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Completed

NCT Number: NCT02583386

Comprehensive Fall Prevention and Detection in Multiple Sclerosis

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Portland Health Care System

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free From Falls fall prevention program

Behavioral

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

Electronic Fall Detector

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

Secondary outcomes

  1. 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)

    Timed Up and Go

  2. 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)

    Four Square Step Test

  3. 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)

    International Physical Activity Questionnaire, short form

  4. 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)

    Fall Prevention Strategy Survey

  5. 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)

    Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Fatigue

  6. 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)

    Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.2 - Physical Function - Mobility

  7. 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)

    Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Psychosocial Illness Impact - Positive

  8. 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)

    Fall Prevention Knowledge and Confidence Questionnaire

Sponsors and collaborators

Lead sponsor

Portland VA Medical Center

Fed

Collaborators

  • Oregon Health and Science University

Registry information

Acronym: FFF

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2015
Registry last updated
Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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