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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Disability Participation and Quality of Life (DPQOL) Laboratory — Urbana

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗