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Recruiting NCT07167680

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

No phase Interventional Spinal Cord Injuries (SCI) Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individualized reduction of falls (iROLL), Stopping Elderly Accidents, Deaths & Injuries (STEADI).
Who it may be relevant to
Registry conditions: Spinal Cord Injuries (SCI), Multiple Sclerosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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 ap
  • 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.

Primary outcome measures

  • Functional Assessment of Currently Employed Technology Scale [Time frame: Baseline]
  • Fall Concerns Scale for Wheelchair and Scooter Users [Time frame: Baseline, Post-Intervention (Week 6 and Week 14)]
  • Falls Prevention Strategies Survey [Time frame: Baseline, Post-Intervention (Week 6 and Week 14)]
  • The Fall Management Scale [Time frame: Baseline, Post-Intervention (Week 6 and Week 14)]
  • Fall Prevention and Management Questionnaire [Time frame: Baseline, Post-Intervention (Week 6 and Week 14)]
  • Community Participation Indicators Questionnaire [Time frame: Baseline, Post-Intervention (Week 6 and Week 14)]
  • Transfer Assessment Instrument Questionnaire [Time frame: Baseline, Post-Intervention (Week 6 and Week 14)]
  • Wheelchair Skills Test - Questionnaire [Time frame: Baseline, Post-Intervention (Week 6 and Week 14)]
  • System Usability Scale [Time frame: Post-Intervention (Week 6)]
  • Usefulness, Satisfaction, and Ease of Use Questionnaire [Time frame: Post-Intervention (Week 6)]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Disability Participation and Quality of Life (DPQOL) Laboratory — Urbana

Identifiers

NCT: NCT07167680 · IRB25-0716 · 90DPHF0010 · 862958

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗