Lower Extremity Clinical Trial
Official title:
The IM ABLE Study: A Cross-Sector, Multisite Initiative to Advance Care for Warriors and Veterans Following Neuromusculoskeletal Injury of the Lower Limb
Verified date | March 2019 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | September 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Lower extremity injury of any etiology requiring use of an AFO 2. Male or Female, of any ethnicity 3. 18-65 yrs of age 4. 100-275 lbs 5. = 1 yr. of orthotic experience Exclusion Criteria: 1. Body weight <100 or >275 lbs 2. Does not speak English or Spanish 3. Known cognitive impairment (i.e. Diagnoses such as Traumatic Brain Injury, Dementia) |
Country | Name | City | State |
---|---|---|---|
United States | Hanger, Inc | Houston | Texas |
United States | New York VA | New York | New York |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | Hanger Clinic: Prosthetics & Orthotics, James A. Haley Veterans Administration Hospital, VA New York Harbor Healthcare System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Pain | Pain rating scale 0-10 | At week 2 and week 4 | |
Secondary | Safety will be measured with the Activities Balance Confidence Scale | Safety will be measured with the Activities Balance Confidence Scale, a 16 item self-report measure of perceived balance confidence | At week 2 and week 4 |
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