Mobile Weight-Support Therapy (MWeST) for Mobility After Geriatric Fracture

NCT ID: NCT03864367

Last Updated: 2021-01-07

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-28

Study Completion Date

2021-01-05

Brief Summary

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This is a two-year study proposal to assess feasibility of MWeST (Mobile Weight-Support Therapy) implementation after geriatric fracture and its effects on functional and patient-reported outcomes.

The goal of this study is to improve mobilization of geriatric lower extremity trauma patients, with the aim of improving overall functional and patient-reported outcomes while decreasing complications and readmissions. Almost 50% of the adult population in the United States has osteopenia or osteoporosis, with over 2 million fragility fractures per year and a projected $25 billion in costs by 2025. These patients are at high risk for readmission due to complications, and at increased risk of mortality with these complications. Sarcopenia, a generalized loss of skeletal muscle associated with aging, has also been associated with increased disability and increased risk of future fracture in these patients. The investigator's study aims to assess the value of weight-support therapy for geriatric patients with lower extremity trauma in improving their overall risk of future injury and disability.

Detailed Description

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The goal of this study is to improve mobilization of geriatric lower extremity trauma patients, with the aim of improving overall functional and patient-reported outcomes while decreasing complications and readmissions. Almost 50% of the adult population in the United States has osteopenia or osteoporosis, with over 2 million fragility fractures per year and a projected $25 billion in costs by 2025. These patients are at high risk for readmission due to complications, and at increased risk of mortality with these complications. Sarcopenia, a generalized loss of skeletal muscle associated with aging, has also been associated with increased disability and increased risk of future fracture in these patients. The investigator's study aims to assess the value of weight-support therapy for geriatric patients with lower extremity trauma in improving their overall risk of future injury and disability.

Conditions

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Distal Femur Fracture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Device

This group will use the MWeST lift device along with regular physical therapy. The lift device is the Prism Medical FGA-700 Bariatric Floor Lift including a sling to assist in walking.

Device - Prism Medical FGA-700 Bariatric Floor Lift

Intervention Type DEVICE

This group will be using a Mobile Weight-Support Therapy (MWeST) device (the Prism Medical FGA-700 Bariatric Floor Lift) to determine if it improves mobilization of older patients with traumas of their legs.

Control

This group will only receive regular physical therapy.

No interventions assigned to this group

Interventions

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Device - Prism Medical FGA-700 Bariatric Floor Lift

This group will be using a Mobile Weight-Support Therapy (MWeST) device (the Prism Medical FGA-700 Bariatric Floor Lift) to determine if it improves mobilization of older patients with traumas of their legs.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 55 and older
* distal femur fracture
* able to walk prior to fracture

Exclusion Criteria

* patients unable to walk without any assistive devices post-injury
* patients too medically unstable to participate in physical therapy
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ANNA N MILLER, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University in St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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201805050

Identifier Type: -

Identifier Source: org_study_id

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