Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis

Running, not enrolling · Not applicable

Conditions studied: Spinal Cord Injuries, Poliomyelitis, Post-polio Syndrome, Arthritis, Lower Motor Neurone Lesion

In brief

The study will specifically evaluate the potential of the C-Brace to improve the functional mobility and quality of life in individuals with lower extremity impairments due to neurologic or neuromuscular disease, orthopedic disease or trauma, as compared to the stance control orthosis.

Key facts

Study ID

NCT02089880

Run by

Shirley Ryan AbilityLab

People needed

24

Starts

2014-02-01

Expected to finish

2025-12-01

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Lower extremity functional impairment due to neurologic or neuromuscular disease, orthopedic disease or trauma.
• Prior active and compliant use of unilateral Knee-ankle-foot orthosis (KAFO) or Stance control orthosis (SCO).
• Age 18 - 80 years.
• Demonstrate a reciprocal gait pattern using the SCO and C-Brace trial tools.
• Cognitive ability to understand and the willingness to sign a written informed consent.
• Subjects must be able to demonstrate the ability to turn the global positioning sensor (GPS) and Actigraph units on and off and sufficient memory ability to wear the devices each day during use of the orthoses.

You may not qualify if…

• Passive ankle range of motion (PROM) of the lower extremity requiring the knee-ankle-foot orthosis (KAFO) of less than 2 degrees.
• Body weight >275 pounds.
• Unstable neurological or cardiovascular/pulmonary disease, cancer.
• Knee flexion contracture resulting in the inability to actively use C-Brace or SCO.
• Participating in physical therapy currently or within 1 month of starting protocol, specific to orthotic use and gait training.

Where it is running

• Rehabilitation Institute of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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