Recruiting

ADV & CONV AFOs

Sponsor:

University of South Florida

Code:

NCT03107728

Conditions

Limb Salvage

Braces

Lower Extremity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Advanced orthotic brace

Conventional orthotic brace

Study Details

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.

Conditions

Limb Salvage

Braces

Lower Extremity

Study ID

NCT03107728

Start date

Feb 22, 2018

Status verified date

Mar, 2019

Completion date

Sep, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Advanced orthotic brace

active comparator: Conventional orthotic brace

Interventions

Advanced orthotic brace

Participants will use an advanced exoskeletal orthosis.

Conventional orthotic brace

Participants will use the standard of care orthosis

Primary outcome measure

  • Change in Mobility [ Time Frame: Mobility will be assessed at Week 2 and Week 4 ]
  • Change in Ambulatory Function [ Time Frame: Ambulatory Function will be assessed at week 2 and week 4. ]

Central Contacts and Locations

Locations

New York VA

Recruiting

New York, New York, United States, 10010

Contacts

Jason Maikos, PhD

212-686-7500jason.maikos@va.gov

Hanger, Inc

Recruiting

Houston, Texas, United States, 77025

Contacts

Shane Wurdeman, PhD

402-290-8051swurdeman@hanger.com

More Information

Sponsor

University of South Florida

Last update posted

Mar 20, 2019

Last verified

Mar, 2019

Keywords

  • orthotics
  • high-energy lower extremity trauma
  • physical therapy
  • bracing
  • functional performance
  • performance assessment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2019-03-20.