NCT01829776

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

November 4, 2014

Status Verified

November 1, 2014

Enrollment Period

1.4 years

First QC Date

April 9, 2013

Last Update Submit

November 3, 2014

Conditions

Multiple Sclerosis

Keywords

Accidental fallsMultiple SclerosisEducationExercisePostural balance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Relationship between paper and electronic fall calendars

    5 months

Study Arms (1)

education

EXPERIMENTAL

Educational intervention

Behavioral: Educational intervention

Interventions

Educational interventionBEHAVIORAL

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.

education

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Serious psychiatric or medical conditions that would preclude reliable participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University and Portland VA Medical Center

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Michelle H Cameron, MD, PT

    Oregon Health & Science University, Portland VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurologist, Assistant Professor

Study Record Dates

First Submitted

April 9, 2013

First Posted

April 11, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

November 4, 2014

Record last verified: 2014-11

Locations

US(1)