Fall Prevention Program for Non-ambulatory Wheeled Mobility Device Users Living With MS (iRoll)
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fall Management program
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Sclerosis focused on measuring wheelchair, non-ambulatory
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.
Sites / Locations
- The Shepherd CenterRecruiting
- UICRecruiting
- UIUCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Wait List Control Group
Fall Management program
Arm Description
Wait list control group
Intervention arm
Outcomes
Primary Outcome Measures
Reduction in fall incidence
Fall Diary; Construct: to report and track the number of falls experienced; Less number of falls indicates better outcome.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03705364
First Posted
February 27, 2018
Last Updated
April 2, 2019
Sponsor
University of Illinois at Urbana-Champaign
1. Study Identification
Unique Protocol Identification Number
NCT03705364
Brief Title
Fall Prevention Program for Non-ambulatory Wheeled Mobility Device Users Living With MS
Acronym
iRoll
Official Title
Validation of a Fall Prevention Program Among Non-Ambulatory Wheeled Mobility Device Users With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
wheelchair, non-ambulatory
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Wait List Control Group
Arm Type
No Intervention
Arm Description
Wait list control group
Arm Title
Fall Management program
Arm Type
Experimental
Arm Description
Intervention arm
Intervention Type
Other
Intervention Name(s)
Fall Management program
Intervention Description
Comprehensive fall management program that develops strategies for non-ambulatory wheelchair users living with MS to develpo strategies to recover from a fall.
Primary Outcome Measure Information:
Title
Reduction in fall incidence
Description
Fall Diary; Construct: to report and track the number of falls experienced; Less number of falls indicates better outcome.
Time Frame
44 weeks
Secondary Outcome Measure Information:
Title
Management of Fall
Description
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.
Time Frame
44 weeks
Title
Prevention of Fall
Description
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.
Time Frame
44 weeks
Title
Prevention and Management of Fall
Description
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.
Time Frame
44 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Pike, MPH
Phone
217-244-7006
Email
dpqoluiuc@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura A Rice, PhD,MPT,ATP
Organizational Affiliation
Department of Kinesiology and Community Health, College of Applied Health Sciences, University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Shepherd Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Moldavskiy
Phone
404-350-7655
Email
marina_moldavskiy@shepherd.org
First Name & Middle Initial & Last Name & Degree
Deborah Backus, PhD, PT
Facility Name
UIC
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Pike
Phone
217-244-7006
Email
dpqoluiuc@outlook.com
First Name & Middle Initial & Last Name & Degree
Elizabeth W Peterson, PhD,OTR/L
First Name & Middle Initial & Last Name & Degree
Toni Van Denend, MS,OTR/L
Facility Name
UIUC
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Pike
Phone
217-244-7006
Email
dpqoluiuc@outlook.com
First Name & Middle Initial & Last Name & Degree
Laura A Rice, PhD,MPT,ATP
First Name & Middle Initial & Last Name & Degree
JongHun Sun, MS, ATC
First Name & Middle Initial & Last Name & Degree
Rebecca Yarnot, BA
First Name & Middle Initial & Last Name & Degree
Libak Abou, MS, PT
First Name & Middle Initial & Last Name & Degree
Jacob J Sosnoff, PhD
First Name & Middle Initial & Last Name & Degree
Sa Shen, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individuals participant data will not be available to other researchers.
Citations:
PubMed Identifier
31083170
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.
Results Reference
derived
Learn more about this trial
Fall Prevention Program for Non-ambulatory Wheeled Mobility Device Users Living With MS
We'll reach out to this number within 24 hrs