Pilot Study of Free From Falls Program in Multiple Sclerosis

Study Overview
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Brief Summary
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This pilot study will compare how often people with multiple sclerosis (MS) fall before participating in the Free From Falls (FFF) educational program, during the program, and for 8 weeks after the program. The protocol will also evaluate the accuracy, efficiency and convenience of an email survey to count how often people fall.

Detailed Description
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This pilot study will recruit people with MS who report falling at least twice in the previous 2 months to participate in the FFF program. All subjects will record their falls and injurious falls on a daily basis for at least 3 weeks before the program, during the program and for 8 weeks after the program. The program will consist of a weekly 2 hour session. One hour of the session will be educational and one hour of the program will involve exercise. The outcome of this study will be change in fall rate between the periods before, during and after the program.

Official Title
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Pilot Study on the Effect of the Free From Falls Program on Falls in People With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Educational intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: MS of any type Age 18 years or older Able to walk at least 100 meters with intermittent or unilateral constant assistance (cane, crutch or braces) with or without resting Self-reported history of 2 or more falls in the previous 2 months Clinically stable MS with no relapses within 30 days Willing to provide informed consent Fluent in written and spoken English. Daily access to email and willing to respond to a daily email questionnaire Exclusion Criteria: Serious psychiatric or medical conditions that would preclude reliable participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: education<br>Educational intervention | Behavioral: Educational intervention<br>* This is an 8-week comprehensive fall prevention exercise and education program, with one 2-hour session each week, for people with MS, adapted from a similar program for older adults.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fall frequency per month (30 days) | The change in fall frequency between the wait period before the FFF program begins and 8 weeks after the program has ended. | difference between the wait period before the 8 week FFF program and the 8 weeks after the end of the 8 week FFF program | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between paper and electronic fall calendars |  | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Accidental falls, Multiple Sclerosis, Education, Exercise, Postural balance