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OpenTrials
Completed

NCT Number: NCT01956227

Fall Risk Reduction in Multiple Sclerosis: Exercise Versus Behavior

Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear. The purpose of this investigation is to determine whether exercise based or educational based interventions are more suited for fall prevention in older adults with MS.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Illinois UC

Urbana, Illinois, 61802, United States

About this study

Falls are a serious health concern for persons with multiple sclerosis (MS). Over 50% of persons with MS suffer a fall over a 6-month periodwith the majority of falls resulting in medical attention for injuries (i.e., lacerations, bone fractures, & head injuries). The effects of a fall are often compounded as it can lead to activity curtailment, physiological deconditioning, and institutionalization. Despite the importance of falls in persons with MS, the appropriate prevention strategies (i.e. rehabilitation approaches) are not clear.

It is well known that causes of falls are multifactorial with over 400 risk factors identified. However, it is believed that these factors can be divided into two main classes: intrinsic (e.g. physiological factors) and extrinsic factors. For instance balance dysfunction, spasticity and muscle weakness are physiological risk factors for falls in MS . Behavioral fall risk factors in MS include choosing appropriate footwear, lighting and utilizing appropriate assistive device. There is evidence that both types of risk factors can be minimized with appropriately designed interventions in persons with MS and have been shown to reduce fall risk and incidence in other clinical populations. This has led to calls for the combination of exercise training program that targets specific, modifiable physiological risk factors and educational interventions targeting modifiable behavioral risk factors in persons with MS. However, there is minimal evidence that these interventions in isolation or combination actually reduce fall incidence or risk in persons with MS. This proposal seeks to determine the effectiveness of a combined exercise and educational rehabilitation strategy to prevent falls in persons with MS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Definite multiple sclerosis diagnosis
  • ambulatory
  • aged 50-75 years of age
  • fallen within 12 months

Exclusion criteria

  • non-ambulatory
  • outside age range
  • no fall history

Treatment and study plan

Home-Based Exercise

Behavioral

exercise to look at balance and lower limb strength record in diary

Education

Behavioral

sessions to discuss self-management ideas to modify risk of falling

Exercise plus Education

Behavioral

combination of exercise sessions with education sessions to modify fall risk

Primary outcomes

  1. Fall incidence

    Time frame: 3 months

Secondary outcomes

  1. Physiological Fall Risk

    Time frame: 3 Months

    Physiological fall risk will be determined by the short form of the Physiological Profile Assessment (PPA)(Lord, 2003). The PPA is a standardized test battery which assesses vision (edge contrast sensitivity), lower limb proprioception, strength (knee extension), postural sway, and cognitive function (simple hand reaction time). The outcome of each test will be combined to generate an overall fall risk score

  2. Mobility

    Time frame: 3 months

    Specific measures of walking speed, endurance, coordination and self-reported walking function scale will be employed to assess overall mobility of each person. Walking speed was quantified with the Timed 25-Foot Walk (T25W), walking endurance was assessed with the 6-Minute Walk (6MW), and functional mobility was quantified with the Timed Up and Go (TUG) . The Multiple Sclerosis Walking Scale-12 (MSWS-12) will be used as a self-reported measure of walking impairment.

  3. Balance

    Time frame: 3 Months

    To assess balance (e.g. postural control), we conducted a clinical assessment To measure balance the Berg Balance Scale (BBS) and self-reports of balance confidence will be used. The BBS is a clinical assessment of balance. Scores on the BBS range from 0-56 with higher scores indicating greater balance. The Activities-Specific Balance Confidence (ABC) scale was used as a measure of balance confidence.

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Registry information

Acronym: FARMS-2

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2013
Registry last updated
Nov 25, 2014

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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