Fall Risk Reduction in Multiple Sclerosis (FIRMS)
FIRMS
1 other identifier
interventional
100
1 country
1
Brief Summary
This study looks to see the effects of a home based exercise program on falls in people with MS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Dec 2014
Typical duration for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedAugust 26, 2015
August 1, 2015
3.1 years
November 23, 2014
August 25, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Chagne in Fall Risk
The primary outcome measure of this investigation is physiological fall risk. Physiological fall risk will be determined by the short form of the physiological profile assessment (PPA). The PPA is a validated tool to assess physiological function related to fall risk by combining measures of vision, proprioception, lower-limb strength, postural sway, and cognitive function. It is predictive of future fall risk in persons with MS. The PPA provides a fall risk score that is based on the quantification of key physiological markers (e.g. vision, leg strength, proprioception, balance, cognition, etc) and comparison of those markers to age and gender matched normative data. The PPA provides a therapeutically relevant prognostic predictor of falls and this makes it an ideal outcome measure of investigations evaluating fall prevention strategies.
1 year
Secondary Outcomes (1)
Identification of Fall Risk Factors
1 year
Study Arms (2)
Education
OTHERIn the second phase, participants will partake in an instructional class relating to gait, balance, and falls.
Exercise
OTHERIn the second phase,participants will partake in an exercise course relating to gait, balance, and falls.
Interventions
Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.
Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.
Eligibility Criteria
You may qualify if:
- Ability to walk 25 feet with or without aid
- Relapse free in the last 30 days
- Being ≥ 50 years of age
- Having fallen at least once in the past year
- Physician approval to engage in light physical activity
- Willingness and ability to attend the training sessions and testing sessions.
You may not qualify if:
- We will exclude all individuals with risk factors contra-indicative for undertaking strenuous exercise.
- During the initial phone contact with the project coordinator, participants will verbally respond to a health history questionnaire.
- Those individuals who are asymptomatic and meet no more than one risk factor threshold including family history of coronary heart disease, hypertension, high cholesterol, diabetes, obesity, and sedentary lifestyle will be considered at low risk and included for participation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Motor control research lab
Urbana, Illinois, 61801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob J Sosnoff, PhD
Motor Control Lab, University of Illinois
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2014
First Posted
December 11, 2014
Study Start
December 1, 2014
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
August 26, 2015
Record last verified: 2015-08