Fall Prevention Among People With Spinal Cord Injury and Multiple Sclerosis Who Use Wheelchairs and Scooters

May 6, 2026 updated by: Laura Rice, University of Illinois at Urbana-Champaign

Development and Validation of a mHealth Fall Management Program - Phase III

The research team is conducting a study to determine if a fall prevention program designed specifically for people who use wheelchairs and scooters can help people better prevent and manage falls compared to the standard of care.

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 other group will receive fall prevention information from a well-known program developed by the Centers for Disease Control and Prevention (CDC), called STEADI, which stands for Stopping Elderly Accidents, Deaths, and Injuries.

This study includes adults living with Spinal Cord Injury (SCI) or Multiple Sclerosis (MS) who use a wheelchair or scooter every day. The research team aims to determine which approach is more effective in reducing falls and improving confidence in performing daily activities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

People living with SCI or MS who use wheelchairs and scooters (WC/S) full time often experience falls. In fact, 7 out of 10 report falling at least once every 6 to 12 months. These falls can lead to serious injuries and emotional distress, such as concerns about falling (CaF). Although falls are common among this population, most fall prevention programs are designed for people who can walk. There are very few programs designed for people who use WC/S.

This study will test to see if a fall prevention and management program designed specifically for people who use WC/S does a better job at helping people learn how to prevent and manage falls compared to a program that is designed for older adults.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Disability Participation and Quality of Life (DPQOL) Laboratory
        • Principal Investigator:
          • Laura Rice, PhD, MPT, ATP
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years old or older.
  • History of Multiple Sclerosis (MS) or Spinal Cord Injury (SCI).
  • Able to transfer independently or with minimal to moderate assistance.
  • Unable to walk 25 feet or more
  • Have experienced at least 1 fall in the past three years.
  • Have a care partner to assist the participant when practicing physical skills.
  • Have access to a smartphone/iPad.
  • Have a stable internet connection.

Exclusion Criteria:

  • Multiple sclerosis exacerbation in the past 30 days, or are unable to remain in an upright position for an hour.
  • Impaired cognition (a score of 10 or above on the Short Blessed Test).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Individualized reduction of falls (iROLL) Group
iROLL group participants will be educated about fall prevention and management strategies using the individualized reduction of falls (iROLL) mobile application (app)
Procedure: Individualized reduction of falls (iROLL)
The iROLL program is a 6-week fall prevention and management program for people living with spinal cord injury (SCI) and multiple sclerosis (MS) who use wheelchairs and scooters. The program's overall goals are to reduce fall frequency, improve functional mobility skills, decrease fear of falling, increase quality of life, and increase community participation. It uses many active learning strategies such as: goal setting, journaling, small group discussions, practicing skills, and homework to apply content to one's daily life.
Active Comparator: Stopping Elderly Accidents, Deaths & Injuries (STEADI) Program Group
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.
Procedure: Stopping Elderly Accidents, Deaths & Injuries (STEADI)
The CDC's Stopping Elderly Accidents, Deaths & Injuries (STEADI) initiative is a coordinated approach to fall prevention for older adults. It focuses on helping healthcare providers implement clinical fall prevention strategies, including screening for fall risk, assessing modifiable risk factors, and intervening to reduce risk.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional Assessment of Currently Employed Technology Scale
Time Frame: Baseline

Assesses how individuals with disabilities utilize currently available and assistive technologies in their everyday lives across five functional domains (Home, Social, E-commerce, Health Care, Technical).

Subscale (Domain)

Scoring:

Each domain's subtotal ranges from 0 to 10. Higher scores indicate more frequent use of technology.

Interpretation categories:

0-2: Very Infrequent IT Use; 3-4: Infrequent IT Use; 5-6: Moderate IT Use; 7-8: Frequent IT Use; 9-10: Very Frequent IT Use

Total FACETS Score:

Ranges from 0 to 50 (sum of the five domain subtotals). Higher total scores = greater overall frequency of technology use.

Interpretation categories:

0-14: Very Infrequent IT Use; 15-24: Infrequent IT Use; 25-34: Moderate IT Use; 35-44: Frequent IT Use; 45-50: Very Frequent IT Use
Baseline
Fall Concerns Scale for Wheelchair and Scooter Users
Time Frame: Baseline, Post-Intervention (Week 6 and Week 14)
Measures fear of falling and fall-related self-efficacy in individuals who use wheelchairs or scooters. The Fall Concerns Scale for Wheelchair and Scooter Users consists of 16 items, each rated on a 4-point Likert scale (1 = "not at all concerned" to 4 = "very concerned"). The total score ranges from 16 to 64, with higher scores indicating greater fear of falling and lower fall-related self-efficacy.
Baseline, Post-Intervention (Week 6 and Week 14)
Falls Prevention Strategies Survey
Time Frame: Baseline, Post-Intervention (Week 6 and Week 14)
Captures the frequency and types of fall prevention behaviors or strategies participants use in their daily lives.
Baseline, Post-Intervention (Week 6 and Week 14)
The Fall Management Scale
Time Frame: Baseline, Post-Intervention (Week 6 and Week 14)
Assesses participant confidence and preparedness in managing fall-related scenarios (e.g., recovery techniques, communication, and safety). Total scores range from 0 to 64. Higher scores indicate greater use of fall management strategies (better outcome).
Baseline, Post-Intervention (Week 6 and Week 14)
Fall Prevention and Management Questionnaire
Time Frame: Baseline, Post-Intervention (Week 6 and Week 14)
A multi-dimensional tool that evaluates participants' knowledge, behaviors, and attitudes toward fall prevention and recovery.
Baseline, Post-Intervention (Week 6 and Week 14)
Community Participation Indicators Questionnaire
Time Frame: Baseline, Post-Intervention (Week 6 and Week 14)

A self-report 48-item objective that measures two distinct subsets:

1) Importance and meaning, and 2) Control over participation. This questionnaire assesses levels of community engagement, social interaction, and participation in everyday activities outside the home. Items are typically rated on a Likert scale and aggregated to produce subscale scores and a total participation score.

Higher scores indicate greater community participation.

Scores range between 0 and 1, where:

0 = no meaningful participation.

1 = full participation in all important activities
Baseline, Post-Intervention (Week 6 and Week 14)
Transfer Assessment Instrument Questionnaire
Time Frame: Baseline, Post-Intervention (Week 6 and Week 14)
Measures participants' safety, technique, and confidence when transferring between surfaces (e.g., wheelchair to bed).
Baseline, Post-Intervention (Week 6 and Week 14)
Wheelchair Skills Test - Questionnaire
Time Frame: Baseline, Post-Intervention (Week 6 and Week 14)
Self-reported version of the Wheelchair Skills Test assessing wheelchair handling and maneuvering capabilities.
Baseline, Post-Intervention (Week 6 and Week 14)
System Usability Scale
Time Frame: Post-Intervention (Week 6)

Evaluates participants' perceived usability of the iROLL-O+ mobile app - only for the intervention group.

The SUS consists of 10 items, each scored on a 5-point Likert scale (0-4). The total raw score is converted to a 0-100 scale.

Higher scores indicate better usability. A score of 68 is considered average usability; scores above 68 reflect above-average usability, while scores below 68 reflect below-average usability.
Post-Intervention (Week 6)
Usefulness, Satisfaction, and Ease of Use Questionnaire
Time Frame: Post-Intervention (Week 6)
Assesses perceived usefulness, satisfaction, and ease of use of a mobile app. - only for the intervention group
Post-Intervention (Week 6)
Mobile App Rating Scale
Time Frame: Post-Intervention (Week 6)

Evaluates mobile app quality, including engagement, functionality, aesthetics, and information content. - Only for the intervention group.

The uMARS contains 20 items across four objective quality subscales (Engagement, Functionality, Aesthetics, Information).

Each item is rated on a 5-point Likert scale (1-5). Subscale scores are averaged, and a total quality mean score can also be calculated.

Higher scores indicate higher app quality.
Post-Intervention (Week 6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Illinois at Urbana-Champaign

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Illinois at Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Harshal Mahajan, Ph.D., University of Illinois, Urbana-Champaign
  • Principal Investigator: Laura Rice, PhD, MPT, ATP, University of Illinois, Urbana-Champaign

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB25-0716
  • 90DPHF0010 (Other Grant/Funding Number: NIDILRR)
  • 862958 (Other Grant/Funding Number: Craig H. Neilsen Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After completion of the study, an IRB-approved research team member (research assistant) will create a copy of the original data. All the identifiable information will be redacted from both online surveys and interview transcripts and unique codes will be assigned to each participant data. The identifiable data will be saved separately in a secure UIUC Box folder and only the de-identified data will be submitted to a data repository (Inter-university Consortium for Political and Social Research - ICPSR).

IPD Sharing Time Frame

Start date: after completion of the study; End date: NA

IPD Sharing Access Criteria

The data will be retrieved through the ICPSR platform, which provides secure access to the research datasets. Access is limited to individuals affiliated with ICPSR member institutions or those who obtain direct permission/licensing through ICPSR.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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