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

Multiple Sclerosis Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03705364
• Other study ID #: 18124
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2019
• Source: University of Illinois at Urbana-Champaign
• Contact: Emily Pike, MPH
• Phone: 217-244-7006
• Email: dpqoluiuc[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Fall Management program
Comprehensive fall management program that develops strategies for non-ambulatory wheelchair users living with MS to develpo strategies to recover from a fall.

Locations

Country	Name	City	State
United States	The Shepherd Center	Atlanta	Georgia
United States	UIC	Chicago	Illinois
United States	UIUC	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in fall incidence	Fall Diary; Construct: to report and track the number of falls experienced; Less number of falls indicates better outcome.	44 weeks
Secondary	Management of Fall	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.	44 weeks
Secondary	Prevention of Fall	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.	44 weeks
Secondary	Prevention and Management of Fall	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.	44 weeks