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

NCT ID: NCT03705364

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-01-01

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Wait List Control Group

Wait list control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Fall Management program

Intervention arm

Group Type EXPERIMENTAL

Fall Management program

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laura A Rice, PhD,MPT,ATP

Role: PRINCIPAL_INVESTIGATOR

Department of Kinesiology and Community Health, College of Applied Health Sciences, University of Illinois at Urbana-Champaign

Locations

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The Shepherd Center

Atlanta, Georgia, United States

Site Status RECRUITING

UIC

Chicago, Illinois, United States

Site Status RECRUITING

UIUC

Urbana, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Emily Pike, MPH

Role: CONTACT

217-244-7006

Facility Contacts

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Marina Moldavskiy

Role: primary

404-350-7655

Emily Pike

Role: primary

217-244-7006

Emily Pike

Role: primary

217-244-7006

References

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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.

Reference Type DERIVED
PMID: 31083170 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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18124

Identifier Type: -

Identifier Source: org_study_id

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