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

April 2, 2019 updated by: University of Illinois at Urbana-Champaign

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • The Shepherd Center
        • Contact:
        • Sub-Investigator:
          • Deborah Backus, PhD, PT
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • UIC
        • Contact:
        • Sub-Investigator:
          • Elizabeth W Peterson, PhD,OTR/L
        • Sub-Investigator:
          • Toni Van Denend, MS,OTR/L
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • UIUC
        • Contact:
        • Principal Investigator:
          • Laura A Rice, PhD,MPT,ATP
        • Sub-Investigator:
          • JongHun Sun, MS, ATC
        • Sub-Investigator:
          • Rebecca Yarnot, BA
        • Sub-Investigator:
          • Libak Abou, MS, PT
        • Sub-Investigator:
          • Jacob J Sosnoff, PhD
        • Sub-Investigator:
          • Sa Shen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Wait List Control Group
Wait list control group
Experimental: Fall Management program
Intervention arm
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
44 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Management of Fall
Time Frame: 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.
44 weeks
Prevention of Fall
Time Frame: 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.
44 weeks
Prevention and Management of Fall
Time Frame: 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.
44 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Investigators

  • Principal Investigator: Laura A Rice, PhD,MPT,ATP, Department of Kinesiology and Community Health, College of Applied Health Sciences, University of Illinois at Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

February 27, 2018

First Submitted That Met QC Criteria

October 9, 2018

First Posted (Actual)

October 15, 2018

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18124

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individuals participant data will not be available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple Sclerosis

Clinical Trials on Fall Management program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe