Clinical trial NCT03705364: Fall Prevention Program for Non-ambulatory Wheeled Mobility Device Users Living With MS
Official title: Validation of a Fall Prevention Program Among Non-Ambulatory Wheeled Mobility Device Users With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: wheelchair
non-ambulatory
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A research study to examine the effectiveness of a fall management program to prevent falls and develop fall recovery strategies for wheeled mobility device users living with Multiple Sclerosis.

Detailed description: Falls are a serious concern for wheelchair and scooter users with Multiple Sclerosis (MS). Approximately 75% of the population reports at least one fall in a 6-month period and nearly half report frequent falls. Falls can result in physical injuries and contribute to activity curtailment. Despite the negative consequences, limited evidenced-based fall prevention programs designed specifically for wheelchair and scooter users with MS exist.

Recognizing the threat falls pose to health and well-being and the dearth of fall prevention programs, the purpose of this study to perform a structured process evaluation and examine the feasibility and efficacy of a community-based intervention specifically designed to reduce fall incidence among wheelchair and scooter users with MS. Secondary aims of the intervention are to improve functional mobility skills associated with fall risk (e.g. transfer and wheelchair skills, balance), increase knowledge of fall risk factors, decrease fear of falling and enhance quality of life and community participation.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Multiple Sclerosis
2. \>18 years old
3. Main form of mobility is via a wheeled mobility device (Patient Determined Disease Steps Level 7)
4. Self reported ability to transfer with moderate assistance or less
5. Self-reported fall history (at least 1 fall/12 months)

Exclusion Criteria:

1. MS exacerbation in the past 30 days
2. Received a score of 10 or above to the Short Blessed Test (attached)
3. Inability to sit upright for at least 1 hour.

Primary outcomes:
measure: Reduction in fall incidence
timeFrame: 44 weeks
Secondary outcomes:
measure: Management of Fall
timeFrame: 44 weeks
measure: Prevention of Fall
timeFrame: 44 weeks
measure: Prevention and Management of Fall
timeFrame: 44 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: The Shepherd Center
state: Georgia
city: Chicago
country: United States
facility: UIC
state: Illinois
city: Urbana
country: United States
facility: UIUC
state: Illinois
Study officials:
affiliation: Department of Kinesiology and Community Health, College of Applied Health Sciences, University of Illinois at Urbana-Champaign
name: Laura A Rice, PhD,MPT,ATP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rice LA, Peterson EW, Backus D, Sung J, Yarnot R, Abou L, Van Denend T, Shen S, Sosnoff JJ. Validation of an individualized reduction of falls intervention program among wheelchair and scooter users with multiple sclerosis. Medicine (Baltimore). 2019 May;98(19):e15418. doi: 10.1097/MD.0000000000015418.