Fall Prevention Program for Multiple Sclerosis

Overseen By Laura Rice, PhD, MPT, ATP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Urbana-Champaign

Disqualifiers: Recent MS exacerbation, impaired cognition

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to help people with Multiple Sclerosis (MS) or Spinal Cord Injury (SCI), who use wheelchairs or scooters, prevent falls. It compares two methods: one group uses the iROLL-O+ app with personalized fall prevention strategies, while the other receives information from the CDC's STEADI program, a fall prevention initiative. The goal is to determine which method more effectively reduces falls and boosts confidence in daily activities. Suitable participants have MS or SCI, require a wheelchair or scooter daily, and have fallen at least once in the past three years. Participants also need access to a smartphone or iPad and a stable internet connection.

As an unphased trial, this study provides a unique opportunity to contribute to innovative fall prevention strategies and enhance confidence in daily living.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the research team or your doctor.

What prior data suggests that this fall prevention program is safe for people with Multiple Sclerosis?

Research shows that the iROLL-O+ app has undergone safety testing in people with spinal cord injuries (SCI) and multiple sclerosis (MS) who use wheelchairs or scooters. Early results suggest that participants handle the program well. Past studies reported no major side effects or problems. The app aims to help prevent falls and manage them by offering personalized strategies and tools.

Since this study doesn't involve new drugs or invasive procedures, it presents fewer safety concerns. The focus is on using an app to provide helpful information and strategies, which typically carries fewer risks than drug trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these fall prevention programs for multiple sclerosis because they offer innovative approaches to reducing falls. The iROLL-O+ app is unique as it leverages mobile technology to provide personalized fall prevention strategies, empowering users to take charge of their own safety. Meanwhile, the STEADI program offers a comprehensive, proven framework from the CDC focusing on fall prevention and injury management, which could be adapted for people with multiple sclerosis. Together, these methods aim to enhance quality of life by proactively addressing fall risks in ways that current treatments may not fully cover.

What evidence suggests that this trial's fall prevention programs could be effective for people with Multiple Sclerosis or Spinal Cord Injury?

Research has shown that the iROLL-O+ app, which participants in this trial may use, might help people with multiple sclerosis (MS) or spinal cord injury (SCI) reduce their risk of falling. A previous study found that 69% of people with SCI who use wheelchairs or scooters fell at least once in a year, highlighting the need for effective prevention strategies. The iROLL-O+ app provides personalized tools and strategies, and early findings suggest it could better manage falls. Meanwhile, participants in another arm of this trial will use the CDC's STEADI program, which offers general fall prevention information but isn't specifically designed for wheelchair or scooter users. While both aim to prevent falls, the iROLL-O+'s customization may be more beneficial for those with specific mobility needs. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adults with Spinal Cord Injury or Multiple Sclerosis who use wheelchairs or scooters daily are eligible for this trial. It aims to help them prevent and manage falls better.

Inclusion Criteria

Have experienced at least 1 fall in the past three years

I have someone to help me with physical activities.

I can move around on my own or with some help.

Exclusion Criteria

Impaired cognition (a score of 10 or above on the Short Blessed Test)

I haven't had a multiple sclerosis flare-up in the last 30 days and can stay upright for an hour.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are educated about fall prevention and management strategies using either the iROLL-O+ app or the STEADI program

14 weeks

Baseline, Week 6, Week 14

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• iROLL-O+ app
• STEADI

Trial Overview The study compares two fall prevention approaches: the iROLL-O+ app, offering personalized tools and strategies, versus the STEADI program from the CDC providing standard care information.

How Is the Trial Designed?

Group I: Individualized reduction of falls (iROLL) Group Experimental Treatment 1 Intervention

iROLL group participants will be educated about fall prevention and management strategies using the individualized reduction of falls (iROLL) mobile application (app)

Group II: Stopping Elderly Accidents, Deaths & Injuries (STEADI) Program Group Active Control 1 Intervention

STEADI group participants will be educated about fall prevention and management strategies using Centers for Disease Control and Prevention entitled: Stopping Elderly Accidents, Deaths \& Injuries (STEADI) program.

Who Is Running the Clinical Trial?

University of Illinois at Urbana-Champaign

Lead Sponsor

Trials

203

Recruited

40,600+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07167680

Fall Prevention Among People With Spinal Cord Injury and ... This study will compare two groups of participants: One group will use the iROLL-O+ app, which offers personalized fall prevention tools and ...

2. dpql.hk.illinois.edu dpql.hk.illinois.edu/individualized-reduction-of-falls-intervention-program-iroll/

Individualized Reduction of Falls Intervention Program Previous studies have found that 69% of individuals living with SCI who use wheelchairs and scooters fall at least once in one year period and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36923574/

Online Delivery of the Individualized Reduction of Falls ... This study is the first to examine the preliminary efficacy of an online fall prevention and management intervention for people with MS who use a wheelchair or ...

4. iroll.hk.illinois.edu iroll.hk.illinois.edu/the-iroll-program/

iROLL-O+ The study will involve using the app and attending an online discussion with a small group of other people who use wheelchairs and scooters one time per week ...

5. withpower.com withpower.com/trial/phase-spinal-cord-injuries-8-2025-6ba1d

Fall Prevention Program for Multiple Sclerosis This study will compare two groups of participants:1. One group will use the iROLL-O+ app, which offers personalized fall prevention tools and strategies.2. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9791181/

A process evaluation of an on-line fall prevention and ... An online, group fall prevention, and management program specifically designed for community-based people living with multiple sclerosis (pwMS) who are full- ...

7. iroll.hk.illinois.edu iroll.hk.illinois.edu/files/2022/09/iROLL-Manual.pdf

D4_Combined_Revised Manual iROLL O_2-24-21_LR Investigation of the Feasibility of an Intervention to. Manage Fall Risk in Wheeled Mobility Device Users with Multiple Sclerosis. Int J MS. Care. 2018;20(3): ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10010107/

Online Delivery of the Individualized Reduction of Falls ... This study is the first to examine the preliminary efficacy of an online fall prevention and management intervention for people with MS who use a wheelchair or ...