Multiple Sclerosis Clinical Trial
— iRollOfficial title:
Validation of a Fall Prevention Program Among Non-Ambulatory Wheeled Mobility Device Users With Multiple Sclerosis
NCT number | NCT03705364 |
Other study ID # | 18124 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | January 1, 2020 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | The Shepherd Center | Atlanta | Georgia |
United States | UIC | Chicago | Illinois |
United States | UIUC | Urbana | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Urbana-Champaign |
United States,
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 |
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