Spinal Cord Injuries (SCI)NCT07167680
Fall Prevention Among People With Spinal Cord Injury and Multiple Sclerosis Who Use Wheelchairs and Scooters
A study testing Individualized reduction of falls (iROLL) and Stopping Elderly Accidents, Deaths & Injuries (STEADI) in people with Spinal Cord Injuries (SCI) and Multiple Sclerosis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries (SCI), Multiple Sclerosis
- What is being tested?
- Individualized reduction of falls (iROLL) and Stopping Elderly Accidents, Deaths & Injuries (STEADI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Disability Participation and Quality of Life (DPQOL) Laboratory
Urbana, Illinois, 61801
Laura Rice, PhD, MPT, ATP, 217-333-4650, dpqol-lab@illinois.edu
Laura Rice, PhD, MPT, ATP
About this study
Official title: 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:
Read more
- One group will use the iROLL-O+ app, which offers personalized fall prevention tools and strategies.
- 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.
Read the 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.
- Conditions
- Spinal Cord Injuries (SCI), Multiple Sclerosis
- Being tested
- Individualized reduction of falls (iROLL), Stopping Elderly Accidents, Deaths & Injuries (STEADI)
- Keywords
- wheelchair, fall prevention, mobile application, spinal cord injury, multiple sclerosis, education
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized reduction of falls (iROLL)Procedure or surgery
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.
Stopping Elderly Accidents, Deaths & Injuries (STEADI)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Individualized reduction of falls (iROLL) Group | Experimental | iROLL group participants will be educated about fall prevention and management strategies using the individualized reduction of falls (iROLL) mobile application (app) Receives: Procedure: Individualized reduction of falls (iROLL) |
| Stopping Elderly Accidents, Deaths & Injuries (STEADI) Program Group | Active comparator | 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. Receives: Procedure: Stopping Elderly Accidents, Deaths & Injuries (STEADI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, Post-Intervention (Week 6 and Week 14)
Community Participation Indicators Questionnaire
A self-report 48-item objective that measures two distinct subsets:
- 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Post-Intervention (Week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Sep 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two arms in a parallel design: (1) Fall prevention education via the iROLL program or (2) Fall prevention education via the STEADI program. Each participant remains in their assigned group throughout the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- University of Illinois Chicago
- Responsible party
- Principal investigator, Laura Rice, University of Illinois at Urbana-Champaign
- Investigators
- Harshal Mahajan, Ph.D., Principal investigator, University of Illinois, Urbana-ChampaignLaura Rice, PhD, MPT, ATP, Principal investigator, University of Illinois, Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167680
- Sponsor's protocol ID
- IRB25-0716
- Other IDs
- 90DPHF0010, 862958
- Status last verified
- May 2026
- First submitted
- 8 Aug 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a mHealth Fall Management Program - Phase III
- ClinicalTrials.gov ID
- NCT07167680
- Acronym / sponsor ID
- IRB25-0716
- Conditions
- Spinal Cord Injuries (SCI), Multiple Sclerosis
- Keywords
- wheelchair, fall prevention, mobile application, spinal cord injury, multiple sclerosis, education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- University of Illinois Chicago
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- One group will use the iROLL-O+ app, which offers personalized fall prevention tools and strategies.
- 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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two arms in a parallel design: (1) Fall prevention education via the iROLL program or (2) Fall prevention education via the STEADI program. Each participant remains in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Individualized reduction of falls (iROLL) Group | Experimental | Procedure: Individualized reduction of falls (iROLL)iROLL 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 comparator | Procedure: Stopping Elderly Accidents, Deaths & Injuries (STEADI)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Individualized reduction of falls (iROLL) Group |
| 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. | Procedure or surgery | Stopping Elderly Accidents, Deaths & Injuries (STEADI) Program Group |
Primary outcome
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
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.
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.
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).
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.
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
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).
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.
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harshal Mahajan, Ph.D. principal investigator
University of Illinois, Urbana-Champaign
Laura Rice, PhD, MPT, ATP principal investigator
University of Illinois, Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized reduction of falls (iROLL) and Stopping Elderly Accidents, Deaths & Injuries (STEADI) in people with Spinal Cord Injuries (SCI) and Multiple Sclerosis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Rice, PhD, MPT, ATP (217-333-4650, ricela@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Currently Employed Technology Scale (time frame: Baseline). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.