Comprehensive Fall Prevention and Detection in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT02583386
• Lead Sponsor: Portland VA Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-10-19
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Study Start: 2016-04
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2020-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Accuracy and Impact of Fall Detection and Localization by the MobileRF Fall Detection System, Compared to Paper Fall Calendars	8 weeks	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.
Change from Baseline in Balance Confidence	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)	Activities-specific Balance Confidence questionnaire
Change from Baseline in Self-Reported Falls and Fall-Related Injuries at Completion of Program and the Following Six Months	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)	Paper fall calendars
Change from Baseline in 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)	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Satisfaction with Participation in Social Roles
Change from Baseline in 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)	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 2.0 - Ability to Participate in Social Roles and Activities
Change from Baseline in Quality of Life	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)	Multiple Sclerosis Impact Scale-29

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Psychosocial Function at Completion of Program and the Following Six Months	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)	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Psychosocial Illness Impact - Positive
Change from Baseline in Mobility and Balance (TUG score) at Completion of Program and the Following Six Months	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)	Timed Up and Go
Change from Baseline in Level of Physical Activity at Completion of Program and the Following Six Months	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)	International Physical Activity Questionnaire, short form
Change from Baseline in Fall Prevention Strategy at Completion of Program and the Following Six Months	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)	Fall Prevention Strategy Survey
Change from Baseline in Mobility at Completion of Program and the Following Six Months	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)	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.2 - Physical Function - Mobility
Change from Baseline in Fatigue at Completion of Program and the Following Six Months	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)	Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v. 1.0 - Fatigue
Change from Baseline in Knowledge and Confidence Regarding Fall Prevention at Completion of Program and the Following Six Months	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)	Fall Prevention Knowledge and Confidence Questionnaire
Change from Baseline in Mobility and Balance (FSST score) at Completion of Program and the Following Six Months	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)	Four Square Step Test

Trial Locations

Locations (1)

VA Portland Health Care System; 🇺🇸 Portland, Oregon, United States