Fall Prevention Among People With Spinal Cord Injury and Multiple Sclerosis Who Use Wheelchairs and Scooters
Development and Validation of a mHealth Fall Management Program - Phase III
3 other identifiers
interventional
120
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedFirst Posted
Study publicly available on registry
September 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
September 11, 2025
September 1, 2025
11 months
August 8, 2025
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Functional Assessment of Currently Employed Technology Scale
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
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
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
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
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
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
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
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
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
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
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)
Study Arms (2)
Individualized reduction of falls (iROLL) Group
EXPERIMENTALiROLL group participants will be educated about fall prevention and management strategies using the individualized reduction of falls (iROLL) mobile application (app)
Stopping Elderly Accidents, Deaths & Injuries (STEADI) Program Group
ACTIVE COMPARATORSTEADI 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Disability Participation and Quality of Life (DPQOL) Laboratory
Urbana, Illinois, 61801, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be blindly assigned to one of the groups to reduce bias.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor in the Department of Health and Kinesiology; Associate Head for Graduate Studies; Associate Director of the Center for Health, Aging, and Disability; Principal Investigator
Study Record Dates
First Submitted
August 8, 2025
First Posted
September 11, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- Start date: after completion of the study; End date: NA
- 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.
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).