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

NCT03107728 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-03-20

No results posted yet for this study

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

Interventions

DEVICE

Advanced orthotic brace

Participants will use an advanced exoskeletal orthosis.

DEVICE

Conventional orthotic brace

Participants will use the standard of care orthosis

Sponsors & Collaborators

  • James A. Haley Veterans Administration Hospital

    collaborator FED

  • VA New York Harbor Healthcare System

    collaborator FED

  • Hanger Clinic: Prosthetics & Orthotics

    collaborator OTHER

  • University of South Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2019-06-30
Completion
2019-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03107728 on ClinicalTrials.gov