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

Withdrawn

• Conditions: Distal Femur Fracture
• Interventions: Device: Device - Prism Medical FGA-700 Bariatric Floor Lift

• Registration Number: NCT03864367
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-01-28
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-03-04
• Study First Posted: 2019-03-06
• Status Verified: 2021-01
• Primary Completion: 2021-01
• Study Completion: 2021-01-05
• Last Update Submitted: 2021-01-05
• Last Update Posted: 2021-01-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

• patients unable to walk without any assistive devices post-injury
• patients too medically unstable to participate in physical therapy

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device	Device - Prism Medical FGA-700 Bariatric Floor Lift	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.

Primary Outcome Measures

Name	Time	Method
Walking with device	1 year	Determining if the Mobile Weight-Support device helps improve mobility after injury compared to walking without device.

Trial Locations

Locations (1)

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States