NCT02089880

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

Micro-processor Controlled Knee-Ankle-Foot Orthosis (C-Brace) Versus Stance-control Knee-Ankle-Foot Orthosis (SCO): Functional Outcomes in Individuals With Lower Extremity Impairment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spinal Cord Injuries
• Poliomyelitis
• Post-polio Syndrome
• Arthritis
• Lower Motor Neurone Lesion

Interventions

Type	Name	Description
DEVICE	C-brace	The participant will receive 6 sessions of training over a one month period in using the C-brace in all levels of functional gait. The participant will then continue use of the C-brace for one month following training. The C-Brace from Otto Bock is an orthosis that controls throughout stance and swing phases of gait with a micro-processor (MP) controlled knee.
DEVICE	Stance control orthosis	The participant will receive 6 sessions of training over a one month period in using his current stance control knee-ankle-foot orthosis (SCO) in all levels of functional gait. The participant will then continue use of the SCO for one month following training. The SCO controls the knee by maintaining it straight and extended during the stance phase of gait.

Timeline

• Start date: 2014-02-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2014-03-18
• Last updated: 2025-05-01

Locations

1 site across 1 country: United States