The IM ABLE Study: A Study of Warriors & Veterans Followi... | NCT03107728

Studies
The IM ABLE Study: A Study of Warriors & Veterans Following Neuromusculoskeletal Injury of the Lower Limb

NCT03107728

Sponsor

University of South Florida

Status

Unknown status

Last Update Posted

Mar 20, 2019Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Limb Salvage
Braces
Lower Extremity

Interventions

Advanced orthotic brace
Conventional orthotic brace

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

ID	Type	Description	Link
W81XWH-16-1-0738	Other Grant/Funding Number	USAMRAA

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2018Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

Mar 29, 2017

First Submission Date that Met QC Criteria

Apr 10, 2017

First Posted Date

Apr 11, 2017Actual

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

Mar 18, 2019

Last Update Posted Date

Mar 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jason Highsmith, Associate Professor, University of South FloridaPrincipal Investigator

Lead Sponsor

University of South FloridaOTHER

Collaborators

Name	Class
James A. Haley Veterans Administration Hospital	FED
VA New York Harbor Healthcare System	FED
Hanger Clinic: Prosthetics & Orthotics	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the IM ABLE(Injuries Managed with Advanced Bracing for Lower Extremities) study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.

Detailed Description

There were approximately 20,000 extremity trauma cases associated with the wars in Iraq and Afghanistan. Many of these individuals have experienced multiple limb-sparing surgeries and orthotic utilization. Many continue functioning with use of their orthosis while others may seek delayed amputation. It is unclear if limb salvage or amputation is more advantageous functionally or preferred following lower extremity(LE) trauma. The IDEO (Intrepid Dynamic Exoskeletal Orthosis) was developed to assist in maintaining high functional performance in patients who have experienced high energy lower extremity trauma (HELET) and limb salvage surgeries primarily effecting the LE below the level of the knee joint. The IDEO represents one "advanced" orthotic option for a traumatized and surgically spared limb however there are other "advanced" orthotic options. Problematically, few studies have reported outcomes associated with these devices. In the few studies available, sample sizes are small which greatly reduces generalizability of study findings. The purpose of the IM ABLE study is to determine if advanced (ADV) ankle foot orthoses (AFOs) will enable users to achieve greater levels of physical and self-reported function compared with conventional (CONV) AFOs for those ambulating at or above the independent community level of ambulation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Advanced orthotic brace	Experimental		Device: Advanced orthotic brace
Conventional orthotic brace	Active Comparator		Device: Conventional orthotic brace

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Advanced orthotic brace	Device	Participants will use an advanced exoskeletal orthosis.	Advanced orthotic brace

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Mobility	Mobility will be assessed with the Timed Up & Go test. subjects are timed while they rise from a chair, walk 3m, turn around, return to the chair and sit down again. Patients are usually permitted to use a walking aid, but not to use physical assistance.	Mobility will be assessed at Week 2 and Week 4
Change in Ambulatory Function	The 2 Minute Walk Test will be used to assess ambulatory function	Ambulatory Function will be assessed at week 2 and week 4.

Secondary Outcomes

Measure	Description	Time Frame
Perceived Function	Perceived Function will be assessed via the EQ-5D (EuroQol 5D), a five item ordinally scaled patient self-report.	At week 2 and week 4
Pain	Pain rating scale 0-10

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Lower extremity injury of any etiology requiring use of an AFO
Male or Female, of any ethnicity
18-65 yrs of age
100-275 lbs
≥ 1 yr. of orthotic experience

Exclusion Criteria:

Body weight <100 or >275 lbs
Does not speak English or Spanish
Known cognitive impairment (i.e. Diagnoses such as Traumatic Brain Injury, Dementia)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York VA	Recruiting	New York	New York	10010	United States