Back to resultsPilot Study of Free From Falls Program in Multiple Sclerosis (FFF)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Sclerosis focused on measuring Accidental falls, Multiple Sclerosis, Education, Exercise, Postural balance
Eligibility Criteria
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.
Sites / Locations
- Oregon Health and Science University and Portland VA Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
education
Arm Description
Educational intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Relationship between paper and electronic fall calendars
Full Information
NCT ID
NCT01829776
First Posted
April 9, 2013
Last Updated
November 3, 2014
Sponsor
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT01829776
Brief Title
Pilot Study of Free From Falls Program in Multiple Sclerosis
Acronym
FFF
Official Title
Pilot Study on the Effect of the Free From Falls Program on Falls in People With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Accidental falls, Multiple Sclerosis, Education, Exercise, Postural balance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
education
Arm Type
Experimental
Arm Description
Educational intervention
Intervention Type
Behavioral
Intervention Name(s)
Educational intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in fall frequency per month (30 days)
Description
The change in fall frequency between the wait period before the FFF program begins and 8 weeks after the program has ended.
Time Frame
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 Measure Information:
Title
Relationship between paper and electronic fall calendars
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle H Cameron, MD, PT
Organizational Affiliation
Oregon Health & Science University, Portland VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University and Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Free From Falls Program in Multiple Sclerosis
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