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

Shirley Ryan AbilityLab

Status

Active, not recruiting

Conditions

Poliomyelitis

Spinal Cord Injuries

Arthritis

Post-polio Syndrome

Lower Motor Neurone Lesion

Treatments

Device: C-brace

Device: Stance control orthosis

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02089880

85951

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.