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

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.

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.

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.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.