Mobile Weight-Support Therapy (MWeST) for Mobility After... | NCT03864367

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

NCT03864367

Sponsor

Washington University School of Medicine

Status

Withdrawn

Last Update Posted

Jan 7, 2021Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Distal Femur Fracture

Interventions

Device - Prism Medical FGA-700 Bariatric Floor Lift

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI decided to end the study

Expanded Access Info

Start Date

Jan 28, 2019Actual

Primary Completion Date

Jan 2021Estimated

Completion Date

Jan 5, 2021Actual

First Submitted Date

Jan 31, 2019

First Submission Date that Met QC Criteria

Mar 4, 2019

First Posted Date

Mar 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 5, 2021

Last Update Posted Date

Jan 7, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: Device - Prism Medical FGA-700 Bariatric Floor Lift
Control		This group will only receive regular physical therapy.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Device - Prism Medical FGA-700 Bariatric Floor Lift	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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Study population is anyone 55 years of age and older with a distal femur fracture.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ANNA N MILLER, MD	Washington University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington University in St. Louis		St Louis	Missouri	63110	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

This is a single site study.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000092524	Femoral Fractures, Distal

Ancestor Terms

ID	Term
D005264	Femoral Fractures
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries

Browse Leaves

Not provided

Browse Branches

Not provided