Comprehensive Fall Prevention and Detection in Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT02583386

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Free From Falls fall prevention program
  • Electronic Fall Detector

What it measured

Main measures

  • Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months

    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)

    Walking and mobility
  • Change from Baseline in Balance Confidence

    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)

    Walking and mobility
  • Change from Baseline in Satisfaction with Participation in Social Roles

    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)

    Quality of life (reported by participants)
  • Change from Baseline in Ability to Participate in Social Roles and Activities

    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)

    Quality of life (reported by participants)
  • Change from Baseline in Quality of Life

    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)

    Quality of life (reported by participants)
  • Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars

    8 weeks

    Walking and mobility

Other measures (8)

  • Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months

    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)

    Walking and mobility
  • Change from Baseline in Mobility and Balance (FSST score) at Completion of Program and the Following Six Months

    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)

    Walking and mobility
  • Change from Baseline in Level of Physical Activity at Completion of Program and the Following Six Months

    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)

    Physical function
  • Change from Baseline in Fall Prevention Strategy at Completion of Program and the Following Six Months

    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)

    Walking and mobility
  • Change from Baseline in Fatigue at Completion of Program and the Following Six Months

    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)

    FatigueQuality of life (reported by participants)
  • Change from Baseline in Mobility at Completion of Program and the Following Six Months

    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)

    Walking and mobilityQuality of life (reported by participants)
  • Change from Baseline in Psychosocial Function at Completion of Program and the Following Six Months

    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)

    Quality of life (reported by participants)
  • Change from Baseline in Knowledge and Confidence Regarding Fall Prevention at Completion of Program and the Following Six Months

    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)

    Walking and mobility

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Apr 2016

    2. Main results due

      Oct 2019

    3. Finished

      Oct 2019

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