Multiple SclerosisFFFNCT01829776
Pilot Study of Free From Falls Program in Multiple Sclerosis
A study testing Educational intervention in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Serious psychiatric or medical conditions that would preclude reliable participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University and Portland VA Medical Center
Portland, Oregon, 97239
About this study
Official title: Pilot Study on the Effect of the Free From Falls Program on Falls in People With Multiple Sclerosis
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Educational intervention
- Keywords
- Accidental falls, Multiple Sclerosis, Education, Exercise, Postural balance
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| education | Experimental | Educational intervention Receives: Behavioral: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Cameron, Oregon Health and Science University
- Investigators
- Michelle H Cameron, MD, PT, Principal investigator, Oregon Health & Science University, Portland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829776
- Sponsor's protocol ID
- 9257
- Acronym
- FFF
- Status last verified
- Nov 2014
- First submitted
- 9 Apr 2013
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effect of the Free From Falls Program on Falls in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01829776
- Acronym / sponsor ID
- FFF / 9257
- Conditions
- Multiple Sclerosis
- Keywords
- Accidental falls, Multiple Sclerosis, Education, Exercise, Postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| education | Experimental | Behavioral: Educational interventionEducational intervention |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Serious psychiatric or medical conditions that would preclude reliable participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionThis 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. | Behavioural | education |
Primary outcome
Change in fall frequency per month (30 days)
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
The change in fall frequency between the wait period before the FFF program begins and 8 weeks after the program has ended.
1 secondary outcome
Relationship between paper and electronic fall calendars
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle H Cameron, MD, PT principal investigator
Oregon Health & Science University, Portland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Multiple Sclerosis, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fall frequency per month (30 days) (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2014.