Comprehensive Fall Prevention and Detection in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— FFF  

Official title:

Comprehensive Fall Prevention and Detection in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583386
• Other study ID #: 3516
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: October 2019

Study information

• Verified date: March 2020
• Source: Portland VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine whether an exercise and educational classroom program can help reduce falls in people with Multiple Sclerosis who fall frequently.

Description:

The investigators will recruit 94 people with Multiple Sclerosis, who report having fallen at least twice in the previous 2 months. Participants will be randomized to be placed in either a group that receives classroom training during the study, or into a wait-listed control group that will be offered the classroom training after their participation in the study is completed. All participants will receive mobility and quality of life assessments at baseline, 9 weeks, 5 months, and 8 months. All participants will be asked to record any falls they have on falls calendars.

In addition, 30 participants will be randomized to wear electronic fall detectors on their bodies for the duration of the study. These detectors will record when and where falls occur, and this data will be compared with the participants' self-reported falls as recorded on the falls calendars.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Multiple Sclerosis of any type,

• self-reported history of 2 or more falls in the previous 2 months,

• Expanded Disability Status Scale of = 6.0 (i.e. able to walk at least 100 meters with or without a walking aid),

• be willing and intellectually able to understand and to sign an informed consent, and to adhere to protocol requirements,

• have sufficient motor function to complete a written daily record of falls for 8 months,

• be community dwelling.

Exclusion Criteria:

• have a self-reported musculoskeletal or neurological condition other than MS that is known to affect balance or gait and is associated with falls, such as a lower-extremity joint replacement within the past year, peripheral neuropathy, vestibular disorder, alcoholism, stroke, or seizures.

• be unable to follow directions in English,

• have unhealed bone fractures or other condition that may put them at risk of injury during balance training and assessments,

• blind (visual acuity corrected worse than 20/200),

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Free From Falls fall prevention program
Eight-week education and exercise program, intended to reduce falls in people with Multiple Sclerosis.

Other:
• Electronic Fall Detector
30 participants will be randomly selected to wear an electronic fall detector during the first 10 weeks of study participation. This fall detector will automatically record any falls occurring while worn.

Locations

Country	Name	City	State
United States	VA Portland Health Care System	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Portland VA Medical Center	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months	Paper fall calendars	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Primary	Change from Baseline in Balance Confidence	Activities-specific Balance Confidence questionnaire	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Primary	Change from Baseline in Satisfaction with Participation in Social Roles	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Satisfaction with Participation in Social Roles	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Primary	Change from Baseline in Ability to Participate in Social Roles and Activities	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 2.0 - Ability to Participate in Social Roles and Activities	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Primary	Change from Baseline in Quality of Life	Multiple Sclerosis Impact Scale-29	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Primary	Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars	The Mobile RF Fall Detection System automatically records falls per day experienced by the wearer. The results obtained by the fall detector will be tested for accuracy against the self-reported falls reported on paper fall calendars, in which participants manually record falls per day on a paper log.	8 weeks
Secondary	Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months	Timed Up and Go	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Secondary	Change from Baseline in Mobility and Balance (FSST score) at Completion of Program and the Following Six Months	Four Square Step Test	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Secondary	Change from Baseline in Level of Physical Activity at Completion of Program and the Following Six Months	International Physical Activity Questionnaire, short form	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months from baseline), 6 months after program completion (9 weeks + 6 months + baseline)
Secondary	Change from Baseline in Fall Prevention Strategy at Completion of Program and the Following Six Months	Fall Prevention Strategy Survey	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Secondary	Change from Baseline in Fatigue at Completion of Program and the Following Six Months	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Fatigue	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Secondary	Change from Baseline in Mobility at Completion of Program and the Following Six Months	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.2 - Physical Function - Mobility	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Secondary	Change from Baseline in Psychosocial Function at Completion of Program and the Following Six Months	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Psychosocial Illness Impact - Positive	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)
Secondary	Change from Baseline in Knowledge and Confidence Regarding Fall Prevention at Completion of Program and the Following Six Months	Fall Prevention Knowledge and Confidence Questionnaire	At baseline, at program completion (9 weeks), 3 months after program completion (9 weeks + 3 months), 6 months after program completion (9 weeks + 6 months)