type 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.

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.

Group Type OTHER

Electronic Fall Detector

Intervention Type 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.

Interventions

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Free From Falls fall prevention program

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

Intervention Type BEHAVIORAL

Electronic Fall Detector

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No