UnknownNot Applicable

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

United States120 participantsStarted 2018-02-22

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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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)

What they're measuring

Change in Mobility

Timeframe: Mobility will be assessed at Week 2 and Week 4

Change in Ambulatory Function

Timeframe: Ambulatory Function will be assessed at week 2 and week 4.

Trial details

NCT IDNCT03107728

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06

View on ClinicalTrials.gov More Limb Salvage trials