Fall Prevention Program for Non-ambulatory Wheeled Mobility Device Users Living With MS

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Other: Fall Management program

• Registration Number: NCT03705364
• Lead Sponsor: University of Illinois at Urbana-Champaign

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.

Study Timeline

• Study First Submitted: 2018-02-27
• Study Start: 2018-03-01
• Study First Submitted QC: 2018-10-09
• Study First Posted: 2018-10-15
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fall Management program	Fall Management program	Intervention arm

Primary Outcome Measures

Name	Time	Method
Reduction in fall incidence	44 weeks	Fall Diary; Construct: to report and track the number of falls experienced; Less number of falls indicates better outcome.

Secondary Outcome Measures

Name	Time	Method
Prevention of Fall	44 weeks	Falls Prevention Strategies Survey (FPSS); Construct: to measure the use of fall prevention strategies; Scale range: 0 - 22, higher scores reflect more regular use of more fall prevention strategies; Never do: 0, Do sometimes: 1, Do regularly: 2; Items are summed to get the final score.
Prevention and Management of Fall	44 weeks	Falls Prevention and Management Questionnaire (FPMQ); Construct: to measure the ability to prevent and manage falls; Scale range: 0 - 48, higher scores indicate higher ability to prevent and manage falls; Items are scored from 0 ("strongly disagree") to 4 ("strongly agree"); Items are summed to get the final score.
Management of Fall	44 weeks	Fall Management Scale (FMS); Construct: to measure the perceived ability to manage risk of falls or actual falls; Scale range: 5 - 45, higher scores indicate lower degree of confidence; Items are summed to get the final score.

Trial Locations

Locations (3)

UIUC; 🇺🇸 Urbana, Illinois, United States

The Shepherd Center; 🇺🇸 Atlanta, Georgia, United States

UIC; 🇺🇸 Chicago, Illinois, United States