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Clinical Trials/NCT03705364
NCT03705364
Unknown
Not Applicable

Validation of a Fall Prevention Program Among Non-Ambulatory Wheeled Mobility Device Users With Multiple Sclerosis

University of Illinois at Urbana-Champaign3 sites in 1 country120 target enrollmentMarch 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
120
Locations
3
Primary Endpoint
Reduction in fall incidence
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
January 1, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Reduction in fall incidence

Time Frame: 44 weeks

Fall Diary; Construct: to report and track the number of falls experienced; Less number of falls indicates better outcome.

Secondary Outcomes

  • Prevention of Fall(44 weeks)
  • Prevention and Management of Fall(44 weeks)
  • Management of Fall(44 weeks)

Study Sites (3)

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