The IM ABLE Study: A Study of Warriors & Veterans Following Neuromusculoskeletal Injury of the Lower Limb
The IM ABLE Study: A Cross-Sector, Multisite Initiative to Advance Care for Warriors and Veterans Following Neuromusculoskeletal Injury of the Lower Limb
2 other identifiers
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedStudy Start
First participant enrolled
February 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMarch 20, 2019
March 1, 2019
1.3 years
March 29, 2017
March 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (3)
Perceived Function
At week 2 and week 4
Pain
At week 2 and week 4
Safety will be measured with the Activities Balance Confidence Scale
At week 2 and week 4
Study Arms (2)
Advanced orthotic brace
EXPERIMENTALConventional orthotic brace
ACTIVE COMPARATORInterventions
Participants will use an advanced exoskeletal orthosis.
Participants will use the standard of care orthosis
Eligibility Criteria
You may qualify if:
- Lower extremity injury of any etiology requiring use of an AFO
- Male or Female, of any ethnicity
- yrs of age
- lbs
- ≥ 1 yr. of orthotic experience
You may not qualify if:
- Body weight \<100 or \>275 lbs
- Does not speak English or Spanish
- Known cognitive impairment (i.e. Diagnoses such as Traumatic Brain Injury, Dementia)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- James A. Haley Veterans Administration Hospitalcollaborator
- VA New York Harbor Healthcare Systemcollaborator
- Hanger Clinic: Prosthetics & Orthoticscollaborator
Study Sites (2)
New York VA
New York, New York, 10010, United States
Hanger, Inc
Houston, Texas, 77025, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 29, 2017
First Posted
April 11, 2017
Study Start
February 22, 2018
Primary Completion
June 1, 2019
Study Completion
September 1, 2019
Last Updated
March 20, 2019
Record last verified: 2019-03