Pilot Study of Free From Falls Program in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— FFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01829776
• Other study ID #: 9257
• Status: Completed
• Phase: N/A
• First received: April 9, 2013
• Last updated: November 3, 2014
• Start date: April 2013
• Est. completion date: September 2014

Study information

• Verified date: November 2014
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Educational intervention
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.

Locations

Country	Name	City	State
United States	Oregon Health and Science University and Portland VA Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Relationship between paper and electronic fall calendars		5 months	No